Enhanced Recovery After Laparoscopic Colorectal Surgery

Phase 4

Completed

• Conditions: Postoperative Pain; Rectal Cancer
• Interventions: Drug: Bupivacaine Injection

• Registration Number: NCT05406765
• Lead Sponsor: University Hospital of North Norway

Brief Summary

Investigators would like to test the effects of spinal anesthesia as an adjunct to general anesthesia in patients undergoing laparoscopic abdominoperineal rectal amputation. Investigators hypothesize that spinal anesthesia as an adjunct to general anesthesia will reduce postoperative pain and opioid requirements.

Detailed Description

Effective pain management after laparoscopic rectal surgery is a fundamental requirement in an enhanced recovery after surgery program (ERAS). Opioids remain the mainstay for postsurgical pain despite well documented side effects including sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression. Spinal analgesia as an adjunct to general anesthesia has not been studied in laparoscopic rectal surgery, but data from studies of patients undergoing colon cancer resection indicate a positive analgesic effect of spinal anesthesia as an adjunct to general anesthesia. When an ERAS program was used for laparoscopic colonic resection, It has been showed that an intrathecal mixture of bupivacaine and morphine was associated with less postoperative opioid consumption. In a more recent paper intrathecal morphine was a more effective method for treating postoperative pain in laparoscopic colon surgery than intravenous opioids within an ERAS program. In the present proposal the investigators would like to test the effects of spinal anesthesia as an adjunct to general anesthesia in patients undergoing laparoscopic abdominoperineal rectal amputation. It was hypothesized that spinal anesthesia as an adjunct to general anesthesia would reduce postoperative pain and opioid requirements.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-05
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal	Bupivacaine Injection	Spinal anesthesia
Placebo	Bupivacaine Injection	Placebo spinal

Primary Outcome Measures

Name	Time	Method
Nummeric rating scale (0-10), where 10 indicate worst possible pain.	48 hours after surgery	Worst pain scores in the first 48 hrs.

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsø, Troms, Norway