Total Hip Arthroplasty: Multiple Blocks by UltraSound (THAMBUS)

This study is currently recruiting participants.
Verified April 2013 by Bispebjerg Hospital
Sponsor:
Information provided by (Responsible Party):
Jens Borglum Neimann, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01276925
First received: January 13, 2011
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

Patients undergoing total hip arthroplasty may experience severe postoperative pain. This is normally treated with opioids, which can cause side effects such as nausea, vomiting, obstipation and sedation. The hypothesis is that patients receiving peripheral nerve blockade of three nerves leading pain stimuli from the hip will experience less pain, will consume less opioid and therefore have less side effects, and will be mobilized more quickly than patients not receiving the peripheral nerve blockade.


Condition Intervention
Pain, Postoperative
Drug: Ropivacaine
Device: Ultrasound
Procedure: Peripheral nerve blockade
Drug: Saline
Procedure: Total hip arthroplasty
Drug: Bupivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Ultrasound Guided Blockade of the Femoral Nerve, the Anterior Division of the Obturator Nerve, and the Lateral Femoral Cutaneous Nerve on Postoperative Pain, Morphine Consumption, and Mobilization After Total Hip Arthroplasty.

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: At intervals during the first 48 hours after surgery ] [ Designated as safety issue: No ]
    Verbal Rating Scale score (0-10) at rest.


Secondary Outcome Measures:
  • Pain [ Time Frame: At intervals during the first 48 hours after surgery ] [ Designated as safety issue: No ]

    Assessed by:

    • Verbal Rating Scale score (0-10) with passive flexion of the hip.
    • Verbal Rating Scale score (0-10) with active flexion of the hip.

  • Opioid consumption [ Time Frame: In intervals during the first 48 hours after surgery ] [ Designated as safety issue: No ]
  • Bowel movement [ Time Frame: Within the first 48 hours after surgery ] [ Designated as safety issue: No ]

    Assessed by:

    • Time for first stool
    • Number of stools at intervals during the first 48 hours after surgery

  • Sedation [ Time Frame: At intervals during the first 48 hours after surgery ] [ Designated as safety issue: No ]
    Assessed by the Pasero Opioid-induced Sedation Scale (POSS).

  • Nausea [ Time Frame: At intervals during the first 48 hours after surgery ] [ Designated as safety issue: No ]

    Assesed by

    • a verbal scale (none, light, moderate, marked)
    • the consumption of antiemetics

  • Vomiting [ Time Frame: In intervals during the first 48 hours after surgery ] [ Designated as safety issue: No ]
    Number of vomitings, estimated to have exceeded a volume of 10 ml.

  • Mental and physical condition [ Time Frame: Before and at intervals during the first 48 hours after surgery ] [ Designated as safety issue: No ]

    Assessed by:

    • Big Five Inventory, subscales extrovert and neuroticism
    • Modified Barthel Index/100
    • SF-8 index

  • Mobilization [ Time Frame: The first 48 hours after surgery ] [ Designated as safety issue: No ]
    The time at which the patient walks for the first time after surgery.

  • Length of stay [ Time Frame: One week ] [ Designated as safety issue: No ]
    • The time from end of surgery to discharge from the postoperative care unit
    • The time from end of surgery to discharge from the hospital


Estimated Enrollment: 81
Study Start Date: August 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B3: Blockade of three nerves
Peripheral nerve blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with ropivacaine.
Drug: Ropivacaine
7,5 mg/ml. 10 ml for the femoral nerve, 10 ml for the anterior division of the obturator nerve, 5 ml for the lateral femoral cutaneous nerve.
Other Name: Naropin
Device: Ultrasound
All nerve blockades will be performed with ultrasound guidance.
Procedure: Peripheral nerve blockade
All patients will receive injections around the three nerves before surgery.
Procedure: Total hip arthroplasty
All patients undergoes total hip arthroplasty.
Drug: Bupivacaine
5 mg/ml. 3 ml for spinal anaesthesia.
Other Name: Marcain spinal
Active Comparator: B2: Blockade of 2 nerves

Peripheral nerve blockade of the anterior division of the obturator nerve and the lateral femoral cutaneous nerve with ropivacaine.

Sham blockade of the femoral nerve with saline.

Drug: Ropivacaine
7,5 mg/ml. 10 ml for the anterior division of the obturator nerve, 5 ml for the lateral femoral cutaneous nerve.
Other Name: Naropin
Device: Ultrasound
All nerve blockades will be performed with ultrasound guidance.
Procedure: Peripheral nerve blockade
All patients will receive injections around the three nerves before surgery.
Drug: Saline
Isotonic. 10 ml for the femoral nerve.
Procedure: Total hip arthroplasty
All patients undergoes total hip arthroplasty.
Drug: Bupivacaine
5 mg/ml. 3 ml for spinal anaesthesia.
Other Name: Marcain spinal
Sham Comparator: K: Control group
Sham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline.
Device: Ultrasound
All nerve blockades will be performed with ultrasound guidance.
Procedure: Peripheral nerve blockade
All patients will receive injections around the three nerves before surgery.
Drug: Saline
Isotonic. 10 ml for the femoral nerve.
Procedure: Total hip arthroplasty
All patients undergoes total hip arthroplasty.
Drug: Bupivacaine
5 mg/ml. 3 ml for spinal anaesthesia.
Other Name: Marcain spinal

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Minimum 18 years of age
  • Patients scheduled for primary, unilateral hip arthroplasty with spinal anaesthesia
  • Patients who have given their written and informed consent to participation after having understood the content and limitations of the protocol fully
  • ASA 1-3

Exclusion Criteria:

  • Patients who are not able to co-operate
  • Patients who do not speak or understand Danish
  • Daily use of opioids corresponding to 40 mg of morphine daily
  • Allergy towards the drugs used in the study
  • Drug abuse (investigators judgement)
  • Alcohol consumption larger than advised by the Danish National Board of Health
  • Spinal anaesthesia is contraindicated or the patient wants a general anaesthesia
  • Patients in whom the blockade procedure or the spinal anaesthesia procedure cannot be completed because of technical difficulties
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276925

Contacts
Contact: Birgitte M Krogh, MD +44 7428 403635 sommanbehager@yahoo.dk
Contact: Kenneth Jensen, MD +45 35313531 ext 4496 kenneth.jensen@tdc-broadband.dk

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, DK-2400
Contact: Kenneth Jensen, MD    +45 35313531 ext 4496    kenneth.jensen@tdc-broadband.dk   
Contact: Jens B Neimann, PhD, MBA    +45 40260554    jbn@dadlnet.dk   
Sub-Investigator: Kenneth Jensen, MD         
Principal Investigator: Birgitte M Krogh, MD         
Principal Investigator: Jens B Neimann, PhD, MBA         
Sub-Investigator: Katja Lenz, MD         
Sub-Investigator: Jepser Hvolris, MD         
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Birgitte M Krogh, MD Bispebjerg Hospital
Study Director: Kenneth Jensen, MD Bispebjerg Hospital
Principal Investigator: Jens B Neimann, MD Bispebjerg Hospital
  More Information

No publications provided

Responsible Party: Jens Borglum Neimann, MD, PhD, MBA, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01276925     History of Changes
Other Study ID Numbers: BBH-Z-THAMBUS
Study First Received: January 13, 2011
Last Updated: April 10, 2013
Health Authority: Denmark: National Board of Health
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Bispebjerg Hospital:
Hip arthroplasty
Peripheral nervous blockade
Postoperative
Pain
Ropivacaine

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Ropivacaine
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 April 20, 2014