Analgesic Efficacy of Saphenous Nerve Block in Total Knee Replacement

Post Operative Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991288
• Other study ID #: JR-0786-GI
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2013
• Last updated: November 21, 2013
• Start date: November 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: Cork University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• SNB Saphenous Nerve Block
Patients in group SNB received an ultrasound guided SNB (a sub sartorial approach) by a single operator with 10 mls 0.5% bupivacaine. At the end of surgery periarticular knee infiltration of 30 mls 0.5% levobupivacaine + 70 mls 0.9% saline + 0.5 mg adrenaline was performed in a staged fashion by the surgeon, beginning with infiltration of the deep structures on tibial surface at 1mm depth around all exposed tissues, medial and lateral collateral ligament origin, all cut surfaces of extensor mechanism, all cut surface of skin and subcutaneous tissue
• NSNB Non Saphenous Nerve Block
All patients at the end of surgery received periarticular knee infiltration of 30 mls 0.5% levobupivacaine + 70 mls 0.9% saline + 0.5 mg adrenaline, in a staged fashion by the surgeon, beginning with infiltration of the deep structures on tibial surface at 1mm depth around all exposed tissues, medial and lateral collateral ligament origin, all cut surfaces of extensor mechanism, all cut surface of skin and subcutaneous tissue

Locations

Country	Name	City	State
Ireland	Dept. of Anaesthesia & Intensive Care Unit, Cork University Hospital	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Cork University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to discharge from hospital		1 week	No
Primary	Pain on movement at 24 hours time point post operatively		24 hours hours time point	No
Secondary	pain on movement at 6 and 12 hour time point		6 and 12 hours time points	No
Secondary	pain at rest at 6, 12 and 24 hours time points		6, 12 and 24 hours time points	No
Secondary	Maximum Knee Flexion at 6, 12 and 24 hours time points		6, 12 and 24 hours time points	No
Secondary	Maximum Straight Leg Raise Test at 6, 12 and 24 hours time points		6, 12 and 24 hours time points	No
Secondary	Time to First request for rescue analgesia		24 hours	No
Secondary	Cumulative Opioid consumption in 24 hours		24 hours	No
Secondary	Cumulative opioid consumption till discharge		till discharge time	No
Secondary	6 Minute walk test		At 24 hours Post block Conduction	No