Study to Test the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
Orthopaedic Research and Innovation Foundation
ClinicalTrials.gov Identifier:
NCT01106001
First received: April 12, 2010
Last updated: April 16, 2010
Last verified: July 2008
  Purpose

The hypothesis of this study is that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control. Patients were randomised in the operating room to receive either a periarticular infiltration, or a placebo consisting of Saline. Morphine and analgesic consumption was recorded for each patient, while the modified McGill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45 patients in the treatment group and 46 controls. The results were assessed after one year, once all the information from both treatment groups was collected.


Condition Intervention Phase
Osteoarthritis
Drug: Levobupivacaine
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Control Trial on the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Orthopaedic Research and Innovation Foundation:

Primary Outcome Measures:
  • To determine a significant difference (p>0.05) in morphine consumption between the two treatment groups post-operatively. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The modified McGill pain scale was administered to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. In addition, morphine and analgesic consumption was recorded for each patient. The results were assessed after one year, once all the information from both treatment groups was collected.


Secondary Outcome Measures:
  • To analyse the length of stay for between both treatment groups [ Time Frame: Average 6 days (based on precise day of discharge) ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levobupivacaine
Levobupivacaine is indicated for local anaesthesia including infiltration, nerve block, ophthalmic, epidural and intrathecal anaesthesia in adults; and infiltration analgesia in children
Drug: Levobupivacaine
The treatment group received 150mg of levobupivicaine in 60mls of 0.9% saline. This was injected intra-operatively through the medial and anterior capsular spaces in the region of the obturator and femoral nerves and also around the short rotators and gluteus maximus in the region of the inferior and superior gluteal nerves. The timing of this was after insertion of the acetabular component. 10mls was then infiltrated around the tensor fascia lata and subcutaneously prior to closing the wound.
Placebo Comparator: Saline
Saline (also saline solution) is a general term referring to a sterile solution of sodium chloride (NaCl, more commonly known as salt) in water but is only sterile when it is placed intravenously, otherwise, a saline solution is a salt water solution.
Drug: Saline
The placebo group received 60mls of 0.9% saline injected intra-operatively through the medial and anterior capsular spaces in the region of the obturator and femoral nerves and also around the short rotators and gluteus maximus in the region of the inferior and superior gluteal nerves. The timing of this was after insertion of the acetabular component. 10mls was then infiltrated around the tensor fascia lata and subcutaneously prior to closing the wound.

Detailed Description:

The efficacy of periarticular injections during total knee arthroplasty is well established but there is little published data on their effect in primary hip arthroplasty. We hypothesized that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control. A double blinded, randomised, placebo-controlled trial on patients undergoing primary hip arthroplasty was performed. Patients were randomised in theatre to receive either a periarticular infiltration of 150mg levobupivicaine in 60mls of 0.9% Saline, or a placebo consisting of 60mls 0.9% Saline. Morphine and analgesic consumption was recorded for each patient, while the modified McGill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45 patients in the treatment group and 46 controls. The results were assessed after one year, once all the information from both treatment groups was collected.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients undergoing primary hip arthroplasty for osteoarthritis only were included in this study after giving informed consent.

Exclusion Criteria:

  • Patients with cognitive impairment, neurological disorders, advanced liver or renal impairment, known ischemic heart disease, a previous diagnosis of a pain syndrome or any post-operative surgical or medical complications were excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106001

Locations
Ireland
Cappagh National Orthopaedic Hospital
Dublin, Finglas, Ireland, Dublin 11
Orthopaedic Research and Innovation Foundation
Dublin, Santry, Ireland, Dublin 9
Sponsors and Collaborators
Orthopaedic Research and Innovation Foundation
Investigators
Principal Investigator: Kevin J Mulhall Orthopaedic Research and Innovation Foundation
  More Information

Publications:

Responsible Party: Prof Kevin Mulhall, Orthopaedic Research and Innovation Foundation
ClinicalTrials.gov Identifier: NCT01106001     History of Changes
Other Study ID Numbers: KM-042008-014
Study First Received: April 12, 2010
Last Updated: April 16, 2010
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by Orthopaedic Research and Innovation Foundation:
total hip arthroplasty
periarticular injection
pain

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014