Enhanced Recovery After Laparoscopic Colorectal Surgery
Primary Purpose
Rectal Cancer, Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Bupivacaine Injection
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
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.
Sites / Locations
- University Hospital of North Norway
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Spinal
Placebo
Arm Description
Spinal anesthesia
Placebo spinal
Outcomes
Primary Outcome Measures
Nummeric rating scale (0-10), where 10 indicate worst possible pain.
Worst pain scores in the first 48 hrs.
Secondary Outcome Measures
Full Information
NCT ID
NCT05406765
First Posted
June 1, 2022
Last Updated
December 21, 2022
Sponsor
University Hospital of North Norway
1. Study Identification
Unique Protocol Identification Number
NCT05406765
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization, allocation, and blinding: Randomization will be conducted by using sealed, opaque envelopes. An independent colleague at the Clinical Research Department will randomize these envelopes in blocks of 5. These envelopes will be stacked and stored outside the operating room. The upper envelope will be opened by the attending anesthesiologist when an included patient arrives in the operating theater. The patient, surgical team, nurses on the ward, and researcher team will be blinded. Only the attending anesthetic team will be aware of the randomization. They will be instructed not to tell the patient or any other health care worker which group the patient was allocated to.
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal
Arm Type
Active Comparator
Arm Description
Spinal anesthesia
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo spinal
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Other Intervention Name(s)
Marcain
Intervention Description
One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally
Primary Outcome Measure Information:
Title
Nummeric rating scale (0-10), where 10 indicate worst possible pain.
Description
Worst pain scores in the first 48 hrs.
Time Frame
48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars M Ytrebø, PhD
Organizational Affiliation
University Hospital of North Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromsø
State/Province
Troms
ZIP/Postal Code
9038
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Enhanced Recovery After Laparoscopic Colorectal Surgery
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