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Original paper
Ondansetron combined with ST36 (Zusanli) acupuncture point injection for postoperative vomiting Zi Y Chen,1,2 Ling Lin,3 Huan H Wang,4 Yong Zhou,5 Jian Q Yan,1 Yi L Huang,1 Qu L Guo1
1
Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan, PR China 2 Department of Anesthesiology, Hunan Provincial Tumor Hospital, Changsha, Hunan, PR China 3 National Hepatobiliary and Enteric Surgery Research Center, Xiangya Hospital, Central South University, Changsha, Hunan, PR China 4 Department of Acupuncture and Moxibustion, Xiangya Hospital, Central South University, Changsha, Hunan, PR China 5 Department of Physiology, Xiangya School of Medicine, Central South University, Changsha, Hunan, PR China Correspondence to Qu L Guo, Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan 410008, PR China; [email protected] Received 27 February 2013 Accepted 30 December 2013 Published Online First 17 January 2014
To cite: Chen ZY, Lin L, Wang HH, et al. Acupunct Med 2014;32:124–131.
124
ABSTRACT Background Ondansetron, sometimes combined with acustimulation at PC6 (Neiguan), is commonly used for preventing postoperative nausea and vomiting, but PC6 is not the only point that can be used for this purpose. Objectives To evaluate the combined effects of ondansetron and ST36 (Zusanli) acupuncture point injection on postoperative vomiting (POV) after laparoscopic surgery. Methods A randomised, patient and assessorblinded, placebo-controlled clinical study was conducted. One hundred and sixty patients undergoing laparoscopic surgery were randomly assigned to one of four groups: (1) group P (placebo-control): intravenous normal saline +bilateral non-acupuncture point injection of vitamin B1 (n=40); (2) group O (ondansetron): intravenous ondansetron+bilateral ST36 sham injection (n=40); (3) group A (acupuncture point injection): intravenous normal saline+bilateral acupuncture point injection at ST36 of vitamin B1 (n=40); (4) group C (combination): intravenous ondansetron+bilateral acupuncture point injection at ST36 of vitamin B1 (n=40). Interventions were made on arrival at the postanaesthesia care unit. The primary outcome was the incidence of POV within 24 h after the operation. Secondary outcomes included severity of vomiting, incidence of rescue treatment, patients’ satisfaction and the first anal exsufflation time 24 h after the operation. Results The incidence of POV within 24 h postoperative period in each group was P 33%; O 11%, A 9% and C 6%. Outcomes for all intervention groups were significantly better than that for placebo (p18 years, were eligible if scheduled to undergo a laparoscopy procedure (eg, gynaecological laparoscopic surgery or laparoscopic cholecystectomy). Patients were excluded31–33 if they had vomited or retched within 24 h before surgery, had taken an antiemetic, glucocorticosteroid or psychoactive drug within 24 h before the surgery, had an implanted cardiac pacemaker or defibrillator, had had their surgical technique changed, had any infectious disease within 2 weeks before surgery, had local infection near acupuncture points, or were pregnant or had menstrual symptoms, or were allergic to
Figure 1
vitamin B1. After giving written, informed consent, 160 patients were finally included in this study (see below). In view of the considerable impact of gender on POV, volunteers were stratified by gender. Thirty-two men and 128 women were allocated to four groups by simple randomisation, using computer-generated random numbers, concealed until the patient entered the postanaesthesia care unit (PACU). 1. Group P ( placebo-control group) : intravenous normal saline (4 mL)+bilateral injection of vitamin B1 into nonacupuncture point (100 mg:2 mL)/side (n=40). 2. Group O (ondansetron group): intravenous ondansetron (8 mg:4 mL)+bilateral ST36 sham injection: the needle touched the skin but no injection was given (n=40). 3. Group A (acustimulation group): intravenous normal saline (4 mL)+bilateral acupuncture point injection at ST36 of vitamin B1 (100 mg:2 mL)/side (n=40). 4. Group C (combination group): intravenous ondansetron +bilateral acupuncture point injection at ST36 of vitamin B1 (100 mg:2 mL)/side (n=40).
