Clinical trial NCT05406765: Enhanced Recovery After Laparoscopic Colorectal Surgery
Official title: Spinal Analgesia for Laparoscopic Abdominoperineal Rectal Amputation Using an Enhanced Recovery After Surgery Program: a Randomized Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rectal Cancer
Postoperative Pain
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nummeric rating scale (0-10), where 10 indicate worst possible pain.
timeFrame: 48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Lars M Ytrebø, PhD
role: PRINCIPAL_INVESTIGATOR
References: