To compare analgesic effect of two different doses of intrathecal nalbuphine (0.8 mg versus 1.6mg) as an adjuvant to 0.75% isobaric ropivacaine along with control group for elective lower limb surgeries

Not yet recruiting

• Conditions: Disorder of continuity of bone, unspecified,

• Registration Number: CTRI/2022/03/040896
• Lead Sponsor: Sawai Man Singh medical college and atttached hospital

Brief Summary

By studying and comparing the analgesic effect of above mentioned doses of intrathecal nalbuphine as an adjuvant to 0.75% isobaric ropivacaine along with control group in elective lower limb surgeries will help us to be more efficient in providing best anaesthesia possible to  the patient and open up to more research projects.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-14
• Last Update Posted: 2022-07-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patient of either sex.
• Age group between 18 to 60 years.
• Weight of the patient between 40-70 kilograms.
• Height of the patient ≥ 145cm.
• Patients belonging to ASA class I and II.
• Patients undergoing elective lower limb surgery.

Exclusion Criteria

• Patient’s refusal for spinal anaesthesia.
• Uncooperative patients.
• Patients not willing to participate in the study.
• Patients with compromised airway or morbid obesity.
• Patients with contraindications for spinal anesthesia.
• History of convulsion, allergy to the drug used, bleeding disorder, severe neurological deficit.
• Patients with history of hypertension, diabetes mallietus, respiratory, cardiac, hepatic or renal disease (necessitating classification in ASA Class III or above).
• Pregnant patients.
• Patient receiving phenothiazine, hypnotics or other central nervous system depressants.
• •Patients in which spinal anesthesia failed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To access and compare the time duration for need of first rescue dose of analgesic among three groups	At every 2 minutes for initial 10 minutes, 5 minutes for 10-30 minutes then every 10 minutes till surgery ends and then every 30 minutes for 6 hours after giving subarachnoid block.

Secondary Outcome Measures

Name	Time	Method
1.To find out the difference in mean onset time & duration of sensory & motor block between the three groups.	2.To assess & compare hemodynamic parameters (heart rate, mean blood pressure, systolic blood pressure & diastolic blood pressure), sedation score and post-operative visual analogue scale score.

Trial Locations

Locations (1)

SMS Medical college and hospital; 🇮🇳 Jaipur, RAJASTHAN, India

SMS Medical college and hospital

🇮🇳Jaipur, RAJASTHAN, India

Navdeep Chohan

Principal investigator

9855213337

navychohan15@gmail.com