“Effectiveness of Erector Spinae Plane(ESP) Block for postoperative pain relief in breast surgeryâ€

Not yet recruiting

• Conditions: Malignant neoplasm of breast of unspecified site, ,

• Registration Number: CTRI/2022/05/042371
• Lead Sponsor: PDU Govt Medical College Rajkot

Brief Summary

Modified Radical Mastectomy(MRM)is one of the commonly performed surgery. It is associated with moderate-to-severepostoperative pain. Regional block for pain management has many advantages insuch patients including provision of adequate analgesia, reduced need foropioids, decreased postoperative nausea & vomiting, postoperative pulmonarycomplications, enhanced recovery, and early ambulation. The Ultrasound(US)/IITV guided Erector Spinae Plane Block (ESPB) was initially described byForero for providing thoracic analgesia at the T4 transverse process (TP). ESPBgained wide attention as it is a faster procedure that carries a lower risk ofhypotension, easy to perform, and requires less training.

Here, we compared the efficacy of unilateralErector Spinae Plane Block(ESP Block) with Bupivacaine (0.25%) with systemicpost-operative analgesics alone for duration, quality of post-operativeanalgesia for patients undergoing modified radical mastectomy.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-05
• Study Start: 2022-05-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• American Society of Anaesthesiologists(ASA) Grade – I, II and III patients b.
• Patients undergoing Modified Radical Mastectomy(MRM) surgery.

Exclusion Criteria

• American Society of Anaesthesiologists(ASA) Grade IV and V patients b.
• Patients of Age Group >65 years c.
• Infection at the block site d.
• Bleeding disorder or Patient is on Anti-Coagulation Therapy e.
• Allergic reaction to any anaesthetic drug f.
• Patients on tranquilizers, hypnotics, sedatives and other psychotropic drugs.
• Severe Hepatic/Renal/Endocrine/Neurologic/Gastrointestinal or Cardiac dysfunction h.
• Those who unable to speak or understand commands for analyzing sedation and analgesia.
• Spine deformity j.
• Patient’s refusal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total requirement of rescue analgesia in first 24 Hrs.	Postoperatively every 30 mins for first 2 hours, every 60 mins for next 6 hours and at 12th hour and 24th hour.

Secondary Outcome Measures

Name	Time	Method
a. Changes in Hemodynamic Parameters	b. Side Effects if any peri-operatively

Trial Locations

Locations (1)

P.D.U. Govt. Medical College, Rajkot; 🇮🇳 Rajkot, GUJARAT, India

P.D.U. Govt. Medical College, Rajkot

🇮🇳Rajkot, GUJARAT, India

Dr Parthkumar Vadgama

Principal investigator

8485961814

parthvadgama@gmail.com