In lower limb orthopedic surgeries, comparing the intra operative and post operative, pain relief duration and hemodynamic changes with Buprenorphine versus Butorphenol, when given as additive with 0.5 percent levobupivacaine as spinal anaesthesia.

Effectiveness of intrathecal buprenorphine versus butorphanol as adjuvant in 0.5 percent levobupivacaine in lower limb surgeries. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/076067

Enrollment

105

Registered

2024-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system

Interventions

Intervention1: intrathecal buprenorphine versus butorphanol as adjuvant in 0.5% Levobupivacaine in lower limb orthopedic surgeries: Assess the sensory and motor blockade intra-op and post-op after int

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective lower surgeries. 2. Patient within the age group of 18-60 years 3. Patients under ASA I and II

Exclusion criteria

Exclusion criteria: . Patients under ASA III, ASA IV. 2. Patients with coagulation disorders 3. Patient known allergic to local anesthetic agents 4. Skin infection at local sites 5. Patients who are not willing to participate. 6. Any patient with neurological disorder

Design outcomes

Primary

Measure	Time frame
1.Assess the sensory and motor blockade intra operative and post operative after intrathecal Infiltration of 0.5 percent levobupivacaine with adjuvant butorphenol and buprenorphine. 2.To assess the intensity of pain using visual analogue score. 3.Duration of analgesia. 4.Time of first dose of rescue analgesia Timepoint: 2,4,6,8,10,12,14,30,90,120 minutes then 1 hourly until sensory blockade reaches S2 dermatome.	—

Measure

Time frame

1.Assess the sensory and motor blockade intra operative and post operative after intrathecal Infiltration of 0.5 percent levobupivacaine with adjuvant butorphenol and buprenorphine. 2.To assess the intensity of pain using visual analogue score. 3.Duration of analgesia. 4.Time of first dose of rescue analgesia Timepoint: 2,4,6,8,10,12,14,30,90,120 minutes then 1 hourly until sensory blockade reaches S2 dermatome.

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Secondary

Measure	Time frame
Assessment of intra-op effects of above combination 1. Bradycardia 2. Hypotension 3. Sedation 4. Nausea/vomiting 5. Respiratory depression 6. Shivering 7. Dry mouth, pruritis 8. Urinary retention Timepoint: 3 minute interval for first 30 minutes then every 30 minutes then 2 hours post operatively	—

Countries

India

Contacts

Public ContactDr Shaswat Pattnaik

Institute of Medical Sciences and SUM hospital

hod.anaesthesiology.ims@soa.ac.in9938303354

Outcome results

None listed

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