Skip to main content
Clinical Trials/CTRI/2025/10/095633
CTRI/2025/10/095633
Not yet recruiting
Phase 4

Comparison Of Postoperative Analgesic Efficacy Of 0.5 Percentage Ropivacaine With Dexmedetomidine Versus 0.5 Percentage Ropivacaine With Nalbuphine In Ultrasound Guided Erector Spinae Plane Block For Breast Augmentation Surgeries A Prospective Randomized Double Blinded Study

Mohammed Asjad T1 site in 1 country100 target enrollmentStarted: October 17, 2025Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Mohammed Asjad T
Enrollment
100
Locations
1
Primary Endpoint
Duration of postoperative analgesia measured as the time interval between administration of ESP block and first rescue analgesic requirement, recorded in minutes or hours within 24 hours post surgery.

Overview

Brief Summary

This prospective, randomized, double blind study was conducted to compare the postoperative analgesic efficacy of two drug combinations in ultrasound guided erector spinae plane ESP block for patients undergoing breast augmentation surgery. One group received 0.5 Percentage ropivacaine with dexmedetomidine, while the other received 0.5 Percentage ropivacaine with nalbuphine.

The study assessed parameters such as

Duration and quality of postoperative analgesia

Total rescue analgesic requirement

Hemodynamic stability and side effects

The results indicated which adjuvant dexmedetomidine or nalbuphine when combined with ropivacaine, provided superior and longer-lasting pain relief with minimal adverse effects.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)

Inclusion Criteria

  • Patients under ASA Physical Status I and II undergoing breast augmentation surgery Plastic Surgery.
  • Gender Transgender patients.
  • Patients with BMI between 20 to 30 kg per m².

Exclusion Criteria

  • Severe spinal deformity.
  • Known allergy to local anaesthetics.
  • Systemic illnesses such as uncontrolled hypertension, diabetes, seizure disorder, cardiopulmonary disease.
  • Bleeding disorders, block site infection, hepatic or renal dysfunction.
  • BMI more than 30 kg per m².
  • Patients on anticoagulants/blood thinners.
  • History of head injury.
  • Psychiatric illness.

Outcomes

Primary Outcomes

Duration of postoperative analgesia measured as the time interval between administration of ESP block and first rescue analgesic requirement, recorded in minutes or hours within 24 hours post surgery.

Time Frame: Duration of postoperative analgesia measured as the time interval between administration of ESP block and first rescue analgesic requirement, recorded in baseline , 12th hr and 24th hr post surgery.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Mohammed Asjad T
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Mohammed Asjad T

Shri Sathya Sai Medical Collgege And Research Institute.

Study Sites (1)

Loading locations...

Similar Trials