Enhanced Recovery After Laparoscopic Colorectal Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406765
• Other study ID #: Project 2805
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: October 7, 2022

Study information

• Verified date: May 2022
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria *All patients undergoing laparoscopic abdominoperineal rectal amputation for rectal cancer

• Age 18-100 years are eligible for enrollment in the study. Exclusion Criteria
• ASA IV,
• BMI>35,
• contraindication to spinal analgesia
• allergy to any of the drugs used in this study protocol,
• chronic use of opioids or steroids,
• liver or renal impairment,
• patients scheduled for synchronous laparoscopic liver metastatic surgery
• inability to communicate in Norwegian.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Rectal Cancer

Intervention

Drug:
• Bupivacaine Injection
One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø	Troms

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nummeric rating scale (0-10), where 10 indicate worst possible pain.	Worst pain scores in the first 48 hrs.	48 hours after surgery