Detailed medical histories and demographic information were obtained from each patient. Finger-cun (eg, 1.0 and 3.0 cun) were measured and recorded in advance before the patient entered the operating room. ST36 is located 3.0 cun inferior to the lateral depression underneath the patellar ligament, and one middlefinger breadth lateral to the tibial crest (figure 1A). A standardised anaesthesia regimen was used. Phenobarbital sodium (0.1 g intrasmuscular) and atropine (0.5 mg intrasmuscular) were administered for premedication half an hour before entering the operating theatre. Standard monitors were used during the intraoperative period to measure pulse oxygen saturation, heart rate, blood pressure and end-tidal CO2 gas tension. Anaesthesia was induced with midazolam (0.06–0.10 mg/kg intravenous (IV)), fentanyl (0.004– 0.008 mg/kg IV), cisatracurium (0.15–0.20 mg/kg IV) and etomidate (0.20–0.40 mg/kg IV). Anaesthesia was maintained with propofol (4–8 mg/kg/h IV), sevoflurane (0.8–2%, inspired concentration) and
(A) Location of ST36 and the non-acupuncture point. (B) Dressing over ST36 and the non-acupuncture point.
Chen ZY, et al. Acupunct Med 2014;32:124–131. doi:10.1136/acupmed-2013-010340
125
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Original paper atracurium (5 mg/kg/h IV) after endotracheal intubation. The pneumoperitoneum pressure range was set to 14– 16 mm Hg. After induction of anaesthesia, levobupivacaine 0.25% (3 mL per incision, a total of 9 mL per patient) was infiltrated in all patients before skin incisions for trocar insertion. Opioid analgesics were also standardised perioperatively. If needed, supplemental bolus doses of fentanyl (0.002 mg/kg IV) were given for intraoperative analgesia. All patients received flurbiprofen (50 mg IV, for >1 min) at the end of surgery. Premedication, intraoperative anaesthetics, the duration of anaesthesia and surgery were documented, the duration of carbon dioxide (CO2) pneumoperitoneum,34 consumption of fentanyl,2 25 35 propofol and sevoflurane,36–38 which may influence the outcomes, were also documented. On arrival in the PACU, patients received either normal saline (4 mL IV)—groups P and A, or, ondansetron (8 mg:4 mL IV)—groups O and C, from a nurse using identical-appearing syringes, and underwent standardised acupuncture. Bilateral acupuncture point injection at ST36 was carried out using vitamin B1 injection. The bilateral non-acupuncture point injection of vitamin B1 was given 1.0 cun lateral to ST36 (figure 1A). The ST36 and non-acupuncture points of all patients were covered with adhesive tapes, 5×5 cm2, to blind both patients and investigators (figure 1B). Acupuncture was performed by a licensed acupuncture practitioner, following a standardised protocol complying with the basic principles of the Clean Needle Technique Manual for Acupuncturists,14 39 40 using one sterile, disposable 5 mL syringe ( Jie Rui, Shandong, P. R. China), with a stainless-steel needle (diameter 0.7 mm), and vitamin B1 injection solution (Tian Wu, Tianjin, P. R. China) 2 mL (100 mg). Acupuncture points were prepared with iodine. The needle with syringe was inserted perpendicularly at the ST36 point (groups C and A) or non-acupuncture point (group P). When the needle reached a depth of about 1.0–1.5 cun, and at the point where the acupuncturist normally would obtain the ‘de qi sensation’, the syringe piston was withdrawn to ensure that the needle did not penetrate blood vessels. At this point 2 mL vitamin B1 was injected, the needle was pulled out, and pressure exerted over the injection site for 3 min with a disinfectant swab. When it was clear that there was no bleeding, the site was covered with adhesive tape until the final assessment. The residual neuromuscular blockade was reversed with a combination of neostigmine (0.02 mg/ kg IV) and atropine (0.01 mg/kg IV). Patients were observed for 24 h in PACU and wards by an observer who was blinded to the research design. Any adverse events occurring during the acupuncture point injection were also recorded carefully. Patients, anaesthetists, surgical, nursing staff and our follow-up investigators were all blinded to the group 126
