Study Comparing a Nerve Block With Spinal Opiate to Provide Pain Relief for Hip Replacement Surgery

NCT01217294 | Completed

• 1 other identifier: GN10AN280
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Pain control after hip replacement surgery is important to ensure patient comfort, allow mobilisation, and aid recovery. The investigators propose a simple and pragmatic study comparing two different anaesthetic techniques in the provision of pain relief after hip surgery. Patients will be randomised to receive either spinal anaesthesia containing morphine or spinal anaesthesia without morphine and an ultrasound guided fascia iliaca nerve block. Although morphine is an effective pain killer, its side effects include itch, urinary retention, nausea and potentially fatal breathing problems. If the nerve block can be shown to provide comparable pain relief to spinal morphine, then morphine could be removed from the spinal injection. This could reduce side effects and improve patient safety. The investigators wish to investigate whether ultrasound guided fascia iliaca plane block provides analgesia which is comparable to that of intrathecal opioid for primary hip arthroplasty in the first 24 hours after hip replacement surgery

Conditions

Analgesia

Keywords

anaesthetic techniques, regional; analgesia, post-operative; fascia iliaca compartment block; ultrasound guided; surgery, orthopaedic

Outcome Measures

Primary Outcomes (1)

• Primary outcome will be post-operative morphine consumption in a 24 hour period as self-administered using a patient controlled analgesia (PCA) pump.

  We hypothesise that ultrasound guided fasca iliaca plane block provides analgesia which is comparable to that of intrathecal opioid for primary hip arthroplasty in the first 24 hours after surgery. This study is powered to detect a difference of 10mg of morphine within a 24 hour period. We would consider a dose of 10mg as being significant clinically.

  24 hours

Secondary Outcomes (8)

• Pain scores

  48 hours

• Hypotension

  48 hours

• post-operative nausea and vomiting

  48 hours

• Pruritus

  48 hours

• Sedation

  48 hours

Study Arms (2)

spinal morphine, sham block

SHAM COMPARATOR

Spinal anaesthesia with hyperbaric bupivacaine 10 - 15mg as specified by the anaesthetist performing the spinal injection, and with the addition of intrathecal morphine 100 micrograms. Sham ultrasound guided fascia iliaca plane block with saline. Post-operative analgesia with Paracetamol 1g four times daily, and patient controlled analgesia (PCA) with morphine (1mg bolus, 5 minute lockout period)

Procedure: spinal morphine

ultrasound guided fascia iliaca block

ACTIVE COMPARATOR

Spinal anaesthesia with hyperbaric bupivacaine at a dose between 10 and 15mg as deemed appropriate by the anaesthetic doctor performing the spinal injection, no spinal morphine and fascia iliaca plane block using 2mg/kg levobupivacaine diluted to a total of 40ml with sterile saline. Post-operative analgesia with Paracetamol 1g four times daily, and patient controlled analgesia (PCA) with morphine (1mg bolus, 5 minute lockout period)

Procedure: ultrasound guided fascia iliaca block

Interventions

ultrasound guided fascia iliaca block PROCEDURE

Spinal anaesthesia with hyperbaric bupivacaine at a dose between 10 and 15mg as deemed appropriate by the anaesthetic doctor performing the spinal injection, no spinal morphine and ultrasound guided fascia iliaca plane block using 2mg/kg levobupivacaine diluted to a total of 40ml with sterile saline.

ultrasound guided fascia iliaca block

spinal morphine PROCEDURE

Spinal anaesthesia with hyperbaric bupivacaine 10 - 15mg as deemed appropriate by the anaesthetists performing the spinal injection, and with the addition of intrathecal morphine 100 micrograms. Sham fascia iliaca plane injection with saline.

spinal morphine, sham 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:

• English-speaking
• Competent to give consent
• ASA physical status I - III
• years of age, inclusive
• kg, inclusive
• Scheduled for unilateral primary hip arthroplasty

You may not qualify if:

• Contraindications to fascia iliaca plane block
• Contraindication to spinal anaesthesia
• Coagulopathy, malignancy or infection in the inguinal area
• Patient preference for general anaesthesia
• Allergy to opioids
• Significant peripheral neuropathy or neurologic disorder affecting the lower extremity
• Pregnancy
• History of alcohol or drug dependency / abuse
• History of long term opioid intake
• History of significant psychiatric conditions that may affect patient assessment

Sponsors & Collaborators

• Rachel Kearns: lead
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, Scotland, G312HT, United Kingdom

Location

Related Publications (1)

• Kearns RJ, Macfarlane AJ, Anderson KJ, Kinsella J. Intrathecal opioid versus ultrasound guided fascia iliaca plane block for analgesia after primary hip arthroplasty: study protocol for a randomised, blinded, noninferiority controlled trial. Trials. 2011 Feb 21;12:51. doi: 10.1186/1745-6215-12-51.

  PMID: 21338492 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Kinsella, MBBS MD

  University Section of Anaesthesia, Glasgow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: co-investigator

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 8, 2010
• Study Start: May 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

GB (1)