AzTrials
AzTrials

Pain, PostoperativeTHAMBUSNCT01276925

Total Hip Arthroplasty: Multiple Blocks by UltraSound

A study testing Ropivacaine, Ultrasound and Peripheral nerve blockade in people with Pain, Postoperative, run by Bispebjerg Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Postoperative
What is being tested?
Ropivacaine, Ultrasound and Peripheral nerve blockade
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
1 siteDenmark
Study dates
Aug 2011to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Birgitte M Krogh, MD contact

+45 50507405

sommanbehager@yahoo.dk

Kenneth Jensen, MD contact

+45 40259668

usg.pnb@gmail.com

Denmark1 site, 1 recruiting
  • Bispebjerg Hospital

    Copenhagen, DK-2400

    Kenneth Jensen, MD, +45 40259668, usg.pnb@gmail.com

    B

    Recruiting

Other trials in Denmark

About this study

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.

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.

Read the detailed description

Total hip arthroplasty (THA) may cause significant postoperative pain. The patients are often elderly, and frequently have other diseases or ailments. Postoperative pain treatment must focus on effective pain relief, keeping adverse effects to a minimum, enhancing physical rehabilitation and reducing postoperative morbidity.

Postoperative pain after hip surgery can be treated in different ways; i.e. paracetamol, NSAIDs, opioids, peripheral nerve blocks and epidural catheter. The choice seems to be influenced by local experience, education and personal preferences. Frequently, a multimodal approach is used with a combination of weak analgetics, opioids and maybe regional anaesthetic techniques.

The sensory innervation of the hip is through branches from the lumbar and sacral plexuses. The femoral nerve (FN), the obturator nerve (anterior branch) (ONA) and the lateral femoral cutaneous nerve (LCFN) all stem from the lumbar plexus. The FN and ONA directly supply the hip joint. LCFN innervates the skin on the lateral part of the thigh, where the incision for THA is often made.

The psoas compartment block provides good pain relief after THA, but the block can be associated with more frequent complications than other regional blockades for the lower extremity. Furthermore, the technique is difficult, and requires sub-specialized anaesthetists. In addition, it is often necessary to use electrical nerve stimulation together with ultrasound guidance to achieve a sufficient block.

Blockade of the FN is standard for hip fractures in our hospital, but not standard for THA. Because of the analgetic effect in hip fractures, the PROSPECT group recommends blockade of FN for THA as well, though specific evidence is scarce on the subject.

Blockade of the obturator nerve has been shown to provide pain relief for the hip joint, although the findings are not consistent, probably because of the varying innervation of the hip. The nerve is difficult to locate blindly, and location by nerve stimulator can be uncomfortable for the patient. Furthermore, the anatomic variations of the nerve and its branches is quite substantial.

Previously, nerves were located by surface anatomic landmarks or by nerve stimulation. In the past 6-7 years, the use of ultrasound guidance has become an increasingly effective aid for applying peripheral nerve blockades with continuingly improving technology.

Ultrasound-guided blockade of the three nerves (FN, ONA and LFCN) for postoperative pain treatment for THA is to our knowledge not previously described in the literature. From our knowledge of the anatomic course of the nerves, the investigators assume that the blockades can provide effective pain relief in this clinical context.

Our aim in this trial is to study the effect of ultrasound-guided periferal nerve blockade of the femoral nerve, the obturator nerve (anterior branch), and the lateral femoral cutaneous nerve on postoperative pain, opioid consumption and mobilization after THA.

The investigators want to describe the effect of blockade of the three nerves on pain, compared to placebo (injections with a well-known local analgesic drug compared to injections with isotonic saline).

Because it is desirable to have the patient mobilized as quickly as possible after operation, it seems optimal to cause as little motor blockade as possible. The investigators therefore also want to investigate whether pain relief with blockade of ONA and LCFN without blockade of FN is better than or equal to placebo.

The investigators want to study the possible differences in adverse effects, including motor blockade, between the groups with active nerve blockades, with and without blockade of FN.

Being tested
Ropivacaine, Ultrasound, Peripheral nerve blockade, Saline, Total hip arthroplasty
Keywords
Hip arthroplasty, Peripheral nervous blockade, Postoperative, Pain, Ropivacaine
Medical subject headings
Pain, Postoperative, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivacaineDrug

    Also called Naropin

    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.

  • RopivacaineDrug

    Also called Naropin

    7,5 mg/ml. 10 ml for the anterior division of the obturator nerve, 5 ml for the lateral femoral cutaneous nerve.

  • UltrasoundDevice

    All nerve blockades will be performed with ultrasound guidance.

  • Peripheral nerve blockadeProcedure or surgery

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

  • SalineDrug

    Isotonic. 10 ml for the femoral nerve.

  • Total hip arthroplastyProcedure or surgery

    All patients undergoes total hip arthroplasty.

  • BupivacaineDrug

    Also called Marcain spinal

    5 mg/ml. 3 ml for spinal anaesthesia.

Study groups in NCT01276925
Study groupRoleWhat they receive
B3: Blockade of three nervesActive comparatorPeripheral nerve blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with ropivacaine.
Receives: Drug: Ropivacaine; Device: Ultrasound; Procedure: Peripheral nerve blockade; Procedure: Total hip arthroplasty; Drug: Bupivacaine
B2: Blockade of 2 nervesActive comparatorPeripheral 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.
Receives: Drug: Ropivacaine; Device: Ultrasound; Procedure: Peripheral nerve blockade; Drug: Saline; Procedure: Total hip arthroplasty; Drug: Bupivacaine
K: Control groupSham comparatorSham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline.
Receives: Device: Ultrasound; Procedure: Peripheral nerve blockade; Drug: Saline; Procedure: Total hip arthroplasty; Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain

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

    Measured: At intervals during the first 48 hours after surgery

Secondary outcomes (9)
  1. Pain

    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.

    Measured: At intervals during the first 48 hours after surgery

  2. Opioid consumption

    Measured: In intervals during the first 48 hours after surgery

  3. Bowel movement

    Assessed by:

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

    Measured: Within the first 48 hours after surgery

  4. Sedation

    Assessed by the Pasero Opioid-induced Sedation Scale (POSS).

    Measured: At intervals during the first 48 hours after surgery

  5. Nausea

    Assesed by

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

    Measured: At intervals during the first 48 hours after surgery

  6. Vomiting

    Number of vomitings, estimated to have exceeded a volume of 10 ml.

    Measured: In intervals during the first 48 hours after surgery

  7. Mental and physical condition

    Assessed by:

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

    Measured: Before and at intervals during the first 48 hours after surgery

  8. Mobilization

    The time at which the patient walks for the first time after surgery.

    Measured: The first 48 hours after surgery

  9. Length of stay

    • The time from end of surgery to discharge from the postoperative care unit
    • The time from end of surgery to discharge from the hospital

    Measured: One week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionMay 2016 (estimated)
  4. Study completionMay 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01276925
Sponsor's protocol ID
BBH-Z-THAMBUS
Acronym
THAMBUS
Status last verified
Oct 2015
First submitted
13 Jan 2011
Last updated
23 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine, Ultrasound and Peripheral nerve blockade in people with Pain, Postoperative, run by Bispebjerg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Birgitte M Krogh, MD (+45 50507405, sommanbehager@yahoo.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (time frame: At intervals during the first 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in