RecruitingPhase 4ACTRN12616000298415

Pectoral nerve blocks and quality of recovery following breast surgery

Do pectoral nerve blocks improve patient quality of recovery following breast surgery?: a randomized controlled trial


Sponsor

Dr Gloria Seah

Enrollment

104 participants

Start Date

Aug 16, 2016

Study Type

Interventional

Conditions

Summary

OBJECTIVES: To compare patient quality of recovery following breast surgery in those who receive pectoral nerve (Pecs) II blockade versus local anaesthetic infiltration by surgeons. DESIGN, SETTING, PARTICIPANTS: Prospective, triple-masked, randomised controlled trial of 104 female, adult, non-pregnant participants with an allocation ratio of 1:1. This will be conducted at St Vincent’s Hospital Melbourne and Peter MacCallum Cancer Centre. Recruitment of participants is planned from March 2016 to January 2018. Patients, investigators and all staff caring for patients and those making postoperative assessments will be blinded to group allocation. INTERVENTIONS: Patients will receive: a) Pecs II block and placebo surgical infiltration or b) Placebo Pecs II block and local anaesthetic surgical infiltration. Both will receive a standardised general anaesthetic and multimodal analgesia technique. MAIN OUTCOME MEASURES: The primary outcome measure will be patient quality of recovery (QoR) using the QoR-15 questionnaire at 24 hours. Secondary outcomes include assessment of pain related physical and functional interference using the Brief Pain Inventory three months post surgery and opioid consumption presented as oral morphine equivalent (OME) in the first 24 hour post-operative period.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two pain management approaches for women having breast surgery. One group receives a nerve block injection (pectoral nerve block) before surgery to numb the chest area, while the other group receives local anaesthetic from the surgeon during the procedure. All patients also receive a general anaesthetic. The main outcome is how well patients feel at 24 hours after surgery, and pain levels are also tracked at 3 months. You may be eligible if: - You are an adult woman - You are having planned (elective) breast surgery on one side (wide local excision, mastectomy, or lymph node removal) - You are in good to moderate health (ASA score I to III) You may NOT be eligible if: - You are male - Your BMI is above 45 - You weigh less than 50 kg - You have significant kidney or liver problems - You have a drug or alcohol dependency - You have an allergy to any of the medications used in the procedure - You are pregnant - You are not a native English speaker, have cognitive difficulties, or have psychiatric illness that would prevent you from completing study questionnaires Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Ultrasound-guided pectoral nerve block (Pecs 2) with ropivacaine 0.475% 0.2ml/kg in the plane between pectoralis major and minor AND ropivacaine 0.475% 0.25ml/kg in the plane deep to pectoralis minor

Ultrasound-guided pectoral nerve block (Pecs 2) with ropivacaine 0.475% 0.2ml/kg in the plane between pectoralis major and minor AND ropivacaine 0.475% 0.25ml/kg in the plane deep to pectoralis minor will be injected by anaesthetist prior to general anaesthesia, in addition to standardised general anaesthesia. Identical volume of 0.9% sodium chloride (normal saline) infiltrated subcutaneously by surgeons at wound edges prior to wound closure. Adherence is ensured by Pecs 2 block being performed by anaesthetists trained in Pecs 2 block. Surgeons will be notified of the protocol for wound infiltration.


Locations(3)

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

VIC, Australia

Peter MacCallum Cancer Centre - Melbourne

VIC, Australia

Hamilton, New Zealand

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ACTRN12616000298415