Intrathecal Diamorphine Versus Femoral Nerve Block in Primary Total Knee Arthroplasty

NCT ID: NCT01931332

Last Updated: 2013-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-07-31

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).

Detailed Description

In 2008, the Prospect Working Group, a multidisciplinary expert panel, published their consensus guidelines on the relative merits of different anaesthetic and analgesic techniques for TKA based on a review of the available published literature up to 2005. These guidelines supported the use of general anaesthesia combined with a femoral nerve block for surgery and postoperative analgesia, or alternatively spinal anaesthesia with local anaesthetic combined with spinal morphine. The preference for femoral nerve block in favour of intrathecal opiates was as a consequence of the greater potential for side effects with the latter technique. The authors conceded that there were a lack of well-conducted studies on this subject, graded their recommendations as level D (expert opinion), and concluded further research was needed. Consequently there has been debate around the conclusions drawn and clinicians have not universally accepted the recommendations.

Most researchers to date have focused on short-term outcomes such as static pain scores and/or opiate consumption. It is also important however to investigate dynamic pain scores, patient reported outcomes, the attainment of rehabilitation goals, length of stay and longer term functional outcomes. In addition, the use of the total pain relief score (TOTPAR) as described by Cooper and Beaver, assesses the cumulative response to treatment. This is a well validated area under the time-analgesic effect curve (AUC) derivation for pain relief which is commonly used by meta-analyses of analgesic interventions. The aim of this study is to investigate all these endpoints in patients receiving a single-shot femoral nerve block (FNB) for TKA as compared to intrathecal diamorphine (ID), a more commonly used spinal opiate in United Kingdom anaesthetic practice.

Conditions

Osteoarthritis

Keywords

Arthroplasty; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Femoral Nerve Block with levobupivicaine

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

Group Type: ACTIVE_COMPARATOR

Femoral Nerve Block with levobupivicaine

Intervention Type: 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

Intrathecal injection of diamorphine

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

Group Type: ACTIVE_COMPARATOR

Intrathecal injection of diamorphine

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Intrathecal injection of diamorphine

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult patients scheduled for primary unilateral Total Knee Arthroplasty

Exclusion Criteria

• 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).

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Devon and Exeter NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Matthew Grayling

Consultant Anaesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Grayling, MBBS

Role: PRINCIPAL_INVESTIGATOR

Royal Devon and Exeter Hospital

Locations

Royal Devon and Exeter Hospital

Exeter, Devon, United Kingdom

Countries

United Kingdom

Other Identifiers

10/H0202/1

Identifier Type: -

Identifier Source: org_study_id