Serratus Anterior Plane Block Versus Paravertebral Block for Postmastectomy Analgesia

Not Applicable

Withdrawn

• Conditions: Breast Cancer; Acute Pain
• Interventions: Procedure: Serratus Anterior Muscle Plane block (SAM block); Procedure: Paravertebral Block

• Registration Number: NCT02103946
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

ًًًُُُُThe investigators are testing the efficacy of a new novel technique; serratus anterior plane block, for preventing postoperative pain after breast surgery for cancer. This block will be compared with the well-established paravertebral block.

Detailed Description

Paravertebral block (PVB) can be considered as a well-established option to provide anesthesia and postoperative analgesia during breast surgery. For patients receiving a PVB alone or in combination with general anesthesia significant lower resting, evoked and worst pain scores compared with other analgesic treatment strategies indicating that a PVB provides improved postoperative pain control in patients undergoing breast surgery. Furthermore, there might be a reduced need for postoperative opioid requirements and consecutively a decrease in opioid-induced adverse effects in patients receiving a PVB. Anyways there are always fear of pleural injury and pneumothorax in addition to epidural and intrathecal spread of the block. A novel newly introduced field block has been described recently to block the hemithorax under ultrasound guidance that is the Serratus Anterior Muscle Plane SAM block. Still this technique to the investigators knowledge is not tried in randomized clinical studies. The aim of this study is to find out that this new technique is comparable to PVB in patients undergoing breast surgeries with or without axillary node dissection.

Study Timeline

• Study First Submitted: 2014-03-04
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-08
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• unilateral mastectomy with or without axillary lymph node dissection.
• American Society of Anesthesia (ASA) I&II

Exclusion Criteria

• morbid obesity (body mass index > 40 kg/m2);
• renal insufficiency (creatinine > 1.5 mg/dL),
• current chronic analgesic therapy (daily use > 4 weeks),
• a history of opioid dependence, pregnancy,
• inability to communicate with the investigators or hospital staff,
• American Society of Anesthesia (ASA) III-IV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serratus anterior muscle plane block	Serratus Anterior Muscle Plane block (SAM block)	Serratus anterior muscle plane block with general anesthesia MARCAINE® 0.25%w/v solution for injection. DIPRIVAN® (propofol), 2 to 2.5 mg/kg NIMBEX® (cisatracurium besylate) Injection, 0.15-0.2 mg\\Kg Fentanyl, 1-2 mic\\Kg Paracetamol, 1000 mg\\6 hours Fam® (Ketorolac), 30 mg
Paravertebral block	Paravertebral Block	Paravertebral block with general anesthesia. MARCAINE® 0.25%w/v solution for injection. DIPRIVAN® (propofol), 2 to 2.5 mg/kg NIMBEX® (cisatracurium besylate) Injection, 0.15-0.2 mg\\Kg Fentanyl, 1-2 mic\\Kg Paracetamol, 1000 mg\\6 hours Fam® (Ketorolac), 30 mg

Primary Outcome Measures

Name	Time	Method
pain relief	first postoperative day	reduction of pain intensities in the first postoperative day after breast surgery for cancer.

Secondary Outcome Measures

Name	Time	Method
opioid consumption	intraoperative and first postoperative day	intraoperative and postoperative opioid consumption

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Kasr Alainy, Egypt