Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial (LPB Hip Scope)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Hospital for Special Surgery, New York.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Hospital for Special Surgery, New York
Collaborator:
New York Presbyterian Hospital
Information provided by:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01286805
First received: January 28, 2011
Last updated: May 31, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Pain |
Procedure: Lumbar Plexus Blockade Procedure: Control |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Hospital for Special Surgery, New York:
Primary Outcome Measures:
- The primary outcome is decrease NRS pain in the post-anesthesia care unit [ Time Frame: First 24 hours after surgery. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Readiness to discharge [ Time Frame: Time in the post anesthesia care unit (up to 4 hours) ] [ Designated as safety issue: No ]
- Narcotic pain medication needed [ Time Frame: First 24 hours after surgery. ] [ Designated as safety issue: No ]
- Incidence of nausea/vomiting [ Time Frame: First 24 hours after surgery ] [ Designated as safety issue: No ]
- Requirement of anti-emetic rescue [ Time Frame: First 24 hours after surgery ] [ Designated as safety issue: No ]
- Sensation to pinprick [ Time Frame: Time spend in the post-anesthesia care unit (up to 4 hours) ] [ Designated as safety issue: No ]
- Quadriceps strength [ Time Frame: 6-12 weeks postoperatively ] [ Designated as safety issue: No ]
- Patient satisfaction and quality of life [ Time Frame: Postoperative day 1 and 6 months after surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 82 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Procedure: Lumbar Plexus Blockade
The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine
Other Name: Marcaine
|
|
Placebo Comparator: Control Group
The control group will receive only a combined spinal-epidural.
|
Procedure: Control
The control group will receive only a combined spinal-epidural.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286805
Locations
| United States, New York | |
| Hospital for Special Surgery | |
| New York, New York, United States, 10021 | |
| New York Presbyterian Hospital | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Hospital for Special Surgery, New York
New York Presbyterian Hospital
Investigators
| Principal Investigator: | Jacques T YaDeau, M.D., Ph.D. | Hospital for Special Surgery, New York |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jacques YaDeau, MD PhD/Assistant Attending Anesthesiologist, Hospital for Special Surgery, New York |
| ClinicalTrials.gov Identifier: | NCT01286805 History of Changes |
| Other Study ID Numbers: | 10038 |
| Study First Received: | January 28, 2011 |
| Last Updated: | May 31, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013