FindTrial
Sign In

A randomised study to compare duration of analgesia when fentanyl or butorphanol or normal saline are added to 0.5 % bupivacaine intrathecally for LSCS.

A Placebo Controlled Randomized Trial To Compare Duration of Analgesia using Bupivacaine-Fentanyl Versus Bupivacaine-Butorphanol combination intrathecally for lscs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026284
Enrollment
90
Registered
2020-07-01
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: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: To compare the intraoperative duration of sensory block using fentanyl, butorphonal compare to saline when added 2 ml 0.5% bupivacaine given intrathecally for LSCS.: duration of introp

Sponsors

Dept of Anaesthesia and Crtitcal Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I and II hemodynamically stable Cessarian section

Exclusion criteria

Exclusion criteria: - Emergency caesarean section. - Contraindications to regional anesthesia such as local infections/sepsis at the site of lumbar puncture, space occupying lesions of the brain, anatomical disorders of spine, shock, etc - Hypersensitivity to study drugs - Deranged coagulation profile INR > 1.5 and a PTT > 40. - History of opioid dependence

Design outcomes

Primary

MeasureTime frame
To compare the intraoperative duration of sensory block using fentanyl, butorphonal compare to saline when added 2 ml 0.5% bupivacaine given intrathecally for LSCS.Timepoint: The assessment of sensory block by pinprick will be performed at every minute till maximum level is achieved. This will be the level which does not change in two readings taken 5 minâ??s apart. This time will be noted as the onset of sensory block. Sensory level will be checked every 15 minutes until regression to two segments below the highest level achieved. Intraoperative monitoring will be done every 15 min till the end of the surgery.—

Secondary

MeasureTime frame
To compare onset of sensory block, motor block, hemodynamic parameters with addition of fentanyl, butorophonal to bupivacaine compare to bupivacaine and saline group. To study the neonatal outcome using the APGAR score Timepoint: intraoperatively and 24 hours after surgery. FETAL MONITORING It will be done by assessing the APGAR SCORE at 1 min, 5 min and 10 min—

Countries

India

Contacts

Public ContactDr Pooja Abbi

Sri Guru Ram Das Institute Of Health Sciences

pooja.monga259@gmail.com8968088773

Outcome results

None listed

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