FindTrial
Sign In

A study to compare Fentanyl and Butorphanol as adjuvant drugs to local anesthetics in combined spinal and epidural anaesthesia in surgeries on legs

Comparison between fentanyl and butorphanol as epidural adjuvants in combined spinal epidural anaesthesia for lower limb surgeries - A prospective randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023181
Enrollment
46
Registered
2020-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M80-M85- Disorders of bone density and structure

Interventions

Intervention1: Fentanyl: At the end of surgery, Epidural bolus of 10ml 0.125% Bupivacaine with 1mcg/kg of Fentanyl will be given for post-operative pain relief Intervention2: Butorphanol: At the end o

Sponsors

Sangeetha G G
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective lower limb surgeries under combined spinal and epidural anaesthesia American Society of Anaesthesiologist I or II

Exclusion criteria

Exclusion criteria: Patient refusal Patients allergic to local anesthetics/Butorphanol/Fentanyl American Society of Anaesthesiologist III and above Patients with coagulation disorders Local site infection BMI above 30 Poorly controlled Hypertension Poorly controlled Diabetes mellitus Patients with cardiac pathology Pregnant patients

Design outcomes

Primary

MeasureTime frame
To determine the quality and duration of analgesia postoperatively using Visual analogue scale and time of requirement of rescue analgesia respectivelyTimepoint: Postoperative Period—

Secondary

MeasureTime frame
To assess sedation score and adverse effects such as pruritis, nausea and vomiting, shivering, hemodynamic stability up to 24 hours postoperatively between the two groupsTimepoint: Postoperative Period—

Countries

India

Contacts

Public ContactSangeetha G G

Shri Sathya Sai Medical College and Research Institute

esenkeyem@gmail.com9786743120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026