Obturator Nerve BlockPhase 4NCT03064165
Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator Nerve Blockade
A Phase 4 study testing Bupivacaine-epinephrine, Obturator nerve block and Sodium Chloride 9mg/mL in people with Obturator Nerve Block and Total Hip Replacement, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obturator Nerve Block, Total Hip Replacement
- What is being tested?
- Bupivacaine-epinephrine, Obturator nerve block and Sodium Chloride 9mg/mL
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2017to 8 Jun 2018
- Phase
- Phase 4
- 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
- Patients for primary hip replacement in spinal anesthesia
- Age >= 18 years
- American Society of Anesthesiologists physical status classification score I-III
- Informed consent
Who cannot join
- Lacking the ability to corporate
- Lacking the ability to speak danish
- Planned discharge on the same day of surgery
- Neuropathy of the lower extremities
- Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID)
- Contraindications for dexamethasone
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- Chronic opioid demanding pain
- Pregnancy
- Allergy towards one or both investigatory medicinal products
- Active treatment with amiodarone
- Active treatment with verapamil
- Active treatment with corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator
The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.
- Conditions
- Obturator Nerve Block, Total Hip Replacement
- Being tested
- Bupivacaine-epinephrine, Sham block, Obturator nerve block, Sodium Chloride 9mg/mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-epinephrineDrug
Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.
Sham blockProcedure or surgery
Injection as for obturator nerve block, but with placebo
Obturator nerve blockProcedure or surgery
Postoperative obturator nerve block
Sodium Chloride 9mg/mLDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Obturator nerve block | Experimental | Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL. Receives: Drug: Bupivacaine-epinephrine; Procedure: Obturator nerve block |
| Sham block | Placebo comparator | Postoperative sham-block with normal saline. Receives: Procedure: Sham block; Drug: Sodium Chloride 9mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid dose 0-12 hour after total hip replacement
Cumulated dose of opioid 0-12 hour after total hip replacement
Measured: 0-12 hour after completion of total hip replacement
Secondary outcomes (15)
Cumulated dose of opioid 12-18 hours after total hip replacement.
Measured: 12-18 hours after completion of total hip replacement
Pain at rest at time of examination (numeric rating scale)
Measured: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
Pain at passive 90-degree hip flexion (numeric rating scale)
Measured: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
Worst pain during ambulation on the day of surgery
Measured: 5 hours after completion of total hip replacement
Time from completion of surgery to first dose of opioid
Measured: 24 hours after completion of total hip replacement
Intensity of nausea on time of examination (numeric rating scale)
Measured: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
Incidences of emesis 0-18 hours after total hip replacement.
Measured: 0-18 hours after completion of total hip replacement
Cumulated dose of ondansetron 0-18 hours after total hip replacement
Measured: 0-18 hours after completion of total hip replacement
Cumulated dose of droperidol 0-18 hours after total hip replacement
Measured: 0-18 hours after completion of total hip replacement
Length of stay on post anesthesia care unit after completion of total hip replacement
Measured: 24 hours after completion of total hip replacement
Length of stay on hospital after completion of total hip replacement
Measured: Up to 2 days
Ability to ambulate 5 hours after surgery
Ability to sit, stand, walk with tall rollator and walk with crutches
Measured: 5 hours after completion of total hip replacement
Motor control with operated leg
Physiotherapist evaluating motor control with operated leg during ambulation.
Measured: 5 hours after completion of total hip replacement
Self-reported sleep quality the first night after total hip replacement
Self-reported sleep quality on a 3-point-scale: 2 = Undisturbed sleep; 1 = Sleep disturbed by other reasons than pain; 0 = Sleep disturbed by pain.
Measured: 24 hours after completion of total hip replacement
Duration of spinal anesthesia
Time from end of operation until regain of normal sensibility on anterior femur.
Measured: 0-4 hours after completion of total hip replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start15 Aug 2017
- Primary completion8 Jun 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obturator Nerve BlockStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Elective Surgery Centre, Silkeborg Regional Hospital
- Responsible party
- Principal investigator, Niels Dalsgaard Nielsen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064165
- Sponsor's protocol ID
- HIP/FUSION#2
- Status last verified
- Sep 2018
- First submitted
- 13 Feb 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared through the Danish Data Archive.
Publications
Nielsen ND, Runge C, Clemmesen L, Borglum J, Mikkelsen LR, Larsen JR, Nielsen TD, Soballe K, Bendtsen TF. An Obturator Nerve Block does not Alleviate Postoperative Pain after Total Hip Arthroplasty: a Randomized Clinical Trial. Reg Anesth Pain Med. 2019 Jan 23:rapm-2018-100104. doi: 10.1136/rapm-2018-100104. Online ahead of print.
PubMed 30679337
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator
- ClinicalTrials.gov ID
- NCT03064165
- Acronym / sponsor ID
- HIP/FUSION#2
- Conditions
- Obturator Nerve Block, Total Hip Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Elective Surgery Centre, Silkeborg Regional Hospital
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 8 Jun 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 24 Feb 2017 (actual)
- 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.
The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obturator nerve block | Experimental | Drug: Bupivacaine-epinephrine, Procedure: Obturator nerve blockPostoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL. |
| Sham block | Placebo comparator | Procedure: Sham block, Drug: Sodium Chloride 9mg/mLPostoperative sham-block with normal 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)
- Patients for primary hip replacement in spinal anesthesia
- Age >= 18 years
- American Society of Anesthesiologists physical status classification score I-III
- Informed consent
Key exclusion criteria (12 listed)
- Lacking the ability to corporate
- Lacking the ability to speak danish
- Planned discharge on the same day of surgery
- Neuropathy of the lower extremities
- Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID)
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 |
|---|---|---|
| Bupivacaine-epinephrineNerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL. | Drug | Obturator nerve block |
| Sham blockInjection as for obturator nerve block, but with placebo | Procedure or surgery | Sham block |
| Obturator nerve blockPostoperative obturator nerve block | Procedure or surgery | Obturator nerve block |
| Sodium Chloride 9mg/mLPlacebo | Drug | Sham block |
Primary outcome
Opioid dose 0-12 hour after total hip replacement
Time frame: 0-12 hour after completion of total hip replacement
Cumulated dose of opioid 0-12 hour after total hip replacement
15 secondary outcomes
Cumulated dose of opioid 12-18 hours after total hip replacement.
Time frame: 12-18 hours after completion of total hip replacement
Pain at rest at time of examination (numeric rating scale)
Time frame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
Pain at passive 90-degree hip flexion (numeric rating scale)
Time frame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
Worst pain during ambulation on the day of surgery
Time frame: 5 hours after completion of total hip replacement
Time from completion of surgery to first dose of opioid
Time frame: 24 hours after completion of total hip replacement
Intensity of nausea on time of examination (numeric rating scale)
Time frame: 1, 2, 5, 7 and 24 hours after completion of total hip replacement
Incidences of emesis 0-18 hours after total hip replacement.
Time frame: 0-18 hours after completion of total hip replacement
Cumulated dose of ondansetron 0-18 hours after total hip replacement
Time frame: 0-18 hours after completion of total hip replacement
Cumulated dose of droperidol 0-18 hours after total hip replacement
Time frame: 0-18 hours after completion of total hip replacement
Length of stay on post anesthesia care unit after completion of total hip replacement
Time frame: 24 hours after completion of total hip replacement
Length of stay on hospital after completion of total hip replacement
Time frame: Up to 2 days
Ability to ambulate 5 hours after surgery
Time frame: 5 hours after completion of total hip replacement
Motor control with operated leg
Time frame: 5 hours after completion of total hip replacement
Self-reported sleep quality the first night after total hip replacement
Time frame: 24 hours after completion of total hip replacement
Duration of spinal anesthesia
Time frame: 0-4 hours after completion of total hip replacement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Derived from this study: PubMed 30679337Nielsen ND, Runge C, Clemmesen L, Borglum J, Mikkelsen LR, Larsen JR, Nielsen TD, Soballe K, Bendtsen TF. An Obturator Nerve Block does not Alleviate Postoperative Pain after Total Hip Arthroplasty: a Randomized Clinical Trial. Reg Anesth Pain Med. 2019 Jan 23:rapm-2018-100104. doi: 10.1136/rapm-2018-100104. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Data will be shared through the Danish Data Archive.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine-epinephrine, Obturator nerve block and Sodium Chloride 9mg/mL in people with Obturator Nerve Block and Total Hip Replacement, run by University of Aarhus 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 12 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: finished, as of the sponsor's last update on 10 Sep 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid dose 0-12 hour after total hip replacement (time frame: 0-12 hour after completion of total hip replacement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064165, which also lists 1 linked publication.
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 10 Sep 2018.