Postoperative Pain, Rectal Cancer
Conditions
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.
Interventions
DRUGBupivacaine Injection
One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally
Sponsors
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nummeric rating scale (0-10), where 10 indicate worst possible pain. | 48 hours after surgery | Worst pain scores in the first 48 hrs. |
Countries
Norway
Outcome results
None listed