Nerve BlockNCT03244631
Pain Control in Hip Arthroscopy: Comparing Lumbar Plexus Versus Peri-capsular Injection
A study testing Lumbar Plexus BLock and Pericapsular injection in people with Nerve Block and Hip Arthroscopy, run by Washington Orthopaedics and Sports Medicine at 1 site in United States.
Trial summary
Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during hip arthroscopy Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Block, Hip Arthroscopy
- What is being tested?
- Lumbar Plexus BLock and Pericapsular injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 1 Feb 2020
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient scheduled to undergo hip arthroscopy with Dr. Wolff
- Patient age between 25 and 60 years of age.
Who cannot join
- Patient has known allergy to ropivicaine or morphine.
- Patient unable to speak/read English (No translators available in clinic site).
- Pregnant female.
- Patient has a pre-operative narcotic use for hip pain
- Patient has pre-existing chronic pain disorder (i.e. fibromyalgia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Orthopedics and Sports Medicine
Chevy Chase, Maryland, 20815
About this study
Official title: Prospective, Single Blind Randomzied Controlled Trial Comparing Lumbar Plexus Peripheral Nerve Block Versus Peri-capsular Injection for Hip Arthroscopy
Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during hip arthroscopy
Read the detailed description
The purpose of this study is to compare two different methods of pain control during and after hip arthroscopy surgery. It is not clear which of many different pain control methods are ideal to reduce pain for patients; consequently, the investigators are performing this study to compare the two main choices for pain control commonly used in order to identify if either is superior to the other.
- Conditions
- Nerve Block, Hip Arthroscopy
- Being tested
- Lumbar Plexus BLock, Pericapsular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Plexus BLockProcedure or surgery
Peripheral nerve block
Pericapsular injectionProcedure or surgery
Injection around the area undergoing surgery
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Plexus Block | Active comparator | A lumbar plexus 'nerve block' is a procedure in which local anesthetic ("numbing medicine") is injected around a specific group of nerves to provide pain relief directly to the nerves supplying the area of the body undergoing surgery. Receives: Procedure: Lumbar Plexus BLock |
| Pericapsular Injection | Active comparator | The pericapsular injection is a procedure in which local anesthetic ("numbing medicine") is injected around the hip joint to provide direct pain relief to the area undergoing surgery. Receives: Procedure: Pericapsular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Compare post-operative pain scores in the immediate post-operative period as defined by visual-analog pain scale at the time point of one hour spent in the post-anesthesia care unit (PACU).
Measured: At the one hour point in the PACU
Secondary outcomes (2)
Morphine equivalents
Compare the total morphine equivalents of opioids provided in the PACU within the first two hours of time spent in the PACU
Measured: At the two hour point in the PACU
Time spent in PACU
Compare the overall time spent in the PACU as defined by time to arrival to time to discharge vitals.
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start26 Sep 2017
- Primary completion1 Sep 2018
- Study completion1 Feb 2020
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 Nerve BlockStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington Orthopaedics and Sports Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew B. Wolff, MD, Washington Orthopaedics and Sports Medicine
- Investigators
- Andrew Wolff, MD, Principal investigator, Washington Orthopaedics and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244631
- Sponsor's protocol ID
- 20171307
- Status last verified
- Feb 2020
- First submitted
- 28 Jul 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scanaliato JP, Christensen D, Polmear MM, Salfiti C, Gaspar PS, Wolff AB. Prospective Single-Blinded Randomized Controlled Trial Comparing Pericapsular Injection Versus Lumbar Plexus Peripheral Nerve Block for Hip Arthroscopy. Am J Sports Med. 2020 Sep;48(11):2740-2746. doi: 10.1177/0363546520943580. Epub 2020 Aug 6.
PubMed 32757999
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Blind Randomzied Controlled Trial Comparing Lumbar Plexus Peripheral Nerve Block Versus Peri-capsular Injection for Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT03244631
- Acronym / sponsor ID
- 20171307
- Conditions
- Nerve Block, Hip Arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Washington Orthopaedics and Sports MedicineUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 9 Aug 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.
Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during hip arthroscopy
Detailed description
The purpose of this study is to compare two different methods of pain control during and after hip arthroscopy surgery. It is not clear which of many different pain control methods are ideal to reduce pain for patients; consequently, the investigators are performing this study to compare the two main choices for pain control commonly used in order to identify if either is superior to the other.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized
| Arm | Type | Receives |
|---|---|---|
| Lumbar Plexus Block | Active comparator | Procedure: Lumbar Plexus BLockA lumbar plexus 'nerve block' is a procedure in which local anesthetic ("numbing medicine") is injected around a specific group of nerves to provide pain relief directly to the nerves supplying the area of the body undergoing surgery. |
| Pericapsular Injection | Active comparator | Procedure: Pericapsular injectionThe pericapsular injection is a procedure in which local anesthetic ("numbing medicine") is injected around the hip joint to provide direct pain relief to the area undergoing surgery. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient scheduled to undergo hip arthroscopy with Dr. Wolff
- Patient age between 25 and 60 years of age.
Key exclusion criteria (5 listed)
- Patient has known allergy to ropivicaine or morphine.
- Patient unable to speak/read English (No translators available in clinic site).
- Pregnant female.
- Patient has a pre-operative narcotic use for hip pain
- Patient has pre-existing chronic pain disorder (i.e. fibromyalgia)
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 |
|---|---|---|
| Lumbar Plexus BLockPeripheral nerve block | Procedure or surgery | Lumbar Plexus Block |
| Pericapsular injectionInjection around the area undergoing surgery | Procedure or surgery | Pericapsular Injection |
Primary outcome
Pain score
Time frame: At the one hour point in the PACU
Compare post-operative pain scores in the immediate post-operative period as defined by visual-analog pain scale at the time point of one hour spent in the post-anesthesia care unit (PACU).
2 secondary outcomes
Morphine equivalents
Time frame: At the two hour point in the PACU
Time spent in PACU
Time frame: Immediately after surgery
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 12 Feb 2020.
- Derived from this study: PubMed 32757999Scanaliato JP, Christensen D, Polmear MM, Salfiti C, Gaspar PS, Wolff AB. Prospective Single-Blinded Randomized Controlled Trial Comparing Pericapsular Injection Versus Lumbar Plexus Peripheral Nerve Block for Hip Arthroscopy. Am J Sports Med. 2020 Sep;48(11):2740-2746. doi: 10.1177/0363546520943580. Epub 2020 Aug 6.
- Individual participant dataSharing planned: No
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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.
Andrew Wolff, MD principal investigator
Washington Orthopaedics and Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Plexus BLock and Pericapsular injection in people with Nerve Block and Hip Arthroscopy, run by Washington Orthopaedics and Sports Medicine at 1 site in United States.
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 2 inclusion and 5 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 12 Feb 2020. 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 United States. 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. 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?
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?
Pain score (time frame: At the one hour point in the PACU). 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 NCT03244631, 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 12 Feb 2020; AzTrials last refreshed its copy on 30 Oct 2026.