Comparison of pain relief using local anesthetic with opioid morphine or using local anesthetic with another analgesic clonidine or using local anesthetic alone in knee joint scopy followed by ligament tear reconstruction surgeries

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/03/012745
• Date of registration: 22-03-2018
• Prospective Registration: No
• Primary sponsor: Vijayalakshmi Sivapurapu
• Public title: Comparison of pain relief using local anesthetic with opioid morphine or using local anesthetic with another analgesic clonidine or using local anesthetic alone in knee joint scopy followed by ligament tear reconstruction surgeries
• Scientific title: Comparative study of analgesic efficacy of intraarticular bupivacaine+morphine and bupivacaine+clonidine with that of bupivacaine alone for arthroscopic anterior cruciate ligament reconstruction - ACLStudy
• Date of first enrolment: 01-04-2013
• Target sample size: 51
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5995
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Vijayalakshmi Sivapurapu
• Affiliation: Pondicherry Institute of Medical Sciences

• Name: Vijayalakshmi Sivapurapu
• Affiliation: Pondicherry Institute of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: American Society of Anaesthesiologists class I & II patients
Exclusion criteria: Patients with history of allergy to any of drugs used, patients who are not consenting

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: S835- Sprain of cruciate ligament of knee

Intervention(s)

Intervention1: 25ml of 0.25% Bupivacaine with 5mg morphine intraraticular: Local anesthetic with opioid
Intervention2: 25ml of 0.25% Bupivacaine with 150mcg clonidine intraarticular: Local anesthetic with alpha agonist
Control Intervention1: 25ml of 0.25% Bupivacaine intraarticular: Local anesthetic

Primary Outcome(s)

To compare the total duration of analgesia (time to first request for rescue analgesia)Timepoint: To compare the total duration of analgesia (time to first request for rescue analgesia by the patient from the time of administration of intraarticular drug)

Secondary Outcome(s)

24 hour analgesic consumptionTimepoint: 24hours

Hemodynamics like heart rate, blood pressure, pulseoximetry saturation, respiratory rateTimepoint: At 2 & 4 hours after drug administration

To compare visual analog score for patients at rest and on movement (straight leg raise)Timepoint: At 2, 4, 6, 12 & 24 hours from the time of drug administration

Side effects if anyTimepoint: Over 24 hours

To compare visual analog score of patientsTimepoint: At first request for rescue analgesic

Secondary ID(s)

NIL

Source(s) of Monetary Support

Pondicherry Institute of Medical Sciences

Ethics review

Status: Approved
Approval date: 12/05/2014
Contact:

Pondicherry Institute of Medical Sciences Research and Ethics Committee

Results

• Date Completed: 05/01/2016