Intraoperative Wound Infiltration With Bupivacaine in Patients Undergoing Elective Cholecystectomy Jos J. A. M.
van
Raay, MD; Jan
A.
Roukema, MD, PhD; Bertil
double-blind randomized trial, 50 patients scheduled for elective cholecystectomy received 50 mL of either \s=b\ In a
0.25% bupivacaine hydrochloride or physiologic saline by wound perfusion at the end of the operation before wound closure. The duration of incisional infiltration, total amount of postoperative analgesics administered, and total hospital stay were recorded. Pulmonary function tests were performed the day before surgery and 1 day after surgery. There was no difference between the two groups with regard to duration of analgesia, the amount of analgesics administered, or the total hospital stay. Both groups also had similar decrements in forced vital capacity and forced expiratory volume on the first postoperative day. We conclude that wound infiltration with 0.25% bupivacaine after elective cholecystectomy is not effective in reducing postoperative pain. Lung function disturbances cannot be prevented.
(Arch Surg. 1992;127:457-459)
anal¬
problem of providing adequate postoperative The gesia persists despite progress modern surgery and anesthesia. Effective management of postoperative in
pain depends on patient demand, ofinstruction of medical staff, and attitude and availability nursing staff as well as a suitable analgesic agent. Intramuscular injections of narcotic analgesics have many drawbacks. Requirements of opioids correlate poorly with the patient's age, weight, and type of operation. Narcotic analgesics provide good including pain relief but can elicit unwanted side effects,reflex.1 cough respiratory depression and decreased The serum level of opioids rises and falls dramatically during a 4-hour period, with correspondingInperiods of addition, drowsiness, pain, and, at times, nausea. there are the undesirable effects of opioid drugs on intes¬ tinal motility and the tendency to cause vomiting. The introduction of long-acting local anesthetic drugs, such as bupivacaine hydrochloride, has led to a renewed interest in these agents for local wound perfusion. Infil¬ tration of bupivacaine into surgical wounds has been re¬ after her¬ ported to provide good postoperative analgesia nia repair and upper abdominal surgery with a decrease Accepted
for
publication
November 2, 1991.
Department of Surgery, St Elisabeth Hospital, Tilburg. Reprint requests to the Department of Surgery, St Elisabeth HosFrom the
pital Tilburg, Roukema).
PO Box 90151, 5000 LC
Tilburg, the
Netherlands (Dr
W.
Lenderink, PharmD
pulmonary complications.2"6 Controversy exists as to the efficacy of bupivacaine wound perfusion in the relief of postoperative pain or pulmonary complications.7"9 Although some studies suggest that wound perfusion with bupivacaine provides effective pain relief with a concomitant reduction in opioid requirements, other in¬ vestigators have found saline wound perfusion to be equally effective, perhaps because of the removal or dilu¬ tion of pain-mediating substances.10 A double-blind trial was designed to assess the effects of intraoperative wound infiltration of bupivacaine in patients undergoing elective cholecystectomy with regard to postoperative pain relief, pulmonary function, and total hospital stay.
in
PATIENTS AND METHODS Before admission to the study, all patients were informed about the aims, methods, anticipated benefits, and potential hazards of the study. Patients were notified that they were free to withdraw from the study at any time. A written consent to participate in the study was obtained from each patient prior to admission into the study. All patients between the ages of 20 and 70 years scheduled for elective cholecystectomy were eligible for inclusion. Patients with a history of allergy, sensitivity, or any other form of reac¬ tion to local anesthetics of the amide type were excluded. Patients were randomly allocated to receive wound infiltration of either bupivacaine or plain saline. Surgical treatment was the same in the two groups. Efficacy variables included duration of analgesia, total hospital stay, and change in the forced expiratory volume in 1 second (FEV^ and forced vital capacity (FVC). All patients received general anesthesia with trachéal intuba¬ tion. Cholecystectomy was performed through an upper midline incision. At closure of the surgical wound, a 50-mL solution containing 125 mg of 0.25% bupivacaine hydrochloride or plain saline (according to the randomization list) was infiltrated into the cut surfaces of the peritoneum, fascia, subcutis, and dermis. The duration of complete analgesia was defined as the time be¬ tween the incisional infiltration and the time when the patient first required analgesic treatment after surgery. Ten milligrams of nicomorphine (Vilan) was administered subcutaneously or 50 mg of diclofenac sodium (Voltaren R) was administered in suppository form on patients' request during the first 48 hours after surgery. After 48 hours, only diclofenac was administered. The time of administration and dose of analgesic administered were recorded. Pulmonary function tests were also performed the day before and after surgery. All spirometrie tests were performed with the patient in a sitting position. The test was performed three times and the highest value was recorded. The FVC and FEV, were re-
Downloaded From: http://archsurg.jamanetwork.com/ by a Penn State Milton S Hershey Med Ctr User on 05/26/2015
Fig 1. Preoperative and postoperative pulmonary function test re¬ sults in the bupivacaine vs placebo groups. FVC indicates forced vi¬ tal capacity; and FEV,, forced expiratory volume in 1 second.
Fig 2.—Additional analgesics administered after surgery. ative day 0 indicates the day of surgery.
Postoper¬
—
higher in
however, corded the day before surgery and 24 hours after surgery. Parameters to compare the similarity between the two treatment groups were analyzed with Wilcoxon's rank sum test. The Mann-Whitney two-tailed test was used to analyze treatment results. A P
van
Raay, MD; Jan
A.
