Clinical trial · Interventional
Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain
Role of Wound Installation With Bupivacaine Through Surgical Drains in Postoperative Analgesia in Modified Radical Mastectomy
NCT03799757CI-TRIAL-00036467completedPhase 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)
in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pain, Postoperative | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 40ml of 0.25% bupivacaine | Drug | — | UNRESOLVED |
| 40ml of 0.9% normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bupivacaine
- description
- The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
- interventionNames
- Drug: 40ml of 0.25% bupivacaine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group)
- interventionNames
- Drug: 40ml of 0.9% normal saline
Primary outcomes (3)
- measure
- Visual analogue pain score
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection Exclusion Criteria: 1. Male patients 2. Bilateral breast cancer. 3. Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse 4. Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection. 5. Patients with known psychological or mental problems. 6. Patients who were not exposed to axillary dissection
References
Publications (0)
Data not yet available
No reference posted for this study.