Clinical trial · Interventional
Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies
Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in an Erector Spinae Plane Block for Mastectomies in Cancer Patients: a Randomized Control Trial
NCT06252662CI-TRIAL-00082671recruitingPhase 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)
Perform a comparison of effective pain relief duration between liposomal bupivacaine and dexmedetomidine when added to bupivacaine in a block for mastectomy for cancer surgery. The erector spinae plane block is a well-established block that is utilized for post operative pain control for procedures performed on the soft tissue of the chest and chest wall as well as intrathoracic procedures. The goal is comparison of the effective duration of both study groups to determine if there is a significant difference in time and amount of post operative opioids required which admitted to hospital.
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 |
|---|---|---|---|
| Dexmedetomidine | Drug | — | UNRESOLVED |
| Liposomal bupivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Liposomal bupivacaine and bupivacaine plain erector spinae plane block
- description
- Erector spinae plane block performed on the surgical side (left, right or bilateral) as appropriate based on planned surgical consent. Utilizing ultrasound to see the fascial layers and guide the needle placement under direct visualization. Block will include 1.33% liposomal bupivacaine 10ml plus 0.25% bupivacaine plain 20 ml per side of the block.
- interventionNames
- Drug: Liposomal bupivacaine
- type
- EXPERIMENTAL
- label
- Bupivacaine plain with dexmedetomidine
- description
- Erector spinae plane block performed on the surgical side (left, right or bilateral) as appropriate based on planned surgical consent. Utilizing ultrasound to see the fascial layers and guide the needle placement under direct visualization. Block will include 0.25% bupivacaine plain 30 ml plus dexmedetomidine 0.5 mcg/kg per side of the block.
- interventionNames
- Drug: Dexmedetomidine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients requiring any variation of mastectomy with or without axillary lymph node dissection. * Patient agrees to a peripheral nerve block. * Patient agrees to be a study participant. * APS team believes a peripheral nerve block would be appropriate for the patient after reviewing medical/surgical history. * Surgeon agrees with the block plan by APS. Exclusion Criteria: * Patient declines a peripheral nerve block. * Patient declines to be a study participant. * APS team believes a peripheral nerve block is not clinically indicated. * Surgeon does not want a peripheral nerve block. * Patient has allergy to local anesthestic. * Patient has an active infection at the site of the peripheral nerve block. * Patient with pre-existing neural deficits along the distribution of the block. * Patient with coagulopathy. * Patient taking antithrombotic drugs outside the ASRA guidelines. * Patients weight is less that 50 kg due to concerns for local anesthetic toxicity syndrome.
References
Publications (12)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7. PMID 26742998
- BACKGROUNDHaddock NT, Garza R, Boyle CE, Liu Y, Teotia SS. Defining Enhanced Recovery Pathway with or without Liposomal Bupivacaine in DIEP Flap Breast Reconstruction. Plast Reconstr Surg. 2021 Nov 1;148(5):948-957. doi: 10.1097/PRS.0000000000008409. PMID 34705768
- BACKGROUNDSchnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14. PMID 20947592
- BACKGROUNDLeong RW, Tan ESJ, Wong SN, Tan KH, Liu CW. Efficacy of erector spinae plane block for analgesia in breast surgery: a systematic review and meta-analysis. Anaesthesia. 2021 Mar;76(3):404-413. doi: 10.1111/anae.15164. Epub 2020 Jul 1. PMID 32609389
- BACKGROUNDBrown CA, Ghanouni A, Williams R, Payne SH, Ghareeb PA. Safety and Efficacy of Liposomal Bupivacaine Supraclavicular Nerve Blocks in Open Treatment of Distal Radius Fractures: A Perioperative Pain Management Protocol. Ann Plast Surg. 2023 Jun 1;90(6S Suppl 4):S332-S336. doi: 10.1097/SAP.0000000000003464. Epub 2023 Jan 31. PMID 36752544
- BACKGROUNDMalan SH, Jaroszewski DE, Craner RC, Weis RA, Murray AW, Meinhardt JR, Girardo ME, Abdelrazek AS, Borah BJ, Dholakia R, Smith BB. Erector Spinae Plane Block With Liposomal Bupivacaine: Analgesic Adjunct in Adult Pectus Surgery. J Surg Res. 2023 Sep;289:171-181. doi: 10.1016/j.jss.2023.03.016. Epub 2023 Apr 28. PMID 37121043
- BACKGROUNDFidkowski CW, Choksi N, Alsaden MR. A randomized-controlled trial comparing liposomal bupivacaine, plain bupivacaine, and the mixture of liposomal bupivacaine and plain bupivacaine in transversus abdominus plane block for postoperative analgesia for open abdominal hysterectomies. Can J Anaesth. 2021 Jun;68(6):773-781. doi: 10.1007/s12630-020-01911-1. Epub 2021 Jan 11.