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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

Analgesic effect of intrathecal two different doses of nalbuphine 0.8mg versus 1.6 mg as an adjuvant to 0.75% isobaric ropivacaine for elective lower limb surgeries: a randomized double blind controlled interventional study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/040896
Enrollment
90
Registered
2022-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Health Condition 1: M849- Disorder of continuity of bone, unspecified

Interventions

Intervention1: injection 0.75% isobaric ropivacaine 15mg: Intrathecal 2ml of 0 .75% isobaric ropivacaine + 0.5ml normal saline (Total volume 2.5 ml). Control Intervention1: injection nalbuphine 0.8mg:

Sponsors

Sawai Man Singh medical college and atttached hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Patientâ??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.

Design outcomes

Primary

MeasureTime frame
To access and compare the time duration for need of first rescue dose of analgesic among three groupsTimepoint: 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

MeasureTime frame
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. 3.To find out & compare the proportion of cases with side effects and complicationsTimepoint: 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.—

Countries

India

Contacts

Public ContactDr Navdeep Chohan

Sawai Man Singh medical college and atttached hospitals

sunitameena98@gmail.com9461290011

Outcome results

None listed

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