Roukema, MD, PhD; Bertil
double-blind randomized trial, 50 patients scheduled for elective cholecystectomy received 50 mL of either \s=b\ In a
0.25% bupivacaine hydrochloride or physiologic saline by wound perfusion at the end of the operation before wound closure. The duration of incisional infiltration, total amount of postoperative analgesics administered, and total hospital stay were recorded. Pulmonary function tests were performed the day before surgery and 1 day after surgery. There was no difference between the two groups with regard to duration of analgesia, the amount of analgesics administered, or the total hospital stay. Both groups also had similar decrements in forced vital capacity and forced expiratory volume on the first postoperative day. We conclude that wound infiltration with 0.25% bupivacaine after elective cholecystectomy is not effective in reducing postoperative pain. Lung function disturbances cannot be prevented.
(Arch Surg. 1992;127:457-459)
anal¬
problem of providing adequate postoperative The gesia persists despite progress modern surgery and anesthesia. Effective management of postoperative in
pain depends on patient demand, ofinstruction of medical staff, and attitude and availability nursing staff as well as a suitable analgesic agent. Intramuscular injections of narcotic analgesics have many drawbacks. Requirements of opioids correlate poorly with the patient's age, weight, and type of operation. Narcotic analgesics provide good including pain relief but can elicit unwanted side effects,reflex.1 cough respiratory depression and decreased The serum level of opioids rises and falls dramatically during a 4-hour period, with correspondingInperiods of addition, drowsiness, pain, and, at times, nausea. there are the undesirable effects of opioid drugs on intes¬ tinal motility and the tendency to cause vomiting. The introduction of long-acting local anesthetic drugs, such as bupivacaine hydrochloride, has led to a renewed interest in these agents for local wound perfusion. Infil¬ tration of bupivacaine into surgical wounds has been re¬ after her¬ ported to provide good postoperative analgesia nia repair and upper abdominal surgery with a decrease Accepted
for
publication
November 2, 1991.
Department of Surgery, St Elisabeth Hospital, Tilburg. Reprint requests to the Department of Surgery, St Elisabeth HosFrom the
pital Tilburg, Roukema).
PO Box 90151, 5000 LC
Tilburg, the
Netherlands (Dr
W.
Lenderink, PharmD
pulmonary complications.2"6 Controversy exists as to the efficacy of bupivacaine wound perfusion in the relief of postoperative pain or pulmonary complications.7"9 Although some studies suggest that wound perfusion with bupivacaine provides effective pain relief with a concomitant reduction in opioid requirements, other in¬ vestigators have found saline wound perfusion to be equally effective, perhaps because of the removal or dilu¬ tion of pain-mediating substances.10 A double-blind trial was designed to assess the effects of intraoperative wound infiltration of bupivacaine in patients undergoing elective cholecystectomy with regard to postoperative pain relief, pulmonary function, and total hospital stay.
in
PATIENTS AND METHODS Before admission to the study, all patients were informed about the aims, methods, anticipated benefits, and potential hazards of the study. Patients were notified that they were free to withdraw from the study at any time. A written consent to participate in the study was obtained from each patient prior to admission into the study. All patients between the ages of 20 and 70 years scheduled for elective cholecystectomy were eligible for inclusion. Patients with a history of allergy, sensitivity, or any other form of reac¬ tion to local anesthetics of the amide type were excluded. Patients were randomly allocated to receive wound infiltration of either bupivacaine or plain saline. Surgical treatment was the same in the two groups. Efficacy variables included duration of analgesia, total hospital stay, and change in the forced expiratory volume in 1 second (FEV^ and forced vital capacity (FVC). All patients received general anesthesia with trachéal intuba¬ tion. Cholecystectomy was performed through an upper midline incision. At closure of the surgical wound, a 50-mL solution containing 125 mg of 0.25% bupivacaine hydrochloride or plain saline (according to the randomization list) was infiltrated into the cut surfaces of the peritoneum, fascia, subcutis, and dermis. The duration of complete analgesia was defined as the time be¬ tween the incisional infiltration and the time when the patient first required analgesic treatment after surgery. Ten milligrams of nicomorphine (Vilan) was administered subcutaneously or 50 mg of diclofenac sodium (Voltaren R) was administered in suppository form on patients' request during the first 48 hours after surgery. After 48 hours, only diclofenac was administered. The time of administration and dose of analgesic administered were recorded. Pulmonary function tests were also performed the day before and after surgery. All spirometrie tests were performed with the patient in a sitting position. The test was performed three times and the highest value was recorded. The FVC and FEV, were re-
Downloaded From: http://archsurg.jamanetwork.com/ by a Penn State Milton S Hershey Med Ctr User on 05/26/2015
Fig 1. Preoperative and postoperative pulmonary function test re¬ sults in the bupivacaine vs placebo groups. FVC indicates forced vi¬ tal capacity; and FEV,, forced expiratory volume in 1 second.
Fig 2.—Additional analgesics administered after surgery. ative day 0 indicates the day of surgery.
Postoper¬
—
higher in
however, corded the day before surgery and 24 hours after surgery. Parameters to compare the similarity between the two treatment groups were analyzed with Wilcoxon's rank sum test. The Mann-Whitney two-tailed test was used to analyze treatment results. A P
