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Clinical Trials/CTRI/2024/08/072985
CTRI/2024/08/072985
Not yet recruiting
Phase 3 4

To study the analgesic effectiveness of anterior femoral cutaneous nerve block in addition to proximal adductor canal block and local infiltration analgesia in patients undergoing unilateral primary total knee arthroplasty: A randomised controlled trial

AIIMS New Delhi1 site in 1 country70 target enrollmentStarted: September 4, 2024Last updated:

Overview

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
AIIMS New Delhi
Enrollment
70
Locations
1
Primary Endpoint
Cumulative postoperative analgesic consumption in 36 hours as IV morphine equivalents

Overview

Brief Summary

Total knee arthroplasty (TKA) is commonly conducted surgery and about 2.5 lakh people undergo TKR in India every year. Failure to provide adequate analgesia may affect physical rehabilitation, which is important to improve joint range of motion and promote satisfactory results.Various different peripheral nerve blockade techniques such as sciatic nerve block, obturator nerve block which anaesthetize the posterior part of knee, femoral nerve block and adductor canal block taking care of the anteromedial aspect of knee and obturator nerve block have been described.Femoral nerve block caused motor blockade of the quadriceps femoris muscle so to overcome this motor sparing adductor canal block was given.In order to cover the posterior aspect of knee, infiltration between the popliteal artery and capsule of the knee (IPACK) was introduced and combination of ACB with IPACK was preferredThe advent of local infiltration anaesthesia which is given around the knee involving the medial and lateral remnants, posterior capsule found noninferior to IPACK.So, the standard block preferred for TKR is ACB+LIA. Though ACB+LIA is better it cannot cover the anterior or anteromedial skin incision of the TKR surgery as the dermatomal distribution of this area is supplied by Anterior cutaneous femoral nerve. So, we hypothesize that, additional Anterior femoral cutaneous block, along with proximal ACB and LIA, will empower analgesia and will reduce the opioid consumption and improves postoperative recovery.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA I+II+III 2) 18 TO 70 Years 3) Patients undergoing unilateral primary Total knee arthroplasty.

Exclusion Criteria

  • 1.Patient refusal 2.Varus valgus deformity > 20 degree 3.Flexion deformity > 30 degree 4.BMI > 30 kg/sq.cm 5.Contraindication to neuraxial anaesthesia 6.Allergy to local anaesthetics, NSAIDS, Opioids 7.Chronic opioid use > 3 month duration 8.Previous knee surgery 9.Pregnant females at the time of recruitment 10.Progressive neurological deficit in femoral, obturator or sciatic nerve distribution.
  • 11.Severe cardiac co-morbidities, hepatic or renal dysfunction, coagulopathy.

Outcomes

Primary Outcomes

Cumulative postoperative analgesic consumption in 36 hours as IV morphine equivalents

Time Frame: 36 hours

Secondary Outcomes

  • 1.Numeric rating scale of pain (0 minimum-10 worst pain) at various intervals(2.NRS at movement after mobilization at various time intervals)

Investigators

Sponsor
AIIMS New Delhi
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Debesh Bhoi

AIIMS New Delhi

Study Sites (1)

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