Serratus Anterior Plane Block Versus Paravertebral Block for Postmastectomy Analgesia

NCT02103946 | Withdrawn

• 1 other identifier: NCI- Cairo
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Acute Pain

Keywords

serratus; paravertebral; breast; cancer; axilla

Outcome Measures

Primary Outcomes (1)

• pain relief

  reduction of pain intensities in the first postoperative day after breast surgery for cancer.

  first postoperative day

Secondary Outcomes (1)

• opioid consumption

  intraoperative and first postoperative day

Other Outcomes (1)

• patient satisfaction

  first week after surgery

Study Arms (2)

Serratus anterior muscle plane block

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

Serratus Anterior Muscle Plane block (SAM block) PROCEDURE

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

Serratus anterior muscle plane block

Paravertebral Block PROCEDURE

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

Paravertebral block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Kasr Alainy, 11796, Egypt

Location

Related Publications (3)

• 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.

  PMID: 20947592 BACKGROUND

• 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.

  PMID: 15322443 BACKGROUND

• 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.

  PMID: 23923989 RESULT

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms; Acute Pain; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghada MN Bashandy, MD

  Lecturer of anesthesia & pain relief

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: April 4, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

EG (1)