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SAP Block to Reduce Post Mastectomy Pain

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ClinicalTrials.gov Identifier: NCT03810209
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Abdelrhman Alshawadfy, Suez Canal University

Brief Summary:
To decrease post-operative pain in patients undergoing modified radical mastectomy.

Condition or disease Intervention/treatment Phase
Serratus Anterior Plain Block Drug: Magnesium Sulphate Drug: Normal saline Not Applicable

Detailed Description:

The Serratus anterior Plane (SAP) Block has proven to be an effective component of multimodal analgesic regimens for a variety of thoracic procedures. It is designed to block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax and it may be a viable alternative to paravertebral blockade and thoracic epidural analgesia and may be associated with fewer side effects. It's straight forward to perform, with high success rate and minimal incidence of complications.

It was reported prolonged numbness over the area supplied by the lateral cutaneous branches of the T2-T9 spinal nerves using only 0.4 ml.kg−10.125% levobupivacaine. This is remarkable, because alternative techniques such as intercostal, interpleural and thoracic paravertebral block require relatively high concentrations and volumes of local anesthetics to produce similarly prolonged, multi-dermatomal thoracic analgesia.The duration of Serratus plane block is limited to the effect of administered local anesthetics (LAs). However, recently adjuvants such as epinephrine, ketamine and clonidine are added to LA solution in concentrations advocated for other peripheral blocks to prolong the effect of block with promising results.

Evidence supporting the presence of N-methyl-D-aspartate (NMDA) receptors in skin and muscles have led to the use of magnesium sulphate (MgSO4) (NMDA antagonist) via different routes for brachial plexus block and via neuraxial route. Until date, no study has been done to evaluate the role of MgSO4 as an adjuvant in SAP block. Therefore, the investigators intended this study to evaluate the role of MgSO4 as an adjuvant to bupivacaine in ultrasound (USG)-guided SAP block for postoperative analgesia in patients scheduled for modified radical mastectomy.

While the key requirement for successful regional anesthetic blocks is ensuring optimal distribution of local anesthetic around nerve structures, ultrasound guidance enables the anesthetist to secure an accurate needle position and to monitor the distribution of the local anesthetic in real time.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Adding Magnesium Sulphate to Bupivacaine on the Quality of Ultrasound-guided Serratus Plane Block in Patients Undergoing a Modified Radical Mastectomy
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : December 11, 2018
Actual Study Completion Date : January 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Active Comparator: magnesium sulphate group
The investigator injected 28.5 mL of bupivacaine 0.5% and 1.5 ml MgSo4 (150 mg), a total volume of 30 ml, it was confirmed visually by the ultrasound.
Drug: Magnesium Sulphate
adding magnesium sulphate to local anaesthetic in SAP Block

Placebo Comparator: control group
The investigator injected 28.5 mL of Bupivacaine 0.5% and 1.5 mL of normal saline, a total volume of 30 ml, it was confirmed visually by the ultrasound.
Drug: Normal saline
adding normal saline to local anaesthetic in SAP block




Primary Outcome Measures :
  1. The duration of analgesia measured by the time of first analgesic request [ Time Frame: post operative 24 hours ]
    magnesium group showed delayed first analgesic request



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females with breast cancer for modified radical mastectomy
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult, female patients, ASA physical status I, II, and III aged older than 18 years scheduled for modified radical mastectomy surgery under general anesthesia.

Exclusion Criteria:

Any known allergies to the study drugs. Anatomical abnormalities or infections in the serratus region. Bleeding disorders e.g. thrombocytopenia, high INR, high PT in chronic liver or impaired kidney). Patients on chronic pain medications or regularly receiving analgesics. Pregnant or breast feeding patients. Body Mass Index (BMI) more than 35.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810209


Locations
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Egypt
Suez Canal University
Ismailia, Egypt
Sponsors and Collaborators
Suez Canal University
Investigators
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Principal Investigator: abdelrhman alshawadfy suez canal univesity

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Responsible Party: Abdelrhman Alshawadfy, clinical professor, Suez Canal University
ClinicalTrials.gov Identifier: NCT03810209     History of Changes
Other Study ID Numbers: SAP Block in Mastectomy
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Magnesium Sulfate
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents