Analgesic Efficacy of Saphenous Nerve Block in Total Knee Replacement

NCT01991288 | Completed Phase 4 DMC

• 1 other identifier: JR-0786-GI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain

Keywords

Total Knee Replacement; Bupivacaine; Levobupivacaine; Saphenous Nerve Block; Local Infiltration Analgesia

Outcome Measures

Primary Outcomes (1)

• Pain on movement at 24 hours time point post operatively

  24 hours hours time point

Secondary Outcomes (8)

• 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

Other Outcomes (1)

• Time to discharge from hospital

  1 week

Study Arms (2)

SNB Saphenous Nerve block

EXPERIMENTAL

Patients received SNB preoperatively at mid thigh level with ultrasound guidance. 10 mls 0.5% bupivacaine was administered for nerve block by the anesthetist. All patients also received peri operative Local Infiltration Analgesia by the surgeon. All patients will receive preoperative oxycontin, peri operative paracetamol and diclofenac. Post operatively all patients received regular paracetamol 1g 6 hourly, Diclofenac sodium 12 hourly and oxycontin 10-20 mg 12 hourly. All patients received standardized spinal block by the same anesthetist, post nerve block for surgery.

Procedure: SNB Saphenous Nerve Block

NSNB Non Saphenous Nerve Block

ACTIVE COMPARATOR

Patients only received Local Infiltration Analgesia. As per protocol all patients received the same pre, peri and post operative analgesia as described in the experimental group. All patients had a standardized spinal block for surgery.

Procedure: NSNB Non Saphenous Nerve Block

Interventions

SNB Saphenous Nerve Block PROCEDURE

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

Also known as: Bupivacaine, Levobupivacaine, Adrenaline, 0.9% NaCl

SNB Saphenous Nerve block

NSNB Non Saphenous Nerve Block PROCEDURE

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

Also known as: Levobupivacaine, Adrenaline, 0.9% NaCl

NSNB Non Saphenous Nerve Block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

Dept. of Anaesthesia & Intensive Care Unit, Cork University Hospital

Cork, Cork, 0000, Ireland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Levobupivacaine; Epinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• George Shorten, FFARCSI, PhD

  Dept. of Anaesthesia & ICU, Cork University Hospital, Cork, Ireland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar

Study Record Dates

• First Submitted: November 17, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

IE (1)