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To study the effect of different doses of butarphanol injected in the outermost space around the spinal cord for postoperative pain relief in patients undergoing casearean section

Safety and efficacy of different doses of epidural butorphanol with bupivacaine for postoperative analgesia following caesarean deliveries- a randomized double blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010165
Enrollment
100
Registered
2017-10-23
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: null- 100 pregnant patients

Interventions

Intervention1: Group B: Patientâ??s received epidural bupivacaine 0.125% (9ml) plus butorphanol 0.5mg
diluted in normal saline to a total volume of 10ml. Intervention2: Group C: Patientâ??s received epidural bupivacaine 0.125% (9ml) plus butorphanol 1 mg
diluted in normal saline to a total volume of 10ml. Intervention3: Group D: Patientâ??s received epidural bupivacaine 0.125% (9ml) plus butorphanol 2mg
diluted in normal saline to a total volume of 10ml. Control Intervention1: Group A: Patientâ??s received epidural bupivacaine 0.125% (9ml)
diluted in normal saline to a total volume of 10ml.

Sponsors

Deen Dayal Upadhyay Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A total of 100 parturients belonging to ASA grade I or II in the age group of 18-40 years (complete years), undergoing elective caesarean section using combined spinal-epidural anaesthesia technique were included in the study.

Exclusion criteria

Exclusion criteria: 1. Parturients having respiratory, cardiovascular or neuromuscular disease. 2. Parturients with complicated pregnancy or foetal distress. 3. Spinal anomaly or history of back surgery. 4. Patients recieving drugs that modify pain perception like NSAIDS, steroids, psychotropic, hypnotic drugs and anticoagulants. 5. Known hypersensensitivity to any of the study drug. 6. History of atopy or pruritis. 7. History of obstructive sleep apnoea. 8. Patients with bleeding disorder or any other comorbidity where spinal or epidural anaesthesia would otherwise be a relative contraindication were excluded from the study.

Design outcomes

Primary

MeasureTime frame
To study and compare the efficacy of different doses of epidural butorphanol (0mg, 0.5mg, 1mg, 2mg) with 0.125% bupivacaine (9ml) combination for postoperative analgesia following caesarean section using combined spinal-epidural anaesthesia techniqueTimepoint: 24 hours—

Secondary

MeasureTime frame
To study and compare the side effects, if observed with any of the study drug combinations used.Timepoint: 24 hours—

Countries

India

Contacts

Public ContactDr Monika Singh

Deen Dayal Upadhyay Hospital, Govt. of NCT of Delhi

ajayannu@gmail.com9718990114

Outcome results

None listed

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