A Clinical trial to study the effect of fentanyl and buprenorphine in spinal anesthesia to decrease the post-operative pain in patients undergoing lower abdominal surgeries.

Comparative Study Of The Analgesic Effect Of Fentanyl And Buprenorphine As Spinal Adjuvants In Adult Patients Undergoing Infraumbilical Surgeries :A Randomized Double- Blind Controlled Study. - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061835

Enrollment

120

Registered

2024-01-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: K421- Umbilical hernia with gangrene

Interventions

Intervention1: FENTANYL: inj.fentanyl 25mcg with inj.Bupivacaine (0.5%) 3ml for 24 hours Control Intervention1: Buprenorphine: inj.buprenorphine 60mcg with inj.bupivacaine (0.5%) 3ml for 24 hours.

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologist Grade I and II patients. Age 18-65 years of either gender. Patients undergoing infraumbilical Surgeries. Height is more than 4 feet. Patients willing to give consent.

Exclusion criteria

Exclusion criteria: American Society of Anesthesiologists Grade III and IV patients. Patients with known contraindications for spinal anesthesia: bleeding disorders, local infection. Patients with cardiovascular instability. Patients with comorbidities like Hypertension, Diabetes Mellitus, cardiac diseases, etc. Patient with allergy to opioids or history of hypersensitivity to local anesthetics. Emergency surgeries. Patients with a history of severe PDPH or PONV after spinal anesthesia. Patients not willing to give informed written consent.

Design outcomes

Primary

Measure	Time frame
the duration of sensory & motor blockade.Timepoint: 15min 30min 45min	—

Secondary

Measure	Time frame
1. The onset of sensory & motor blocks was achieved. 2.The level of blockade achieved. 3. The efficacy of postoperative analgesia. 4. Side effects like hemodynamic changes (hypotension and bradycardia) sedation, pruritus, post-operative nausea and vomiting and respiratory depression. Timepoint: 15min, 30min,45min	—

Countries

India

Contacts

Public ContactDr.Vaishali Sarote

Mahatma Gandhi Institute Of Medical Science

suchetatidke@mgims.ac.in9850510019

Outcome results

None listed

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