LapChole: RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy

Sponsor

Klinicki Centar Vojvodine (Other)

Overall Status

Completed

CT.gov ID

NCT01972620

Collaborator

(none)

Enrollment

Location

Arms

3.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. Topical cystic plate and port-site incision 0.25% bupivacaine significantly reduces pain after laparoscopic cholecystectomy.

Condition or Disease	Intervention/Treatment	Phase
Gallstones Cholelithiasis Pain	Drug: Bupivacaine	N/A

Detailed Description

Background: Peri-portal nerve stimulation has recently been suggested as a mechanism for pain after laparoscopic cholecystectomy (LapChole). We therefore conducted a PRCT to evaluate whether somatovisceral pain blockade reduces pain after LapChole.

Hypothesis:Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective LapChole for symptomatic cholelithiasis. Specifically, topical cystic plate and port-site infiltrationwith0.25% bupivacaine significantly reduces pain after LapChole.

Design: Single-blinded PRCT Setting: Academic medical centers Patients and Methods: Between February and May 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to institutional standard non-opioid/opioid analgesic combinations (n=32), and institutional standard analgesia plus topical 0.25%bupivacaine spray onto the cystic plate and local 0.25% bupivacaine port-site injection,post-LapChole (n=31). Primary endpoint was patient-reported pain 1, 4, 6, 12, and 24 hours, and 1 week post-LapCholeusing the Visual Acuity Score (VAS, 0-10).

Results: Study groups were comparable clinicopathologically. There were no study-procedure-associated adverse events. A statistically significant reduction in mean pain score was apparent in patients receiving multi-modal analgesia at all early (1-6 hours) post-operative time points and at one week following LapChole(p<0.05).

Conclusion: This PRCT shows significantly improved pain reduction with somatovisceral pain blockade than institutional standard analgesic combinations following LapChole for symptomatic cholelithiasis. For centers not utilizing adjunctive local anesthetic for this operation, this multi-modal analgesic approach can improve patient comfort during recovery.This approach serves as the basis for a planned 4-arm PRCT designed to provide further insights into the role of local anesthetics in multi-modal operative site analgesia.

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Prospective Randomized Controlled Trial (PRCT) Comparing Standard Analgesia With Multi-modal Targeted Operative and Port-Site Local Anesthesia for Post-Operative Pain Management in Elective Laparoscopic Cholecystectomy (LapChole)

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Multi-modal analgesia Thirty-one patients were enrolled in this arm. Standard analgesia according to institutional standard and 50:50 mixture of normal saline (8 ml) and 0.5% Bupivacaine was prepared within a 20 ml syringe (Total volume = 16 ml; Final concentration = 0.25%). Following delivery of the gallbladder specimen 8 ml of 0.25% bupivacaine solution was sprayed onto the cystic plate (gallbladder fossa) with a spinal needle advanced under direct laparoscopic vision via a 5mm right subcostal laparoscopic port. The anesthetic solution was sprayed at an operating distance from the cystic plate of ~ 2 cm. Following evacuation of the pneumoperitoneum, the remaining 8 ml of 0.25% Bupivacaine was infiltrated subcutaneously at each of the 4 laparoscopic port sites (2 ml per port site) prior sutured closure.	Drug: Bupivacaine A 50:50 mixture of normal saline (8 ml) and 0.5% Bupivacaine was prepared within a 20 ml syringe (Total volume 16 ml; Final concentration = 0.25%). Following delivery of the gallbladder specimen in the Multi-modal analgesia group, 8 ml of 0.25% bupivacaine solution was sprayed onto the cystic plate (gallbladder fossa) with a spinal needle advanced under direct laparoscopic vision via a 5mm right subcostal laparoscopic port. The anesthetic solution was sprayed at an operating distance from the cystic plate of ~ 2 cm. Following evacuation of the pneumoperitoneum, again within the Multi-modal analgesia group, the remaining 8 ml of 0.25% Bupivacaine was infiltrated subcutaneously at each of the four laparoscopic port sites (2 ml per port site) prior to standard sutured closure of each incision Other Names: Marcaine Bupivacaine HCL
No Intervention: Control Thirty-two patients were enrolled in this arm. They received standard analgesia according to institutional standard of practice consisted of non-narcotic analgesia with narcotic analgesic rescue after laparoscopic cholecystectomy.

Arm

Intervention/Treatment

Active Comparator: Multi-modal analgesia

Thirty-one patients were enrolled in this arm. Standard analgesia according to institutional standard and 50:50 mixture of normal saline (8 ml) and 0.5% Bupivacaine was prepared within a 20 ml syringe (Total volume = 16 ml; Final concentration = 0.25%). Following delivery of the gallbladder specimen 8 ml of 0.25% bupivacaine solution was sprayed onto the cystic plate (gallbladder fossa) with a spinal needle advanced under direct laparoscopic vision via a 5mm right subcostal laparoscopic port. The anesthetic solution was sprayed at an operating distance from the cystic plate of ~ 2 cm. Following evacuation of the pneumoperitoneum, the remaining 8 ml of 0.25% Bupivacaine was infiltrated subcutaneously at each of the 4 laparoscopic port sites (2 ml per port site) prior sutured closure.

Drug: Bupivacaine

A 50:50 mixture of normal saline (8 ml) and 0.5% Bupivacaine was prepared within a 20 ml syringe (Total volume 16 ml; Final concentration = 0.25%). Following delivery of the gallbladder specimen in the Multi-modal analgesia group, 8 ml of 0.25% bupivacaine solution was sprayed onto the cystic plate (gallbladder fossa) with a spinal needle advanced under direct laparoscopic vision via a 5mm right subcostal laparoscopic port. The anesthetic solution was sprayed at an operating distance from the cystic plate of ~ 2 cm. Following evacuation of the pneumoperitoneum, again within the Multi-modal analgesia group, the remaining 8 ml of 0.25% Bupivacaine was infiltrated subcutaneously at each of the four laparoscopic port sites (2 ml per port site) prior to standard sutured closure of each incision

Other Names:

Marcaine

Bupivacaine HCL

No Intervention: Control

Thirty-two patients were enrolled in this arm. They received standard analgesia according to institutional standard of practice consisted of non-narcotic analgesia with narcotic analgesic rescue after laparoscopic cholecystectomy.

Outcome Measures

Primary Outcome Measures

Visual Scale Pain VAS [from 0 to 7 postoperative days]
The primary endpoint was patient-reported pain 1, 4, 6, 12, and 24 hours, and 7 days following laparoscopic cholecystectomy using the Visual Acuity Score (VAS, 0-10).

Secondary Outcome Measures

nausea [from 0 to 6 hours post-operatively]
Surgical outcome data recorded prospectively also included severity of post-operative nausea (measured VAS, 0 none and 10 worst state) on one and six hours post-operatively.

Other Outcome Measures

mobility [from 0 to 7 postoperative days]
Surgical outcome data recorded prospectively also included hospital stay (days), impairment of mobility [measured with VAS, 0 is worst and 10 optimal mobility (pre-operative baseline)] one and seven days post-operatively,

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

symptomatic cholelithiasis undergo elective laparoscopic cholecystectomy
non - pregnant women
18 years or older

Exclusion Criteria:

undergoing urgent cholecystectomy
patients operated on for indications other than symptomatic cholelithiasisT
those having conversion from laparoscopic to open cholecystectomy
those that withdrew from the study for any reason before the end of the required 7-day follow up (including those that died during that period)
those with incomplete data.