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Clinical Trials/CTRI/2025/09/094249
CTRI/2025/09/094249
Not yet recruiting
Phase 2

Comparison of postoperative analgesic efficacy of ultrasound guided modified pectoralis plane block and serratus anterior plane block in benign breast surgery – A randomized controlled trial

sri manakulla vinayagar medical college1 site in 1 country80 target enrollmentStarted: September 21, 2025Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
sri manakulla vinayagar medical college
Enrollment
80
Locations
1
Primary Endpoint
post extubation VAS score

Overview

Brief Summary

This is a randomised controlled trial aiming to compare postoperative analgesic efficacy of two ultrasound guided modified pectoralis plane block and serratus anterior plane block in 80 female patient undergoing elective benign breast surgeries conducted at sri manakula vinayagr medical college and hosptal ,the study assesses pain relief by monitoring VAS and analgesic consumption postoperatively .Participants are randomly assigned into two equal groups Group A receiving PECS block and group B receiving SAP block both 20 ml of 0.25% bupivacaine with 8mg dexamethasone.The methodology involves strict aseptic technique and ultrasound guidance for block administration.standardized anaesthesia protocol are followed,including I gel insertion and maintained with sevoflurane ,oxygen,nitrous oxide ,postoperative pain assessed at multiple time over period of 24 hrs,with rescue analgesia administered if VAS more than 4 .Statiscal analysis using SPSS will compare pain score,time to first analgesia and total analgesic use.Ethical consideration incuded informed consent ,confidentiality,risk minimization and non monentary compensation for adverse events,with categorised as low risk and approved by IEC.This literature review support to study rationalae ,citing previous trials where both blocks improved analgesia and reduced opioid use .studies by Magoon,wang and other highlight the effectiveness of these blocks in thoracic and breast surgeries

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Patients admitted for elective benign breast surgery Patients of ASA physical status classification I and II Female patients with age of 18-65 years.

Exclusion Criteria

  • Patient refusal Allergy to study drugs Surgery of breast carcinoma Emergency surgeries Local Infection Coagulopathy Spine deformity Pregnancy.

Outcomes

Primary Outcomes

post extubation VAS score

Time Frame: at 15 min

Secondary Outcomes

  • VAS score(1, 2, 4, 6, 8, 12, 24 hours)
  • Time to first rescue analgesia(hours)
  • total analgesic requirement(over 24-hour period)

Investigators

Sponsor
sri manakulla vinayagar medical college
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

PDEVISRI

Sri manakulla vinayagar medical college

Study Sites (1)

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