Clinical trial · Interventional
Pain Management Following TRAM Flap for Breast Reconstruction
Randomized, Double Blind, Controlled Trial of Two Methods of Postoperative Pain Management Following Free Transverse Rectus Abdominous Musculocutaneous (TRAM) Flap for Breast Reconstruction
- 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)
The objective of this pilot study is to examine the efficacy of the ON\~Q Pain Relief System plus Intravenous Patient Controlled Analgesia (IVPCA) with Morphine vs IV PCA alone in patients undergoing free transverse rectus abdominis musculocutaneous (TRAM) flap surgery. The primary outcome measure will be postoperative opioid analgesia requirements. Other outcomes will also be assessed, including pain scores, quality of recovery, and resource utilization.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivicaine | Drug | — | UNRESOLVED |
| Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- On-Q pump with Saline
- description
- On-Q Pump with Saline
- interventionNames
- Drug: Saline
- type
- EXPERIMENTAL
- label
- On-Q Pump with Bupivicaine
- description
- On-Q Pump with bupivicaine
- interventionNames
- Drug: Bupivicaine
Primary outcomes (1)
- measure
- Total Postoperative Opioid Use by Patient
- timeFrame
- Measurements performed and recorded every 6 hours while patient is hospitalized.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with or undergoing unilateral elective free TRAM flap for breast reconstruction, immediate or delayed, with or without a surgical revision of the contralateral breast for asymmetry. * American Society of Anesthesiology Physical Status I - III patients. * Patients has given voluntary written informed consent before performance of any study-related procedure. Exclusion Criteria: * Patients undergoing bilateral TRAM flap reconstruction. * Patients with a prior allergic reaction to Marcaine (bupivacaine) or other amide local anesthetics. * Patients with a prior allergic reaction to Morphine and Hydromorphone. * Patients undergoing any other unrelated surgical procedure to the breast reconstruction. * Patient refusal to participate. * Patient required major abdominal surgery within four weeks prior to enrollment. * Patients being treated for chronic pain or using daily intake of opioid analgesics. * Patients with a history of abuse of recreational drugs or alcohol. * Patients with any laboratory values or underlying disease, which in the investigator's opinion would preclude them from participation in the trial, specifically: (A) significant liver dysfunction (eg. bilirubin, AST and/or ALT \>1.5 times the upper limit of normal value (B) cardiac conduction defects noted by history or on the pre-op screening EKG. * Pregnant or breast feeding.
References
Publications (0)
Data not yet available