Clinical trial · Interventional
Efficacy of Perioperative Duloxetine as a Part of Multimodal Analgesia in Laparoscopic Colorectal Cancer Surgery
NCT04294953CI-TRIAL-00043804unknownPhase 2ClinicalTrials.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)
Our aim will be to evaluate the efficacy of perioperative Duloxetine in decreasing acute postoperative pain after laparoscopic colorectal cancer surgery and its role in reducing postoperative morphine requirements
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duloxetine | Drug | — | UNRESOLVED |
| Placebo oral tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group (I) (D) : (Duloxetine group)
- interventionNames
- Drug: Duloxetine
- type
- PLACEBO_COMPARATOR
- label
- Group (II) (P): (placebo group)
- interventionNames
- Drug: Placebo oral tablet
Primary outcomes (1)
- measure
- morphine consumption
- timeFrame
- 48 hours postoperative
- description
- total morphine consumption(mg) in 48 hours if VAS score( Visual Analog Scale ) more than 3. score from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * ASA I-III * aged 18-65 years and scheduled for laparoscopic colorectal surgery for cancer colon Exclusion Criteria: * unable to express their pain or patient refusal. * allergy to the study drug * an abnormal liver or renal function tests * a chronic opioid abuser(\> 3 mo), being on chronic gabapentin or pregabalin(\> 3 mo) * antidepressant drugs, patients with psychiatric disorders * Pregnant females
References
Publications (4)
- BACKGROUNDGovil N, Parag K, Arora P, Khandelwal H, Singh A; Ruchi. Perioperative duloxetine as part of a multimodal analgesia regime reduces postoperative pain in lumbar canal stenosis surgery: a randomized, triple blind, and placebo-controlled trial. Korean J Pain. 2020 Jan 1;33(1):40-47. doi: 10.3344/kjp.2020.33.1.40. PMID 31888316
- BACKGROUNDHo KY, Tay W, Yeo MC, Liu H, Yeo SJ, Chia SL, Lo NN. Duloxetine reduces morphine requirements after knee replacement surgery. Br J Anaesth. 2010 Sep;105(3):371-6. doi: 10.1093/bja/aeq158. Epub 2010 Jun 23. PMID 20573635
- BACKGROUNDTakmaz O, Bastu E, Ozbasli E, Gundogan S, Karabuk E, Kocyigit M, Dede S, Naki M, Kose F, Gungor M. Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy: A Randomized Placebo-Controlled Trial. J Minim Invasive Gynecol. 2020 Mar-Apr;27(3):665-672. doi: 10.1016/j.jmig.2019.04.028. Epub 2019 Aug 30. PMID 31476481
- BACKGROUNDAttia JZ, Mansour HS. Perioperative Duloxetine and Etoricoxibto improve postoperative pain after lumbar Laminectomy: a randomized, double-blind, controlled study. BMC Anesthesiol. 2017 Dec 2;17(1):162. doi: 10.1186/s12871-017-0450-z. PMID 29197345