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Comparision of two different doses of buprenorphine as add on to levobupivacaine in arthroscopic lower limb surgeries:A randomized double-blind study

Comparision of two different doses of intrathecal buprenorphine as adjuvants to levobupivacaine in arthroscopic lower limb surgeries:A randomized double-blind study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066084
Enrollment
96
Registered
2024-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: Group LB1-Group L-0.5 % Levobupivacaine with 60 mcg inj Buprenorphine: Patients will receive 0.5% hyperbaric levobupivacaine 2.8 ml with 60 mcg in subarachnoid space through spinal nedd

Sponsors

Dr Vivek Sharma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA Class I/II undergoing arthroscopic lower limb surgeries under subarachnoid block

Exclusion criteria

Exclusion criteria: o H/o hypersensitivity reaction to local anaesthetics o Uncontrolled hypertension, diabetes mellitus and morbid obesity o Contraindication to spinal anaesthesia. o History of alcohol or drug abuse and patients on Chronic opioid o Patient not giving consent o Patients undergoing emergency surgery o Pregnant and lactating females

Design outcomes

Primary

MeasureTime frame
To compare duration of analgesia- Time from intrathecal injection till administration of first rescue analgesic for 24 hoursTimepoint: To compare duration of analgesia- Time from intrathecal injection till administration of first rescue analgesic for 24 hours

Secondary

MeasureTime frame
1-To compare the time taken for onset of sensory block Time taken from the end of injection to loss of pin prick sensation at T10 dermatome 2-To compare the time taken for onset of motor block -The time taken to achieve a score of 2 on the modified Bromage scale. [9] 3-To compare the duration of sensory block- It will be two-segment regression time from highest level of sensory blockade. 4-To compare the duration of motor block- The duration of the motor block will be defined as the time interval between the onset of motor block (modified Bromage scale 2) to the achievement of modified Bromage scale 6 after the surgery. Safety outcome- Recording and reporting of adverse events(nausea,vomiting,respiratory depression) will be collected Timepoint: intraoperative and postoperative

Countries

India

Contacts

Public ContactDr Vivek Sharma

All India Institute of Medical Sciences,Gorakhpur

drvijeta86gsvm@gmail.com9451614415

Outcome results

None listed

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