allocation. The investigator responsible for collecting data was also unaware of the treatments assigned. Evaluation of study endpoints
The primary outcome was the incidence of POV among the groups within 24 h after the operation, checked at predetermined intervals,30 and expressed as a percentage. The definition of vomiting in this study was ejection of the stomach contents up to, or out of, the mouth, including retching, laboured contractions of the abdominal wall muscles without the expulsion of gastric content. The severity of POV was classified by the number of episodes during a given observation period as follows: 0=none, 1=mild (one or two times), 2=moderate (three or four times), and 3=severe (five or more times). For overall evaluation of treatment efficacy, we used the 24 h total count of patients with vomiting of any severity. This 24 h total count for vomiting was transformed into the count for non-vomiting and was used for calculation of the OR and number needed to treat (NNT). Secondary outcomes included (1) incidence of rescue antiemetic drug use; (2) patients’ satisfaction with POV management; (3) time for the first anal exsufflation; (4) incidence of adverse reactions associated with acupuncture, 24 h after the operation. Any patient who vomited, or who requested a rescue antiemetic drug (when they had severe nausea) in the PACU or the ward, was given IV droperidol 0.625 mg at the first rescue, IV dexamethasone 4 mg at the second rescue and ondansetron 1 mg at the third rescue, if needed. Any patient who had excruciating pain after surgery received an IM injection of 100 mg tramadol as rescue analgesia therapy. Patients’ consent was needed for any remedial treatment. At 24 h after surgery, the anal exsufflation time was evaluated. Patients were also asked whether they had any unpleasant sensation associated with their leg. Their satisfaction with POV management was assessed on a five-point rating scale: 0=very unsatisfied; 1=unsatisfied, 2=normal, 3=satisfied, 4=very satisfied. Statistical analysis
Data were analysed with SPSS V.13.0 for Windows. All continuous variables are presented as means±SD, numbers or percentages, and analysed by one-way analysis of variance, with the least significant difference (LSD) or Student–Newman–Keuls test performed for post hoc multiple comparisons when equal variances were assumed; or by the Kruskal–Wallis test when equal variances were not assumed. Categorical data were analysed using the χ2 and the Kruskal–Wallis tests. A value of p
Original paper
Ondansetron combined with ST36 (Zusanli) acupuncture point injection for postoperative vomiting Zi Y Chen,1,2 Ling Lin,3 Huan H Wang,4 Yong Zhou,5 Jian Q Yan,1 Yi L Huang,1 Qu L Guo1
1
Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan, PR China 2 Department of Anesthesiology, Hunan Provincial Tumor Hospital, Changsha, Hunan, PR China 3 National Hepatobiliary and Enteric Surgery Research Center, Xiangya Hospital, Central South University, Changsha, Hunan, PR China 4 Department of Acupuncture and Moxibustion, Xiangya Hospital, Central South University, Changsha, Hunan, PR China 5 Department of Physiology, Xiangya School of Medicine, Central South University, Changsha, Hunan, PR China Correspondence to Qu L Guo, Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan 410008, PR China; [email protected] Received 27 February 2013 Accepted 30 December 2013 Published Online First 17 January 2014
To cite: Chen ZY, Lin L, Wang HH, et al. Acupunct Med 2014;32:124–131.
