Comperative Evaluation of Intraosseous Regional Analgesia using Diclofenac, Morphine, Lignocaiine and placebo in Bilateral Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To compare the total opioid consumption (in morphine equivalents) in the first 48 hours postoperatively among the four groups.
Overview
Brief Summary
This Phase 2 randomized controlled trial evaluates the efficacy and safety of intraosseous regional analgesia using morphine, lignocaine, and diclofenac in patients undergoing bilateral total knee arthroplasty. Postoperative pain intensity (VAS) and total opioid consumption will be assessed up to 48 hours. The study aims to determine whether this technique provides effective pain control with minimal adverse effects, potentially improving postoperative recovery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 50.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients aged 50–75 years undergoing simultaneous bilateral total knee arthroplasty under spinal anesthesia and epidural analgesia Diagnosed with bilateral end-stage osteoarthritis of the knee ASA (American Society of Anesthesiologists) physical status Class I–III Willing and able to provide informed written consent.
Exclusion Criteria
- •Known allergy or hypersensitivity to lignocaine, morphine, diclofenac, or other NSAIDs Patients with coagulopathy or on anticoagulants that cannot be discontinued History of chronic opioid use, substance abuse, or opioid tolerance Renal or hepatic impairment Active local or systemic infection History of neurological disorders or psychiatric illness affecting pain perception or communication Revision TKA or prior major surgery on either knee If surgery went prolonged more then 4 hrs If during surgery any intraop complication happens.
- •if patient having rhematoid arthritis.
Outcomes
Primary Outcomes
To compare the total opioid consumption (in morphine equivalents) in the first 48 hours postoperatively among the four groups.
Time Frame: To compare the total opioid consumption (in morphine equivalents) in the first 48 hours postoperatively among the four groups.
Secondary Outcomes
- To evaluate & compare the postoperative pain relief provided by intraosseous administration of Diclofenac, Morphine, Lignocaine & Control using standardized pain scores (e.g., Visual Analog Scale) at 6, 12, 24 & 48hrs predefined time intervals.(To evaluate the time to first rescue analgesia postoperatively among the four groups.)
Investigators
Dr Khushwant Meena
PGIMER chandigarh