Clinical trial · Interventional
Enhanced Recovery After Laparoscopic Colorectal Surgery
Spinal Analgesia for Laparoscopic Abdominoperineal Rectal Amputation Using an Enhanced Recovery After Surgery Program: a Randomized Double-blind Placebo-controlled Trial
NCT05406765CI-TRIAL-00062841completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Pain | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Spinal
- description
- Spinal anesthesia
- interventionNames
- Drug: Bupivacaine Injection
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo spinal
- interventionNames
- Drug: Bupivacaine Injection
Primary outcomes (1)
- measure
- Nummeric rating scale (0-10), where 10 indicate worst possible pain.
- timeFrame
- 48 hours after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAntunes 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. PMID 37284327