Postoperative Pain Relief Following Total Hip Arthroplasty. A Comparison Between Intrathecal Morphine (IM) and Local Infiltration Analgesia (LIA)

NCT01281891 | Unknown Phase 4 DMC

• 1 other identifier: THA001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain following total hip arthroplasty (THA) (1) is often considered moderate to severe and can therefore influence the postoperative course of event and result in delayed postoperative mobilization and prolonged hospitalization. It is therefore necessary to find the most optimal method for alleviation of pain for these patients. Traditionally, this has been managed by epidural analgesia, continuous peripheral nerve blocks, parental- or spinal opioids. Recently, Drs Kerr and Kohan at the Joint Orthopaedic Centre in Sydney, Australia developed a local infiltration analgesia (LIA) technique. The technique was introduced in Scandinavia during 2001 and has been shown to be efficacious during knee surgery. The LIA technique is based on a systemic infiltration of a mixture of a long-acting local anaesthetic (ropivacaine), a non steroidal anti-inflammatory drug (ketorolac), and epinephrine into the tissue around the surgical field to achieve satisfactory pain control with little physiological disturbance. A catheter is left from the skin and into the joint cavity, allowing repeated injection on the morning after surgery (10). Effective pain relief with early mobilization and reduced hospital stay has been reported following total knee arthroplasty and, recently, following unicompartmental knee arthroplasty. The aim of this study is to assess whether LIA technique is equi-efficacious to intrathecal morphine, the standard of care in our hospital.

Conditions

Primary Osteoarthritis Requiring Total Hip Replacement

Keywords

Drug: Morphine intrathecal; Pain: Postoperative; Surgery: Total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption postoperatively

  Other than total morphine consumption, even pain intensity on movement would be considered to be an important parallel end-point.

  During 0 -24 hours postoperatively

Secondary Outcomes (1)

• Pain intensity (NRS, Numeric Rating Score; 0-10)

  0 - 24 h

Study Arms (2)

Local Infiltration Analgesia

EXPERIMENTAL

Combination of ropivacaine, ketorolac and adrenaline

Drug: LIA

Intrathecal morphine

ACTIVE COMPARATOR

Morphine special (preservative-free) injected intrathecally

Drug: I/T morphine

Interventions

LIA DRUG

Ropivacaine 0.2% Ketorolac 30 mg Adrenaline 0.1 mg/ml

Local Infiltration Analgesia

I/T morphine DRUG

Morphine special 0.1 mg injected intrathecally

Intrathecal morphine

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year-old undergoing total hip arthroplasty.
• ASA I - II (appendix 1).
• Have signed and dated Informed Consent.
• Willing and able to comply with the protocol for the duration of the trial.

You may not qualify if:

• Re-operation of a previous total hip arthroplasty.
• Allergy/intolerance to local anaesthetics, Morphine, Adrenaline, Ketorolac or Ropivacaine.
• Patients with chronic pain who are taking opiate analgesics regularly.
• Major bleeding disorders
• Chronic obstructive pulmonary disease (COPD)
• Severe asthma that is difficult to treat
• Limited breathing capacity due to muscular dystrophy
• Sleep apnoea syndrome
• Other contraindication to spinal anaesthesia such as spinal stenosis, local infection or contraindications to local anaesthetics.
• Participation in another clinical medicinal trial during the last 30 days or where follow-up is not completed.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Örebro University Hospital

Örebro, 70185, Sweden

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 24, 2011
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 12, 2012

Record last verified: 2012-09

Locations

SE (1)