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OpenTrials
Completed

NCT Number: NCT03810209

SAP Block to Reduce Post Mastectomy Pain

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium sulphate

Drug

adding magnesium sulphate to local anaesthetic in SAP Block

Other names: MgSO4

normal saline

Drug

adding normal saline to local anaesthetic in SAP block

Other names: NaCl

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

Effect of Adding Magnesium Sulphate to Bupivacaine on the Quality of Ultrasound-guided Serratus Plane Block in Patients Undergoing a Modified Radical Mastectomy

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 18, 2019
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.