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SAP Block to Reduce Post Mastectomy Pain

Not Applicable
Completed
Conditions
Serratus Anterior Plain Block
Interventions
Drug: Normal saline
Registration Number
NCT03810209
Lead Sponsor
Suez Canal University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
magnesium sulphate groupMagnesium SulphateThe 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.
control groupNormal salineThe 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.
Primary Outcome Measures
NameTimeMethod
The duration of analgesia measured by the time of first analgesic requestpost operative 24 hours

magnesium group showed delayed first analgesic request

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Suez Canal University

🇪🇬

Ismailia, Egypt

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