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Clinical Trials/NCT05406765
NCT05406765
Completed
Phase 4

Spinal Analgesia for Laparoscopic Abdominoperineal Rectal Amputation Using an Enhanced Recovery After Surgery Program: a Randomized Double-blind Placebo-controlled Trial

University Hospital of North Norway1 site in 1 country10 target enrollmentJanuary 1, 2022

Overview

Phase
Phase 4
Intervention
Bupivacaine Injection
Conditions
Rectal Cancer
Sponsor
University Hospital of North Norway
Enrollment
10
Locations
1
Primary Endpoint
Nummeric rating scale (0-10), where 10 indicate worst possible pain.
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
October 7, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital of North Norway
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Spinal

Spinal anesthesia

Intervention: Bupivacaine Injection

Placebo

Placebo spinal

Intervention: Bupivacaine Injection

Outcomes

Primary Outcomes

Nummeric rating scale (0-10), where 10 indicate worst possible pain.

Time Frame: 48 hours after surgery

Worst pain scores in the first 48 hrs.

Study Sites (1)

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