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Clinical Trials/CTRI/2024/05/066703
CTRI/2024/05/066703
Completed
Phase 1

Postoperative analgesic efficacy of Erector Spinae Plane Block VS Serratus Anterior Plane Block in patients undergoing Modified Radical Mastectomy

Father Muller Medical College1 site in 1 country80 target enrollmentStarted: June 1, 2024Last updated:

Overview

Phase
Phase 1
Status
Completed
Sponsor
Father Muller Medical College
Enrollment
80
Locations
1
Primary Endpoint
analgesic efficacy and safety profile between both groups

Overview

Brief Summary

Erector Spinae plane Block (ESPB) is a newer block that has been successfully used for

many surgeries involving chest wall and is also useful for pain relief in rib fractures

Its success in MRM has been documented

For Radical surgeries like MRM, it is simple and convenient to administer blocks away from

the surgical site. Serratus Anterior plane block (SAPB) is a relatively newer block which was primarily used

for management of pain from rib fractures, there is potential for its use in MRM as an

alternate when it is difficult to administer ESP block as the anterior branch of intercostal

nerves lie under the serratus anterior muscle

We plan to compare the analgesic efficacy of ESP with SAB , to determine the superiority of

either , and the compare the ease of administration of the block.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • American Society of Anaesthesiologists physical status I-IV.

Exclusion Criteria

  • Patient refusal Patients who are being treated with drugs that compromise the study benzodiazepines and sedatives like lithium, opioids like morpine.
  • Pregnant women.
  • Patients with significant neurological or respiratory diseases -Patients with BMI more than
  • Local anesthetic allergy.

Outcomes

Primary Outcomes

analgesic efficacy and safety profile between both groups

Time Frame: postoperatively at 1 hour to 24 hours

Secondary Outcomes

  • Superiority of one block over the other(12 months)

Investigators

Sponsor
Father Muller Medical College
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Divya Vincent

Father Muller Medical College

Study Sites (1)

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