Regional Block for Post-mastectomy Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serratus-intercostal plane block, Erector spinae plane block, Dexmedetomidine Injection.
- Who it may be relevant to
- Registry conditions: Analgesia. Basic parameters: 21 years — 64 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dexmedetomidine as an Adjuvant to Bupivacaine for Serratus-Intercostal Versus Erector-Spinae Plane Block to Relieve Post-Mastectomy Pain
Overview
A large number of patients undergoing major surgical procedures for the management of breast cancer complain of acute and chronic postoperative pain. Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques, such as paravertebral block and thoracic epidural anaesthesia, have possible complications and technical difficulties. So, we will discuss adding dexmedetomidine as an adjuvant to bupivacaine for serratus-intercostal versus erector-spinae plane block to relieve post-mastectomy pain.
Detailed description
Current pain management encompasses regional anaesthetic techniques and systemic administration of analgesia with a synergetic effect on pain. Regional analgesic techniques improve perioperative pain control, reduce opioid consumption and side-effects. We will investigate whether adding dexmedetomidine to bupivacaine for the serratus-intercostal plane block or the erector-spinae plane block during breast surgery could provide better intraoperative and postoperative analgesia, delay the time to first analgesic request, and reduce intraoperative and postoperative analgesic consumption.
Interventions
- Procedure Serratus-intercostal plane block
The patients will receive an ultrasound-guided serratus-intercostal plane block after induction of anaesthesia, using 0.25% bupivacaine and 1 μg/kg dexmedetomidine. - Procedure Erector spinae plane block
The patients will receive an ultrasound-guided erector spinae plane block after induction of anaesthesia, using 0.25% bupivacaine and 1 μg/kg dexmedetomidine. - Drug Dexmedetomidine Injection
The local anaesthetic mixture will include 0.25% bupivacaine plus 1 μg/kg dexmedetomidine.
Primary outcome measures
- The total opioid consumption. [Time frame: The first 24 hours postoperative.]
Secondary outcome measures (3)
- Time of the first rescue analgesia [Time frame: The first 24 hours postoperative.]
- The static and dynamic visual analogue scale [Time frame: The first 24 hours postoperative.]
- Number of participants with procedure-related adverse events [Time frame: The first 24 hours postoperative.]
Eligibility criteria
Inclusion criteria
- Unilateral mastectomy operations.
- Body mass index less than 35 kg per square meter.
- American Society of Anesthesiologists physical status grade I-II.
Exclusion criteria
- Patient refusal.
- History of chronic pain therapy.
- Infection at the injection site.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Nyima T, Palta S, Saroa R, Kaushik R, Gombar S. Ultrasound-guided erector spinae plane block compared to serratus anterior muscle block for postoperative analgesia in modified radical mastectomy surgeries: A randomized control trial. Saudi J Anaesth. 2023 Jul-Sep;17(3):311-317. doi: 10.4103/sja.sja_716_22. Epub 2023 Jun 22. PMID 37601524
- Vanni G, Caiazza G, Materazzo M, Storti G, Pellicciaro M, Buonomo C, Natoli S, Fabbi E, Dauri M. Erector Spinae Plane Block Versus Serratus Plane Block in Breast Conserving Surgery: Alpha Randomized Controlled Trial. Anticancer Res. 2021 Nov;41(11):5667-5676. doi: 10.21873/anticanres.15383. PMID 34732440
- Villa G, Mandarano R, Scire-Calabrisotto C, Rizzelli V, Del Duca M, Montin DP, Paparella L, De Gaudio AR, Romagnoli S. Chronic pain after breast surgery: incidence, associated factors, and impact on quality of life, an observational prospective study. Perioper Med (Lond). 2021 Feb 24;10(1):6. doi: 10.1186/s13741-021-00176-6. PMID 33622393
Identifiers
NCT: NCT07683416 · Breast surgery analgesia