Comparing how two different doses of an additive to bupivacaine heavy modifies the duration of action when used in lower limb surgeries

A Comparative Study Of Two Doses Of Buprenorphine As An Adjuvant To 0.5% Hyperbaric Bupivacaine For Spinal Anesthesia In Lower Limb Surgeries.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039545

Enrollment

Registered

2022-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

Health Condition 1: S899- Unspecified injury of lower leg

Interventions

Intervention1: Spinal Anesthesia: spinal anesthesia is given under all aseptic precautions into the L3 L4 space using 23G quincke spinal needle with 3ml bupivacaine and the two doses of buprenorphine.

Eligibility

Inclusion criteria

Inclusion criteria: All patients from age 18 to 65 belonging to ASA grade 1, 2 or 3 undergoing lower limb surgeries

Exclusion criteria

Exclusion criteria: Contraindications of spinal Anesthesia such as Local infection, raised intra cranial tension, coagulopathy , valvular heart disease Known allergy to the study drugs

Design outcomes

Primary

Measure	Time frame
1) Time of onset of sensory block. 2) Maximum height of sensory block. 3) Duration of sensory block as regression to L1. 4) Time of onset of motor block. 5) Duration of motor block. 6) Duration of post operative analgesia. Timepoint: Sensory block will be tested every 2 min till maximum height of sensory level, Thereafter every 20 min till the block regression to L1 level. Motor block will be tested every 2 mins using Bromage scale till starting of surgery,Thereafter every 20 mins in the post op period till complete recovery (grade 0) and duration of motor block will be noted.	—

Measure

Time frame

1) Time of onset of sensory block. 2) Maximum height of sensory block. 3) Duration of sensory block as regression to L1. 4) Time of onset of motor block. 5) Duration of motor block. 6) Duration of post operative analgesia. Timepoint: Sensory block will be tested every 2 min till maximum height of sensory level, Thereafter every 20 min till the block regression to L1 level. Motor block will be tested every 2 mins using Bromage scale till starting of surgery,Thereafter every 20 mins in the post op period till complete recovery (grade 0) and duration of motor block will be noted.

—

Secondary

Measure	Time frame
Intra operative hemodynamic parameters eg Heart rate & Mean Blood Pressure Side effects such as nausea vomiting, pruritus, urinary retention and respiratory depression Timepoint: Every 2 min for the first 20 min and then every 10 min till the block regression to L1, post operative analgesia every 30 min for the first 2 hours and 2 hourly thereafter.	—

Countries

India

Contacts

Public ContactDR SANHITA JITEN KULKARNI

MGM,MEDICAL COLLEGE AND HOSPITAL , AURANGABAD

drsanhitakulkarni@gmail.com9881300645

Outcome results

None listed

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