to compare a local anaesthetic (ropivacaine ) which is given for spinal anaesthesia (injection in back for doing surgery) and addition of other drugs (fentanyl or butorphanol : both are opioids) in patients with surgery to be done below the navel.

A Randomised trial to compare the effect of addition of Fentanyl or Butorphanol to hyperbaric Ropivacaine for spinal anaesthesia in elective infra umbilical surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/11/047616

Enrollment

Registered

2022-11-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: hyperbaric ropivacaine with fentanyl: for spinal anaesthesia, patients will receive a single injection of 15 mg hyperbaric ropivacaine with 25 microgram fentanyl over 0.1ml/sec Interven

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) physical status I - II 2. Age – 18-60 years 3. Scheduled to undergo infra umbilical elective surgery under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1.Emergency patients. 2. Obesity (BMI > 30 kg/m2 ), 3. Allergy to study drugs, 4. Inability to comply with the study procedure, i.e. psychiatric disorder, language problems, history of chronic pain, alcohol, drug or medication abuse . 5. Patients with history of cardiac, liver or renal disorders. 6. Pregnancy.

Design outcomes

Primary

Measure	Time frame
To assess the duration of sensori-motor block in the three groups.Timepoint: baseline, 0, 5 ,10 ,15, 30 ,45, 60,90,120,180 minutes	—

Secondary

Measure	Time frame
To assess the patient satisfaction.Timepoint: 30 minute after spinal anaesthesia;to study any complications if anyTimepoint: from initiation of spinal anaesthesia till the patient recovers from the effect of the spinal anaesthesia;To study the hemodynamic parametersTimepoint: baseline, 0, 5 ,10 ,15, 30 ,45, 60,90,120,180 minutes	—

Countries

India

Contacts

Public ContactDr Ravneet Kaur Gill

Dr B R Ambedkar State Institute of Medical Sciences

drravneetkgill@gmail.com9501988361

Outcome results

None listed

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