124
ABSTRACT Background Ondansetron, sometimes combined with acustimulation at PC6 (Neiguan), is commonly used for preventing postoperative nausea and vomiting, but PC6 is not the only point that can be used for this purpose. Objectives To evaluate the combined effects of ondansetron and ST36 (Zusanli) acupuncture point injection on postoperative vomiting (POV) after laparoscopic surgery. Methods A randomised, patient and assessorblinded, placebo-controlled clinical study was conducted. One hundred and sixty patients undergoing laparoscopic surgery were randomly assigned to one of four groups: (1) group P (placebo-control): intravenous normal saline +bilateral non-acupuncture point injection of vitamin B1 (n=40); (2) group O (ondansetron): intravenous ondansetron+bilateral ST36 sham injection (n=40); (3) group A (acupuncture point injection): intravenous normal saline+bilateral acupuncture point injection at ST36 of vitamin B1 (n=40); (4) group C (combination): intravenous ondansetron+bilateral acupuncture point injection at ST36 of vitamin B1 (n=40). Interventions were made on arrival at the postanaesthesia care unit. The primary outcome was the incidence of POV within 24 h after the operation. Secondary outcomes included severity of vomiting, incidence of rescue treatment, patients’ satisfaction and the first anal exsufflation time 24 h after the operation. Results The incidence of POV within 24 h postoperative period in each group was P 33%; O 11%, A 9% and C 6%. Outcomes for all intervention groups were significantly better than that for placebo (p18 years, were eligible if scheduled to undergo a laparoscopy procedure (eg, gynaecological laparoscopic surgery or laparoscopic cholecystectomy). Patients were excluded31–33 if they had vomited or retched within 24 h before surgery, had taken an antiemetic, glucocorticosteroid or psychoactive drug within 24 h before the surgery, had an implanted cardiac pacemaker or defibrillator, had had their surgical technique changed, had any infectious disease within 2 weeks before surgery, had local infection near acupuncture points, or were pregnant or had menstrual symptoms, or were allergic to
Figure 1
vitamin B1. After giving written, informed consent, 160 patients were finally included in this study (see below). In view of the considerable impact of gender on POV, volunteers were stratified by gender. Thirty-two men and 128 women were allocated to four groups by simple randomisation, using computer-generated random numbers, concealed until the patient entered the postanaesthesia care unit (PACU). 1. Group P ( placebo-control group) : intravenous normal saline (4 mL)+bilateral injection of vitamin B1 into nonacupuncture point (100 mg:2 mL)/side (n=40). 2. Group O (ondansetron group): intravenous ondansetron (8 mg:4 mL)+bilateral ST36 sham injection: the needle touched the skin but no injection was given (n=40). 3. Group A (acustimulation group): intravenous normal saline (4 mL)+bilateral acupuncture point injection at ST36 of vitamin B1 (100 mg:2 mL)/side (n=40). 4. Group C (combination group): intravenous ondansetron +bilateral acupuncture point injection at ST36 of vitamin B1 (100 mg:2 mL)/side (n=40).
Detailed medical histories and demographic information were obtained from each patient. Finger-cun (eg, 1.0 and 3.0 cun) were measured and recorded in advance before the patient entered the operating room. ST36 is located 3.0 cun inferior to the lateral depression underneath the patellar ligament, and one middlefinger breadth lateral to the tibial crest (figure 1A). A standardised anaesthesia regimen was used. Phenobarbital sodium (0.1 g intrasmuscular) and atropine (0.5 mg intrasmuscular) were administered for premedication half an hour before entering the operating theatre. Standard monitors were used during the intraoperative period to measure pulse oxygen saturation, heart rate, blood pressure and end-tidal CO2 gas tension. Anaesthesia was induced with midazolam (0.06–0.10 mg/kg intravenous (IV)), fentanyl (0.004– 0.008 mg/kg IV), cisatracurium (0.15–0.20 mg/kg IV) and etomidate (0.20–0.40 mg/kg IV). Anaesthesia was maintained with propofol (4–8 mg/kg/h IV), sevoflurane (0.8–2%, inspired concentration) and
(A) Location of ST36 and the non-acupuncture point. (B) Dressing over ST36 and the non-acupuncture point.
