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

Serratus Anterior Muscle Plane Block Versus Paravertebral Block for Breast Cancer Resections.

ًًًُُُُ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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer; Acute Pain
• Intervention / Treatment: Procedure: Serratus Anterior Muscle Plane block (SAM block); Procedure: 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kasr Alainy
    • Cairo, Kasr Alainy, Egypt, 11796
      • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Serratus anterior muscle plane 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	Procedure: Serratus Anterior Muscle Plane block (SAM 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.; Other Names: Serratus anterior block; intercostal nerve block
Active Comparator: 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	Procedure: Paravertebral 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.; Other Names: Thoracic Paravertebral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain relief	reduction of pain intensities in the first postoperative day after breast surgery for cancer.	first postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption	intraoperative and postoperative opioid consumption	intraoperative and first postoperative day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	measure patient satisfaction a week after surgery	first week after surgery

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Ghada MN Bashandy, MD, Lecturer of anesthesia & pain relief

Publications and helpful links

General Publications

• Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14. Erratum In: Br J Anaesth. 2013 Sep;111(3):522.
• Mendoza TR, Chen C, Brugger A, Hubbard R, Snabes M, Palmer SN, Zhang Q, Cleeland CS. The utility and validity of the modified brief pain inventory in a multiple-dose postoperative analgesic trial. Clin J Pain. 2004 Sep-Oct;20(5):357-62. doi: 10.1097/00002508-200409000-00011.
• Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

Helpful Links

• Serratus plane block: a novel ultrasound-guided thoracic wall nerve block

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 8, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: cancer; breast; axilla; serratus; paravertebral
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Breast Neoplasms; Acute Pain
• Other Study ID Numbers: NCI- Cairo