Clinical trial · Interventional
Bupivacaine Plus Diclofenac Versus Bupivacaine Alone for Postoperative Pain Relief in Gynecologic Cancer Patients
Comparison of Bupivacaine Peritoneal Infiltration and Intramuscular Diclofenac Versus Bupivacaine Peritoneal Infiltration Alone for Postoperative Pain Relief in Gynecologic Cancer Patients Undergoing Open Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Diclofenac is no longer recommend for intramuscular administration by the Medical Council of Thailand
Summary
Brief summary (as posted)
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS).
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 |
|---|---|---|---|
| Post-operative Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diclofenac | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- diclofenac and bupivacaine group
- description
- Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.
- interventionNames
- Other: Diclofenac
- type
- PLACEBO_COMPARATOR
- label
- bupivacaine only group
- description
- Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum, divided in 10 sites before closure and a 3 mL of sterile water was intramuscularly injected immediately after complete the procedure.
- interventionNames
- Other: Diclofenac
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * gynecologic cancer patients ,i.e. cervical cancer, endometrial cancer, or ovarian tumor suspicious for malignancy * who has scheduled for operation via laparotomy route * Women who has ASA physical status I-II * All of the have age more than 20 years old * able to communicate in Thai * Women who agrees to participate in this study Exclusion Criteria: * patient who had emergency conditions - indication for emergency operation * intraoperative cardiac arrhythmia * operation purpose for only tumor biopsy * Women who have abnormal kidney function test (Cr \> 1.5) * Women with history of gastrointestinal bleeding * Women who take the antiplatelet or anticoagulant medications * Women with history of allergy to bupivacaine and NSAIDs * Women who cannot evaluated pain score
References
Publications (0)
Data not yet available