- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01286805
Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial (LPB Hip Scope)
May 1, 2013 updated by: Hospital for Special Surgery, New York
The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain.
In addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction.
It is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10021
- Hospital for Special Surgery
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New York, New York, United States, 10065
- New York Presbyterian Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) Class 1-3
- Patients aged 18 to 65 years
- Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat
- Planned use of neuraxial anesthesia
- Body Mass Index less than 35
- Ability to follow study protocol
Exclusion Criteria:
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
- Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
- Infection at the injection site(s)
- Allergy to any of the study medications
- Contraindication to a short course of NSAIDs (renal failure, intolerance)
- ASA Class 4-5
- Patient refusal
- Patients younger than 18 years old and older than 65
- Patients with any known indwelling hardware of the lumbar spine.
- Patients with a peripheral neuropathy of the surgical extremity
- Non-English speaking patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lumbar Plexus Blockade + CSE
The study group will receive a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
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The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine
Other Names:
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Placebo Comparator: Control Group
The control group will receive only a combined spinal-epidural.
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The control group will receive only a combined spinal-epidural.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge
Time Frame: Day of surgery prior to discharge
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The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.
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Day of surgery prior to discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readiness to Discharge From Post-Anesthesia Care Unit (PACU)
Time Frame: Day of surgery prior to discharge
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Time to readiness for discharge from the PACU.
Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.
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Day of surgery prior to discharge
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Narcotic Pain Medication Needed
Time Frame: Day of surgery prior to discharge
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Day of surgery prior to discharge
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Incidence of Nausea
Time Frame: Day of surgery prior to discharge
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The number of participants with nausea.
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Day of surgery prior to discharge
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Incidence of Vomiting
Time Frame: Day of surgery prior to discharge
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The number of participants who vomited.
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Day of surgery prior to discharge
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Requirement of Antiemetic Rescue
Time Frame: Day of surgery prior to discharge
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The number of participants who needed medication to treat their nausea and vomiting.
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Day of surgery prior to discharge
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Patient Satisfaction
Time Frame: First 24 hours after surgery
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Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)
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First 24 hours after surgery
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Quality of Recovery (QoR-40) Physical Comfort Dimension
Time Frame: First 24 hours after surgery
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Assessment of Physical Comfort (minimum score = 12, maximum score = 60).
Higher values represent a better outcome
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First 24 hours after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
January 28, 2011
First Submitted That Met QC Criteria
January 28, 2011
First Posted (Estimate)
January 31, 2011
Study Record Updates
Last Update Posted (Estimate)
June 5, 2013
Last Update Submitted That Met QC Criteria
May 1, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10038 (DAIDS ES)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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