Clinical trial NCT01991288: Analgesic Efficacy of Saphenous Nerve Block in Total Knee Replacement
Official title: Does Saphenous Nerve Block Improve Analgesia After Total Knee Replacement When Used in Combination With Local Infiltration Analgesia? A Prospective Randomised Double Blinded Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: Total Knee Replacement
Bupivacaine
Levobupivacaine
Saphenous Nerve Block
Local Infiltration Analgesia
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain on movement at 24 hours time point post operatively
timeFrame: 24 hours hours time point
Secondary outcomes:
measure: pain on movement at 6 and 12 hour time point
timeFrame: 6 and 12 hours time points
measure: pain at rest at 6, 12 and 24 hours time points
timeFrame: 6, 12 and 24 hours time points
measure: Maximum Knee Flexion at 6, 12 and 24 hours time points
timeFrame: 6, 12 and 24 hours time points
measure: Maximum Straight Leg Raise Test at 6, 12 and 24 hours time points
timeFrame: 6, 12 and 24 hours time points
measure: Time to First request for rescue analgesia
timeFrame: 24 hours
measure: Cumulative Opioid consumption in 24 hours
timeFrame: 24 hours
measure: Cumulative opioid consumption till discharge
timeFrame: till discharge time
measure: 6 Minute walk test
timeFrame: At 24 hours Post block Conduction
Other outcomes:
measure: Time to discharge from hospital
timeFrame: 1 week
Locations:
city: Cork
country: Ireland
facility: Dept. of Anaesthesia & Intensive Care Unit, Cork University Hospital
Study officials:
affiliation: Dept. of Anaesthesia & ICU, Cork University Hospital, Cork, Ireland
name: George Shorten, FFARCSI, PhD
role: STUDY_DIRECTOR
References: