Intrathecal Diamorphine Versus Femoral Nerve Block in Primary Total Knee Arthroplasty

NCT01931332 | Completed DMC

• 1 other identifier: 10/H0202/1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Primary total knee arthroplasty (TKA) is commonly associated with moderate to severe early post-operative pain. The primary aim of this study was to investigate the impact of either a single-shot femoral nerve block (FNB) or intrathecal diamorphine (ID) on post-operative pain after TKA The Null Hypothesis is that there is no difference in the post operative pain relief provided for TKA by a single-shot femoral nerve block (FNB) as compared to intrathecal diamorphine (ID).

Conditions

Osteoarthritis

Keywords

Arthroplasty; Analgesia

Outcome Measures

Primary Outcomes (1)

• Median pain score (NRS: see below) at rest

  Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) assessed at times 3, 6, 12, 24, 48 and 72 hrs postoperatively.

  Over 72 hours post operatively

Secondary Outcomes (13)

• Pain on movement

  At 3 hrs postoperatively

• Pain on movement

  At 6 hrs postoperatively

• Pain on movement

  At 12 hrs postoperatively

• Pain on movement

  At 24 hrs postoperatively

• Pain on movement

  At 48 hrs postoperatively

Other Outcomes (4)

• Quality of recovery score 40

  Day 2 post operatively

• Total Pain Relief Score (TOTPAR)

  Day 1,2 and 3 post-operatively

• Functional health outcome measure

  At 6 weeks post-operatively

Study Arms (2)

Femoral Nerve Block with levobupivicaine

ACTIVE COMPARATOR

A single injection femoral nerve block (FNB) was performed in the supine position with a 50mm insulated needle (NanoLine, Pajunk, Geisingen, Germany) and peripheral nerve stimulator set at 1Hertz (Hz) with pulse width 0.1ms. Once a quadriceps muscle twitch was identified at a stimulated current between 0.2 and 0.5milliamperes (mA), 20mls of 0.375% levobupivacaine (75mg) was injected in fractionated amounts after negative aspiration

Procedure: Femoral Nerve Block with levobupivicaine

Intrathecal injection of diamorphine

ACTIVE COMPARATOR

500mcg of intrathecal diamorphine (ID) (dissolved in 0.5mls normal saline)

Procedure: Intrathecal injection of diamorphine

Interventions

Femoral Nerve Block with levobupivicaine PROCEDURE

A single injection femoral nerve block (FNB) performed in the supine position with a 50mm insulated needle (NanoLine, Pajunk, Geisingen, Germany) and peripheral nerve stimulator set at 1Hz with pulse width 0.1ms. Once a quadriceps muscle twitch is identified at a stimulated current between 0.2 and 0.5mA, 20mls of 0.375% levobupivacaine (75mg) is injected in fractionated amounts after negative aspiration

Femoral Nerve Block with levobupivicaine

Intrathecal injection of diamorphine PROCEDURE

500mcg of intrathecal diamorphine (ID) (dissolved in 0.5mls normal saline)

Intrathecal injection of diamorphine

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients scheduled for primary unilateral Total Knee Arthroplasty

You may not qualify if:

• Uni-compartmental surgery, bilateral surgery, contra-indication to spinal anaesthesia or peripheral nerve block (anticoagulation, hydrocephalus, raised intracranial pressure), allergy to local anaesthetics or diamorphine, malignant hyperthermia or other concerns over general anaesthesia, chronic opiate use and chronic pain medication use (e.g. gabapentin, pregabalin, amitriptyline).

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

Royal Devon and Exeter Hospital

Exeter, Devon, EX1 2ED, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Agnosia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Grayling, MBBS

  Royal Devon and Exeter Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 29, 2013
• Study Start: February 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

GB (1)