To compare postoperative analgesic efficacy after infiltrating Bupivacaine with Dexmedetomidine vs Bupivacaine alone at surgical incision site in below umbilical surgeries.

Phase 4

Not yet recruiting

• Registration Number: CTRI/2025/06/088250
• Lead Sponsor: Dr Punit kumar

Brief Summary

This study is a prospective, interventional, randomized comparison of the postoperative analgesic effect of bupivacaine with dexmedetomidine versus bupivacaine alone for local infiltration at the surgical incision site in infraumbilical surgeries. A total of 148 patients aged 18 to 50 years undergoing infraumbilical surgeries were randomly divided into two groups. Group DB received 20 mL of 0.25 percent bupivacaine with 50 mcg dexmedetomidine, and Group PB received 20 mL of 0.25 percent bupivacaine with 0.5 mL normal saline. The study assessed duration of analgesia, total rescue analgesic requirement in 24 hours, VAS pain scores, and hemodynamic changes. Pain was measured using the Visual Analogue Scale at regular intervals and rescue analgesia was administered if the VAS score was 4 or more. Hemodynamic parameters were monitored, and data were analyzed using standard statistical methods.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-27
• Study Start: 2025-07-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• 1.Patients giving informed consent to participate in the study.
• 2.All patients posted for below umbilicus surgeries.
• 3.Age of the patient between 18-50 years.
• 4.Patients belonging to ASA I & ASA II.

Exclusion Criteria

• 1.Patients with morbid obesity 2.Patients with Raynaud’s disease 3.Patients belonging to ASA class III and IV.
• 4.Patients with co morbidities 5.Patients with infection at the site of infiltration.
• 6.Patients with psychiatric disorders.
• 7.Patients with history of hypersensitivity to any of the drugs under study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the duration of postoperative analgesia after local infiltration in both groups, Bupivacaine alone and Bupivacaine mixed with Dexmedetomidine	at 5 minutes, 30 minutes, 45 minutes, 75 minutes, 90 minutes, 2hour, 4 hour, 6 hour, 12 hour, 24 hour

Secondary Outcome Measures

Name	Time	Method
To calculate the total amount of rescue analgesic consumed in 24 hours	at 3 hour, 6 hour, 12 hour, 24 hour
To observe VAS score after infiltration	at 5 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 2 hour, 4 hour, 6 hour, 12 hour, 24 hour
To observe the hemodynamic changes after local infiltration of Dexmedetomidine added to Bupivacaine at incision site	at 15 minutes, 30 minutes, 45 minutes, 60 minutes, 3 hour, 6 hour, 9 hour, 12 hour, 16 hour, 20 hour, 24 hour

Trial Locations

Locations (1)

Susheela tiwari government hospital; 🇮🇳 Nainital, UTTARANCHAL, India

Susheela tiwari government hospital

🇮🇳Nainital, UTTARANCHAL, India

Dr Punit Kumar

Principal investigator

9759889895

drpuneetk007@gmail.com