- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05406765
Enhanced Recovery After Laparoscopic Colorectal Surgery
December 21, 2022 updated by: University Hospital of North Norway
Spinal Analgesia for Laparoscopic Abdominoperineal Rectal Amputation Using an Enhanced Recovery After Surgery Program: a Randomized Double-blind Placebo-controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Troms
-
Tromsø, Troms, Norway, 9038
- University Hospital of North Norway
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 98 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Spinal
Spinal anesthesia
|
One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally
Other Names:
|
Placebo Comparator: Placebo
Placebo spinal
|
One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lars M Ytrebø, PhD, University Hospital of North Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
October 7, 2022
Study Completion (Actual)
October 7, 2022
Study Registration Dates
First Submitted
June 1, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (Actual)
June 6, 2022
Study Record Updates
Last Update Posted (Estimate)
December 22, 2022
Last Update Submitted That Met QC Criteria
December 21, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Project 2805
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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