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Clinical Trials/NCT01991288
NCT01991288
Completed
Phase 4

Does Saphenous Nerve Block Improve Analgesia After Total Knee Replacement When Used in Combination With Local Infiltration Analgesia? A Prospective Randomised Double Blinded Trial.

Cork University Hospital1 site in 1 country20 target enrollmentNovember 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Post Operative Pain
Sponsor
Cork University Hospital
Enrollment
20
Locations
1
Primary Endpoint
Pain on movement at 24 hours time point post operatively
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

We hypothesize that preoperative saphenous nerve block (SNB) in combination with periarticular local infiltration provides better post operative pain relief (POPR) profile as compared to local infiltration alone

Detailed Description

Introduction: Local infiltration analgesia (LIA) is considered acceptable after total knee replacements (TKR) in terms of analgesia, ease of performance, early mobilization and early hospital discharge . Continuous femoral nerve block has been used to enhance post op pain relief (POPR) for TKR but at the expense of motor blockade . A Sub sartorial approach to saphenous nerve block (SNB) spares the motor block . To date the role of saphenous nerve block for POPR in TKR has not been evaluated. Methodology: In order to test this hypothesis, we proposed to carry out a prospective randomized controlled double blinded (surgeon and assessor) trial study. With institutional ethics approval and having obtained written informed consent from each patient, 20 ASA 1 - 3 patients scheduled to undergo TKR under spinal anesthesia +/- sedation were allocated to one of two groups i.e. Group (SNB): patients receiving SNB sub sartorial approach and Group (NSNB): patients not receiving SNB. Group allocation was determined using computer generated random number tables. Sealed envelopes were opened on the day of the surgery by the attending anesthetist responsible for the care of the recruited patient. Postoperative period: Patients were then assessed for pain at rest and on movement on arrival in recovery and then at 6 , 12 and 24 hrs. Visual analogue scale on a 10 cm straight line was used to assess postoperative pain scores as predictive value of post operative analgesia on rest and movement i.e passive flexion of knee to 30 degree . Patients were assessed for any motor block by using maximum tolerable range of active knee flexion (MKF) and maximum range of straight leg raise(MSLR) on arrival in recovery and at 6, 12 and 24 hrs. All patients received regular paracetamol 1g 6 hourly, diclofenac 75 mg 12 hourly, oxycontin 10-20 mg ( depending on age) 12 hourly and oxynorm 10 mg as rescue analgesia.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

DR. Jassim Rauf

Specialist Registrar

Cork University Hospital

Eligibility Criteria

Inclusion Criteria

  • American Society of Anaesthesia (ASA) Grade I-lll patients Undergoing elective Total Knee Arthroplasty Patients able to consent and understand all the components of the study.

Exclusion Criteria

  • Demented patients Patients having bilateral Knee Replacements Patients unable to comprehend the use of pain scales Allergy to any of the medications used in the study Renal dysfunction Coagulation disorders Peptic ulcer disease precluding use of non-steroidal anti-inflammatory drugs (NSAIDs) Patients unable to use regular opioid medication Any chronic pain condition other than osteoarthritis of the knee.

Outcomes

Primary Outcomes

Pain on movement at 24 hours time point post operatively

Time Frame: 24 hours hours time point

Secondary Outcomes

  • pain on movement at 6 and 12 hour time point(6 and 12 hours time points)
  • pain at rest at 6, 12 and 24 hours time points(6, 12 and 24 hours time points)
  • Maximum Knee Flexion at 6, 12 and 24 hours time points(6, 12 and 24 hours time points)
  • Maximum Straight Leg Raise Test at 6, 12 and 24 hours time points(6, 12 and 24 hours time points)
  • Time to First request for rescue analgesia(24 hours)
  • Cumulative Opioid consumption in 24 hours(24 hours)
  • Cumulative opioid consumption till discharge(till discharge time)
  • 6 Minute walk test(At 24 hours Post block Conduction)

Study Sites (1)

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