An interventional study of Serratus Anterior Muscle Plane block (SAM block) and Paravertebral Block in Breast Cancer and Acute Pain, sponsored by National Cancer Institute, Egypt. Withdrawn at 1 site in Egypt. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-10.
Sponsored by National Cancer Institute, Egypt · Not applicable, Interventional, and Treatment
ًًًُُُُ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.
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.
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Exclusion Criteria:
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
Procedure: Serratus Anterior Muscle Plane block (SAM 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
Procedure: Paravertebral Block
The US probe is placed in the mid-axillary line at level of the 6th intercostal space. From caudal to cranial, an in-plane approach, the block needle is inserted until the tip is placed between SAM and intercostal muscles and the LA injection will be visualized in real-time. The injection usually consists of 0.4ml/kg of bupivacaine 0.25% plus adrenaline (5ug/ml). Intraoperatively, all subjects will receive a general anesthetic using inhaled anesthetic and oxygen. Intravenous fentanyl will be administered for cardiovascular stability to noxious stimuli.For postoperative analgesia, all subjects will receive oral acetaminophen. Patients will receive a ketorolac IV injection then morphine as a rescue analgesic for breakthrough pain.
Also known as: Serratus anterior block, intercostal nerve block
After skin preparation and sterile draping applied. Target paravertebral space will be located using US guidance. The paravertebral space between the third and fourth thoracic vertebrae will be identified in a parasagittal view approximately 3 cm lateral to midline on the side of surgery. A local anesthetic skin wheal will be raised caudal to the ultrasound transducer. A 17-gauge, Tuohy-tip needle will be inserted through the skin wheal in-plane beneath the ultrasound transducer and directed to the paravertebral space. Normal saline (5 mL) will be injected via the needle to help identify the paravertebral space and observe the pleura being displaced anteriorly. 0.4 ml\\kg of 0.25% Bupivacaine with epinephrine, 5 μg/mL, will be slowly injected with gentle aspiration every 3 mL.
Also known as: Thoracic Paravertebral block
pain relief
reduction of pain intensities in the first postoperative day after breast surgery for cancer.
Time frame: first postoperative day
opioid consumption
intraoperative and postoperative opioid consumption
Time frame: intraoperative and first postoperative day
patient satisfaction
measure patient satisfaction a week after surgery
Time frame: first week after surgery
This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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National Cancer Institute, Egypt