Serratus Anterior Plane Block Versus Paravertebral Block for Postmastectomy Analgesia (SAM)

National Cancer Institute, Egypt

Status: Withdrawn

Conditions: Breast Cancer; Acute Pain

Treatments: Procedure: Serratus Anterior Muscle Plane block (SAM block); Procedure: Paravertebral Block

Study type: Interventional

Funder types: Other

Identifiers

NCT02103946

NCI- Cairo

Details and patient eligibility

About

ًًًُُُُ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.

Full 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.

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Serratus anterior muscle plane block

Active Comparator group

Description:

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

Treatment:

Procedure: Serratus Anterior Muscle Plane block (SAM block)

Paravertebral block

Active Comparator group

Description:

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

Treatment:

Procedure: Paravertebral Block