Breast Cancer Clinical Trial
Official title:
Liposomal Bupivacaine vs Bupivacaine With Dexmedetomidine in an Erector Spinae Plane Block for Mastectomies in Cancer Patients: A Randomized Control Trial
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | July 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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United States Naval Medical Center, Portsmouth |
Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15. — View Citation
Albrecht E, Vorobeichik L, Jacot-Guillarmod A, Fournier N, Abdallah FW. Dexamethasone Is Superior to Dexmedetomidine as a Perineural Adjunct for Supraclavicular Brachial Plexus Block: Systematic Review and Indirect Meta-analysis. Anesth Analg. 2019 Mar;128(3):543-554. doi: 10.1213/ANE.0000000000003860. — View Citation
Brown 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. — View Citation
Fidkowski 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. — View Citation
Haddock 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. — View Citation
Kim DH, Liu J, Beathe JC, Lin Y, Wetmore DS, Kim SJ, Haskins SC, Garvin S, Oxendine JA, Ho MC, Allen AA, Popovic M, Gbaje E, Wu CL, Memtsoudis SG. Interscalene Brachial Plexus Block with Liposomal Bupivacaine versus Standard Bupivacaine with Perineural Dexamethasone: A Noninferiority Trial. Anesthesiology. 2022 Mar 1;136(3):434-447. doi: 10.1097/ALN.0000000000004111. Erratum In: Anesthesiology. 2023 Feb 1;138(2):233. — View Citation
Leong 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. — View Citation
Malan 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. — View Citation
Nguyen A, Grape S, Gobbetti M, Albrecht E. The postoperative analgesic efficacy of liposomal bupivacaine versus long-acting local anaesthetics for peripheral nerve and field blocks: A systematic review and meta-analysis, with trial sequential analysis. Eur J Anaesthesiol. 2023 Sep 1;40(9):624-635. doi: 10.1097/EJA.0000000000001833. Epub 2023 Apr 10. — View Citation
Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2. — View Citation
Schnabel 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. Erratum In: Br J Anaesth. 2013 Sep;111(3):522. — View Citation
Siegel 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time to first opioid administration | Determine if there is a difference in time to first opioid dose after surgery when block is provided before surgery. To determine if there is a difference in the quality of the block after the surgery requiring earlier administration of opioids, as is expected with less dense block having more increased pain. | 24 hours | |
Primary | Is bupivacaine with dexmedetomidine superior to liposomal bupivacaine in both density and duration? | Control group erector spinae plane block with liposomal bupivacaine is less dense and not as long lasting as bupivacaine with dexmedetomidine experimental group. Will investigate initial VAS pain scores to determine how effective the block is after surgery and every 6 hours while in patient. Additionally, calling the patient discharging after 96 hours from the time of the block and collect daily pain scores from the patient. This is to establish which group had best pain scores throughout and longest duration of lowest pain scores. | 96 hours | |
Secondary | Evaluate oral milligram of morphine equivalent. | Same control and experimental group assessing for MME reduction between groups. Will investigate milligram of morphine equivalent every 6 hours to see how much each group requires. In particular looking for increasing trend in morphine equivalence over time. Additionally, calling the patient discharging after 96 hours from the time of the block and collect daily opioid medications taken by the patient and converting to milligram morphine equivalents. This is to establish which group has taken the least amount of morphine equivalents throughout the duration of the block, as an indication to the duration of optimum benefit of the block. | 96 hours |
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