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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal | Active Comparator | Spinal anesthesia |
|
| Placebo | Placebo Comparator | Placebo spinal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Injection | Drug | One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nummeric rating scale (0-10), where 10 indicate worst possible pain. | Worst pain scores in the first 48 hrs. | 48 hours after surgery |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Lars M Ytrebø, PhD | University Hospital of North Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of North Norway | Tromsø | Troms | 9038 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37284327 | Derived | Antunes M, Baumgartel A, Gjessing PF, Ytrebo LM. Spinal Anaesthesia as an Adjunct to General Anaesthesia for Laparoscopic Abdominoperineal Rectal Amputation. J Pain Res. 2023 May 31;16:1855-1865. doi: 10.2147/JPR.S410019. eCollection 2023. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |