Hip DiseaseNCT04917510
Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy
A study testing Erector spinae block and Local block in people with Hip Disease and Postoperative Pain, run by Carilion Clinic at 1 site in United States.
Trial summary
The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial. Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Hip Disease, Postoperative Pain
- What is being tested?
- Erector spinae block and Local block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2021to Aug 2023
- 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 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients undergoing hip arthroscopy for femoroacetabular impingement
- Ages 13-50
- Individuals who have the capacity to provide consent or assent for themselves
Who cannot join
- Hip arthroscopy for any other reason (not undergoing labral repair, acetabuloplasty, and femoral osteochondroplasty)
- Revision surgery
- Known narcotic use in the 6 months prior to surgery
- Workman's compensation patient
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Orthopedics and Neurosciences
Roanoke, Virginia, 24014
About this study
Official title: Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy: A Prospective Analysis
The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial.
Read the detailed description
The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial. The control group will not receive a preoperative block prior to surgery, but will receive local anesthetic at the surgical site at the conclusion of the surgery. The study group will receive a preoperative block and local anesthetic. The primary outcomes will be pain levels and opioid consumption in the post-operative care unit. The secondary outcomes will be pain levels and opioid consumption post-operatively, and functional outcome measures.
- Conditions
- Hip Disease, Postoperative Pain
- Being tested
- Erector spinae block, Local block
- Keywords
- Hip, Pain, Arthroscopy
- 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.
Erector spinae blockProcedure or surgery
See experimental arm group description
Local blockProcedure or surgery
See control and study arm group descriptions for the local block
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Will not receive erector spinae block. Will be administered 30 mL of 0.5% Marcaine w/ epinephrine as a local block at the surgical site at the conclusion of the procedure. Receives: Procedure: Local block |
| Study | Experimental | Will receive an erector spinae block prior to surgery using 30-45 mL of 0.25 bupivacaine w/ epinephrine and 5 mL of dexmedetomidine. Will be administered 30 mL of 0.5% marcaine w/ epinephrine as a local block at the surgical site at the conclusion of the procedure. Receives: Procedure: Erector spinae block; Procedure: Local block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Anesthesia Care Unit Opioids
Total morphine milligram equivalents of administered in the post-operative care unit
Measured: 6 hours post-operatively
Post Anesthesia Care Unit Pain
Visual analogue pain score at the time of discharge from the Post Anesthesia Care Unit in which 0 equals no pain and 10 equals extreme pain
Measured: 6 hours post-operatively
Secondary outcomes (5)
Hip disability and Osteoarthritis Outcome Score
Hip disability and Osteoarthritis Outcome score at post-op visits in which 0 equals no pain and 100 equals unbearable pain
Measured: 1 year post-operatively
Patient Reported Outcomes measurement Information System Score
Patient Reported Outcomes measurement Information System score at post-op visits in which 0 equals no pain and 10 equals extreme pain
Measured: 1 year post-operatively
Range Of Motion
Hip range of motion in degrees of motion, will be examined by the operative surgeon in the office measured by flexion 0-110 degrees with 0 being no range of motion and 110 being full range of motion, internal rotation -5-25 degrees with -5 being no range of motion and -25 being full range of motion, and external rotation 0-60 degrees with 0 being no range of motion and 60 being full range of motion.
Measured: 1 year post-operatively
Outpatient Opioids
Opioids consumed after discharge from hospital
Measured: 4 weeks post discharge
Outpatient Visual Analog Scale scores
Pain scores each day for the first 4 weeks after surgery on the Visual Analog Scale in which 0 equals no pain and 10 equals unbearable pain
Measured: 4 weeks post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study startJul 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DiseaseStudies 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
- Model description
- Patients will be randomized to either the study group or control group prior to undergoing surgery
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Coobs, MD, Principal investigator, Carilion Clinic Ortho Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917510
- Sponsor's protocol ID
- IRB-21-1223
- Status last verified
- Jun 2021
- First submitted
- 28 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy: A Prospective Analysis
- ClinicalTrials.gov ID
- NCT04917510
- Acronym / sponsor ID
- IRB-21-1223
- Conditions
- Hip Disease, Postoperative Pain
- Keywords
- Hip, Pain, Arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Jun 2021 (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 aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial.
Detailed description
The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial. The control group will not receive a preoperative block prior to surgery, but will receive local anesthetic at the surgical site at the conclusion of the surgery. The study group will receive a preoperative block and local anesthetic. The primary outcomes will be pain levels and opioid consumption in the post-operative care unit. The secondary outcomes will be pain levels and opioid consumption post-operatively, and functional outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to either the study group or control group prior to undergoing surgery
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Local blockWill not receive erector spinae block. Will be administered 30 mL of 0.5% Marcaine w/ epinephrine as a local block at the surgical site at the conclusion of the procedure. |
| Study | Experimental | Procedure: Erector spinae block, Procedure: Local blockWill receive an erector spinae block prior to surgery using 30-45 mL of 0.25 bupivacaine w/ epinephrine and 5 mL of dexmedetomidine. Will be administered 30 mL of 0.5% marcaine w/ epinephrine as a local block at the surgical site at the conclusion of the procedure. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All patients undergoing hip arthroscopy for femoroacetabular impingement
- Ages 13-50
- Individuals who have the capacity to provide consent or assent for themselves
Key exclusion criteria (5 listed)
- Hip arthroscopy for any other reason (not undergoing labral repair, acetabuloplasty, and femoral osteochondroplasty)
- Revision surgery
- Known narcotic use in the 6 months prior to surgery
- Workman's compensation patient
- Pregnancy
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 |
|---|---|---|
| Erector spinae blockSee experimental arm group description | Procedure or surgery | Study |
| Local blockSee control and study arm group descriptions for the local block | Procedure or surgery | Control, Study |
Primary outcome
Post Anesthesia Care Unit Opioids
Time frame: 6 hours post-operatively
Total morphine milligram equivalents of administered in the post-operative care unit
Post Anesthesia Care Unit Pain
Time frame: 6 hours post-operatively
Visual analogue pain score at the time of discharge from the Post Anesthesia Care Unit in which 0 equals no pain and 10 equals extreme pain
5 secondary outcomes
Hip disability and Osteoarthritis Outcome Score
Time frame: 1 year post-operatively
Patient Reported Outcomes measurement Information System Score
Time frame: 1 year post-operatively
Range Of Motion
Time frame: 1 year post-operatively
Outpatient Opioids
Time frame: 4 weeks post discharge
Outpatient Visual Analog Scale scores
Time frame: 4 weeks post discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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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.
Benjamin Coobs, MD principal investigator
Carilion Clinic Ortho Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae block and Local block in people with Hip Disease and Postoperative Pain, run by Carilion Clinic 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 3 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: status not confirmed, as of the sponsor's last update on 8 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Coobs, MD ((540) 521-3830, brcoobs@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Anesthesia Care Unit Opioids (time frame: 6 hours post-operatively). The study lists 2 primary outcomes in all. 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 8 Jun 2021.