Regional Block for Post-mastectomy Analgesia

Dexmedetomidine as an Adjuvant to Bupivacaine for Serratus-Intercostal Versus Erector-Spinae Plane Block to Relieve Post-Mastectomy Pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07683416

Enrollment

Registered

2026-07-06

Start date

2026-06-01

Completion date

2027-02-01

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Keywords

Analgesia, Mastectomy, Nerve Block, Bupivacaine

Brief summary

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

PROCEDURESerratus-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.

PROCEDUREErector 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.

DRUGDexmedetomidine Injection

The local anaesthetic mixture will include 0.25% bupivacaine plus 1 μg/kg dexmedetomidine.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 64 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The total opioid consumption.	The first 24 hours postoperative.	The total opioid consumption (morphine) in the first 24 hours postoperative.

Secondary

Measure	Time frame	Description
Time of the first rescue analgesia	The first 24 hours postoperative.	Time of the first rescue analgesia needed by the patient when visual analogue pain score ≥4.
The static and dynamic visual analogue scale	The first 24 hours postoperative.	The static and dynamic visual analogue scale pain score with score 10 indicates the maximum pain and score 0 indicates no pain.
Number of participants with procedure-related adverse events	The first 24 hours postoperative.	Associated side effects related to the procedure as vascular or nerve injury, pneumothorax, and local anaesthetic systemic toxicity.

Countries

Egypt

Contacts

STUDY_DIRECTORNahla Mohamed Amin, MD

Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

STUDY_CHAIRSamia Mohamed Masoud, MD