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Intrathecal Diamorphine Versus Femoral Nerve Block in Primary Total Knee Arthroplasty

NCT01931332 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-08-29

No results posted yet for this study

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

Interventions

PROCEDURE

Femoral Nerve Block with levobupivicaine

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

PROCEDURE

Intrathecal injection of diamorphine

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

Sponsors & Collaborators

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Matthew Grayling, MBBS · Royal Devon and Exeter Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01931332 on ClinicalTrials.gov