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A Study on Patients Undergoing Knee Replacement to See Whether Injecting Pain Medicine into the Bone During Surgery Reduces Pain After the Operation

Comperative Evaluation of Intraosseous Regional Analgesia using Diclofenac, Morphine, Lignocaiine and placebo in Bilateral Total Knee Arthroplasty: A Prospective Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105355
Enrollment
60
Registered
2026-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Interventions

Intervention1: Evaluation of Intraosseous Regional Analgesia in Bilateral Total Knee Arthroplasty : Intraosseous Regional Analgesia (IO RA) will be administered into the proximal tibia of patients und

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To compare the total opioid consumption (in morphine equivalents) in the first 48 hours postoperatively among the four groups.Timepoint: To compare the total opioid consumption (in morphine equivalents) in the first 48 hours postoperatively among the four groups.—

Secondary

MeasureTime frame
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. To monitor & compare the incidence of adverse effects (e.g., nausea, vomiting, sedation, allergic reactions, local complications).Timepoint: after 48 hrs over the course of the study—

Countries

India

Contacts

Public ContactDr Vikas Bachhal

PGIMER chandigarh

vikasbachhal@gmail.com7087928664

Outcome results

None listed

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