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

NCT ID: NCT01217294

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-04-30

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

Detailed Description

There were 6312 primary hip replacements performed in Scotland during the one year period 2007 - 2008. Patients undergoing hip arthroplasty commonly have significant comorbidity and associated polypharmacy providing many potential challenges for the anaesthetic doctor. The optimal way to anaesthetise these patients remains to be fully established although many potential methods exist. The main choice is between general anaesthesia (GA) and regional anaesthesia (RA) or a combination of the two. In a recent systematic review, RA was found to reduce post-operative pain, morphine consumption and nausea and vomiting compared with systemic analgesia.

Spinal anaesthesia is a popular form of RA used in many patients undergoing hip arthroplasty. Opioid drugs are frequently added to the spinal injection in order to prolong post-operative pain relief. However, this is associated with side effects including respiratory depression, urinary retention, nausea and vomiting, and pruritus. Such adverse effects may be uncomfortable for the patient and can delay mobilisation, recovery and eventual discharge.

In patients undergoing hip arthroplasty, peripheral nerve blockade has been shown to improve pain scores and reduce morphine consumption. A peripheral nerve block called the fascia iliaca plane block has shown significant promise as a method of providing sensory blockade of the main nerves which supply pain to the hip. The use of ultrasound for the performance of fascia iliaca plane block has been shown to increase reliability compared with the landmark technique though the clinical benefits of this have not yet been fully investigated.

Compared to nerve stimulation or landmark techniques of nerve localisation, ultrasound has been shown to increase success rates, reduce block onset time, increase block duration, reduce volumes of local anaesthetic required and increase patient satisfaction.

The investigators hypothesise that by increasing the success rate of the fascia iliaca block with ultrasound, it will be possible to achieve superior analgesia post-operatively. Our aim is to assess whether the ultrasound guided fascia iliaca plane block can be used as an alternative to intrathecal morphine in the provision of post-operative analgesia for primary hip arthroplasty. If this is the case, intrathecal opioid could be removed from the spinal anaesthetic. This could in theory have significant safety benefits whilst also reducing side effects. Ultrasound guided fascia iliaca block has not yet been evaluated clinically as a method of providing post-operative analgesia following primary hip arthroplasty. The investigators believe that further investigation of this technique will provide a valuable contribution to existing knowledge and will change current practice.

Conditions

Analgesia

Study Design

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

Study Groups

spinal morphine, sham block

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)

Group Type: SHAM_COMPARATOR

spinal morphine

Intervention Type: 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.

ultrasound guided fascia iliaca block

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)

Group Type: ACTIVE_COMPARATOR

ultrasound guided fascia iliaca block

Intervention Type: 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.

Interventions

ultrasound guided fascia iliaca block

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.

Intervention Type: PROCEDURE

spinal morphine

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• English-speaking
• Competent to give consent
• ASA physical status I - III
• 18-85 years of age, inclusive
• 50-110 kg, inclusive
• Scheduled for unilateral primary hip arthroplasty

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: collaborator

Rachel Kearns

OTHER

Sponsor Role: lead

Responsible Party

Rachel Kearns

co-investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Kinsella, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

University Section of Anaesthesia, Glasgow University

Locations

Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 21338492 (View on PubMed)

Other Identifiers

GN10AN280

Identifier Type: -

Identifier Source: org_study_id