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

Primary Purpose

Breast Cancer, Acute Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Serratus Anterior Muscle Plane block (SAM block)
Paravertebral Block
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring serratus, paravertebral, breast, cancer, axilla

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Serratus anterior muscle plane block

Paravertebral block

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

opioid consumption
intraoperative and postoperative opioid consumption

Full Information

First Posted
March 4, 2014
Last Updated
April 8, 2018
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT02103946
Brief Title
Serratus Anterior Plane Block Versus Paravertebral Block for Postmastectomy Analgesia
Acronym
SAM
Official Title
Serratus Anterior Muscle Plane Block Versus Paravertebral Block for Breast Cancer Resections.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Acute Pain
Keywords
serratus, paravertebral, breast, cancer, axilla

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Serratus anterior muscle plane block
Arm Type
Active Comparator
Arm 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
Arm Title
Paravertebral block
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Serratus Anterior Muscle Plane block (SAM block)
Other Intervention Name(s)
Serratus anterior block, intercostal nerve block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Paravertebral Block
Other Intervention Name(s)
Thoracic Paravertebral block
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain relief
Description
reduction of pain intensities in the first postoperative day after breast surgery for cancer.
Time Frame
first postoperative day
Secondary Outcome Measure Information:
Title
opioid consumption
Description
intraoperative and postoperative opioid consumption
Time Frame
intraoperative and first postoperative day
Other Pre-specified Outcome Measures:
Title
patient satisfaction
Description
measure patient satisfaction a week after surgery
Time Frame
first week after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghada MN Bashandy, MD
Organizational Affiliation
Lecturer of anesthesia & pain relief
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
State/Province
Kasr Alainy
ZIP/Postal Code
11796
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
20947592
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. Erratum In: Br J Anaesth. 2013 Sep;111(3):522.
Results Reference
background
PubMed Identifier
15322443
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. doi: 10.1097/00002508-200409000-00011.
Results Reference
background
PubMed Identifier
23923989
Citation
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.
Results Reference
result

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Serratus Anterior Plane Block Versus Paravertebral Block for Postmastectomy Analgesia

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