Chen ZY, et al. Acupunct Med 2014;32:124–131. doi:10.1136/acupmed-2013-010340
125
Downloaded from http://aim.bmj.com/ on November 28, 2015 - Published by group.bmj.com
Original paper atracurium (5 mg/kg/h IV) after endotracheal intubation. The pneumoperitoneum pressure range was set to 14– 16 mm Hg. After induction of anaesthesia, levobupivacaine 0.25% (3 mL per incision, a total of 9 mL per patient) was infiltrated in all patients before skin incisions for trocar insertion. Opioid analgesics were also standardised perioperatively. If needed, supplemental bolus doses of fentanyl (0.002 mg/kg IV) were given for intraoperative analgesia. All patients received flurbiprofen (50 mg IV, for >1 min) at the end of surgery. Premedication, intraoperative anaesthetics, the duration of anaesthesia and surgery were documented, the duration of carbon dioxide (CO2) pneumoperitoneum,34 consumption of fentanyl,2 25 35 propofol and sevoflurane,36–38 which may influence the outcomes, were also documented. On arrival in the PACU, patients received either normal saline (4 mL IV)—groups P and A, or, ondansetron (8 mg:4 mL IV)—groups O and C, from a nurse using identical-appearing syringes, and underwent standardised acupuncture. Bilateral acupuncture point injection at ST36 was carried out using vitamin B1 injection. The bilateral non-acupuncture point injection of vitamin B1 was given 1.0 cun lateral to ST36 (figure 1A). The ST36 and non-acupuncture points of all patients were covered with adhesive tapes, 5×5 cm2, to blind both patients and investigators (figure 1B). Acupuncture was performed by a licensed acupuncture practitioner, following a standardised protocol complying with the basic principles of the Clean Needle Technique Manual for Acupuncturists,14 39 40 using one sterile, disposable 5 mL syringe ( Jie Rui, Shandong, P. R. China), with a stainless-steel needle (diameter 0.7 mm), and vitamin B1 injection solution (Tian Wu, Tianjin, P. R. China) 2 mL (100 mg). Acupuncture points were prepared with iodine. The needle with syringe was inserted perpendicularly at the ST36 point (groups C and A) or non-acupuncture point (group P). When the needle reached a depth of about 1.0–1.5 cun, and at the point where the acupuncturist normally would obtain the ‘de qi sensation’, the syringe piston was withdrawn to ensure that the needle did not penetrate blood vessels. At this point 2 mL vitamin B1 was injected, the needle was pulled out, and pressure exerted over the injection site for 3 min with a disinfectant swab. When it was clear that there was no bleeding, the site was covered with adhesive tape until the final assessment. The residual neuromuscular blockade was reversed with a combination of neostigmine (0.02 mg/ kg IV) and atropine (0.01 mg/kg IV). Patients were observed for 24 h in PACU and wards by an observer who was blinded to the research design. Any adverse events occurring during the acupuncture point injection were also recorded carefully. Patients, anaesthetists, surgical, nursing staff and our follow-up investigators were all blinded to the group 126
allocation. The investigator responsible for collecting data was also unaware of the treatments assigned. Evaluation of study endpoints
The primary outcome was the incidence of POV among the groups within 24 h after the operation, checked at predetermined intervals,30 and expressed as a percentage. The definition of vomiting in this study was ejection of the stomach contents up to, or out of, the mouth, including retching, laboured contractions of the abdominal wall muscles without the expulsion of gastric content. The severity of POV was classified by the number of episodes during a given observation period as follows: 0=none, 1=mild (one or two times), 2=moderate (three or four times), and 3=severe (five or more times). For overall evaluation of treatment efficacy, we used the 24 h total count of patients with vomiting of any severity. This 24 h total count for vomiting was transformed into the count for non-vomiting and was used for calculation of the OR and number needed to treat (NNT). Secondary outcomes included (1) incidence of rescue antiemetic drug use; (2) patients’ satisfaction with POV management; (3) time for the first anal exsufflation; (4) incidence of adverse reactions associated with acupuncture, 24 h after the operation. Any patient who vomited, or who requested a rescue antiemetic drug (when they had severe nausea) in the PACU or the ward, was given IV droperidol 0.625 mg at the first rescue, IV dexamethasone 4 mg at the second rescue and ondansetron 1 mg at the third rescue, if needed. Any patient who had excruciating pain after surgery received an IM injection of 100 mg tramadol as rescue analgesia therapy. Patients’ consent was needed for any remedial treatment. At 24 h after surgery, the anal exsufflation time was evaluated. Patients were also asked whether they had any unpleasant sensation associated with their leg. Their satisfaction with POV management was assessed on a five-point rating scale: 0=very unsatisfied; 1=unsatisfied, 2=normal, 3=satisfied, 4=very satisfied. Statistical analysis
Data were analysed with SPSS V.13.0 for Windows. All continuous variables are presented as means±SD, numbers or percentages, and analysed by one-way analysis of variance, with the least significant difference (LSD) or Student–Newman–Keuls test performed for post hoc multiple comparisons when equal variances were assumed; or by the Kruskal–Wallis test when equal variances were not assumed. Categorical data were analysed using the χ2 and the Kruskal–Wallis tests. A value of p
