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.
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
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- 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.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, DK-2400
Kenneth Jensen, MD, +45 40259668, usg.pnb@gmail.com
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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.
- Conditions
- Pain, Postoperative
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. 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.
Pain
Verbal Rating Scale score (0-10) at rest.
Measured: At intervals during the first 48 hours after surgery
Secondary outcomes (9)
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
Opioid consumption
Measured: In intervals during the first 48 hours after surgery
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
Sedation
Assessed by the Pasero Opioid-induced Sedation Scale (POSS).
Measured: At intervals during the first 48 hours after surgery
Nausea
Assesed by
- a verbal scale (none, light, moderate, marked)
- the consumption of antiemetics
Measured: At intervals during the first 48 hours after surgery
Vomiting
Number of vomitings, estimated to have exceeded a volume of 10 ml.
Measured: In intervals during the first 48 hours after surgery
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
Mobilization
The time at which the patient walks for the first time after surgery.
Measured: The first 48 hours after surgery
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.
- First posted14 Jan 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Jensen, Bispebjerg Hospital
- Investigators
- Birgitte M Krogh, MD, Principal investigator, Bispebjerg HospitalKenneth Jensen, MD, Study director, Bispebjerg Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01276925
- Acronym / sponsor ID
- THAMBUS / BBH-Z-THAMBUS
- Conditions
- Pain, Postoperative
- Keywords
- Hip arthroplasty, Peripheral nervous blockade, Postoperative, Pain, Ropivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 14 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B3: Blockade of three nerves | Active comparator | Drug: Ropivacaine, Device: Ultrasound, Procedure: Peripheral nerve blockade, Procedure: Total hip arthroplasty, Drug: BupivacainePeripheral nerve blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with ropivacaine. |
| B2: Blockade of 2 nerves | Active comparator | Drug: Ropivacaine, Device: Ultrasound, Procedure: Peripheral nerve blockade, Drug: Saline, Procedure: Total hip arthroplasty, Drug: BupivacainePeripheral 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. |
| K: Control group | Sham comparator | Device: Ultrasound, Procedure: Peripheral nerve blockade, Drug: Saline, Procedure: Total hip arthroplasty, Drug: BupivacaineSham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: Naropin7,5 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. | Drug | B3: Blockade of three nerves |
| RopivacaineAlso: Naropin7,5 mg/ml. 10 ml for the anterior division of the obturator nerve, 5 ml for the lateral femoral cutaneous nerve. | Drug | B2: Blockade of 2 nerves |
| UltrasoundAll nerve blockades will be performed with ultrasound guidance. | Device | B2: Blockade of 2 nerves, B3: Blockade of three nerves, K: Control group |
| Peripheral nerve blockadeAll patients will receive injections around the three nerves before surgery. | Procedure or surgery | B2: Blockade of 2 nerves, B3: Blockade of three nerves, K: Control group |
| SalineIsotonic. 10 ml for the femoral nerve. | Drug | B2: Blockade of 2 nerves, K: Control group |
| Total hip arthroplastyAll patients undergoes total hip arthroplasty. | Procedure or surgery | B2: Blockade of 2 nerves, B3: Blockade of three nerves, K: Control group |
| BupivacaineAlso: Marcain spinal5 mg/ml. 3 ml for spinal anaesthesia. | Drug | B2: Blockade of 2 nerves, B3: Blockade of three nerves, K: Control group |
Primary outcome
Pain
Time frame: At intervals during the first 48 hours after surgery
Verbal Rating Scale score (0-10) at rest.
9 secondary outcomes
Pain
Time frame: At intervals during the first 48 hours after surgery
Opioid consumption
Time frame: In intervals during the first 48 hours after surgery
Bowel movement
Time frame: Within the first 48 hours after surgery
Sedation
Time frame: At intervals during the first 48 hours after surgery
Nausea
Time frame: At intervals during the first 48 hours after surgery
Vomiting
Time frame: In intervals during the first 48 hours after surgery
Mental and physical condition
Time frame: Before and at intervals during the first 48 hours after surgery
Mobilization
Time frame: The first 48 hours after surgery
Length of stay
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgitte M Krogh, MD principal investigator
Bispebjerg Hospital
Kenneth Jensen, MD study director
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
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.