Total Hip Arthroplasty: Multiple Blocks by UltraSound

NCT01276925 | Unknown DMC

• 1 other identifier: BBH-Z-THAMBUS
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

Hip arthroplasty; Peripheral nervous blockade; Postoperative; Pain; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• Pain

  Verbal Rating Scale score (0-10) at rest.

  At intervals during the first 48 hours after surgery

Secondary Outcomes (9)

• Pain

  At intervals during the first 48 hours after surgery

• Opioid consumption

  In intervals during the first 48 hours after surgery

• Bowel movement

  Within the first 48 hours after surgery

• Sedation

  At intervals during the first 48 hours after surgery

• Nausea

  At intervals during the first 48 hours after surgery

Study Arms (3)

B3: Blockade of three nerves

ACTIVE COMPARATOR

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

Drug: Ropivacaine; Device: Ultrasound; Procedure: Peripheral nerve blockade; Procedure: Total hip arthroplasty; Drug: Bupivacaine

B2: Blockade of 2 nerves

ACTIVE COMPARATOR

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; Device: Ultrasound; Procedure: Peripheral nerve blockade; Drug: Saline; Procedure: Total hip arthroplasty; Drug: Bupivacaine

K: Control group

SHAM COMPARATOR

Sham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline.

Device: Ultrasound; Procedure: Peripheral nerve blockade; Drug: Saline; Procedure: Total hip arthroplasty; Drug: Bupivacaine

Interventions

Ropivacaine DRUG

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.

Also known as: Naropin

B3: Blockade of three nerves

Ultrasound DEVICE

All nerve blockades will be performed with ultrasound guidance.

B2: Blockade of 2 nerves; B3: Blockade of three nerves; K: Control group

Peripheral nerve blockade PROCEDURE

All patients will receive injections around the three nerves before surgery.

B2: Blockade of 2 nerves; B3: Blockade of three nerves; K: Control group

Saline DRUG

Isotonic. 10 ml for the femoral nerve.

B2: Blockade of 2 nerves; K: Control group

Total hip arthroplasty PROCEDURE

All patients undergoes total hip arthroplasty.

B2: Blockade of 2 nerves; B3: Blockade of three nerves; K: Control group

Bupivacaine DRUG

5 mg/ml. 3 ml for spinal anaesthesia.

Also known as: Marcain spinal

B2: Blockade of 2 nerves; B3: Blockade of three nerves; K: Control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, DK-2400, Denmark

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Ropivacaine; Ultrasonography; Sodium Chloride; Arthroplasty, Replacement, Hip; Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Birgitte M Krogh, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

• Kenneth Jensen, MD

  Bispebjerg Hospital

  STUDY DIRECTOR

Central Study Contacts

Birgitte M Krogh, MD

CONTACT

+45 50507405; sommanbehager@yahoo.dk

Kenneth Jensen, MD

CONTACT

+45 40259668; usg.pnb@gmail.com

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: PRINCIPAL INVESTIGATOR
• PI Title: MD, BBA

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 14, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 23, 2015

Record last verified: 2015-10

Locations

DK (1)