Serratus Anterior Plane Block Versus Paravertebral Block for Postmastectomy Analgesia

Breast Cancer Clinical Trial

— SAM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02103946
• Other study ID #: NCI- Cairo
• Status: Withdrawn
• Phase: N/A
• First received: March 4, 2014
• Last updated: April 8, 2018
• Start date: April 2014
• Est. completion date: August 2014

Study information

• Verified date: April 2018
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo	Kasr Alainy

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Review. Erratum in: Br J Anaesth. 2013 Sep;111(3):522. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient satisfaction	measure patient satisfaction a week after surgery	first week after surgery
Primary	pain relief	reduction of pain intensities in the first postoperative day after breast surgery for cancer.	first postoperative day
Secondary	opioid consumption	intraoperative and postoperative opioid consumption	intraoperative and first postoperative day

External Links

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