- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07316166
Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine
Comparison of Suprainguinal Fascia Iliac Block With and Without Dexmedetomidine as an Adjunct to Ropivacaine for Postoperative Analgesia Following Hip Surgery: a Randomized, Double-blinded Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Vendhan Ramanujam, M.D.
- Phone Number: 401-444-5172
- Email: vramanujam@brownhealth.org
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Recruiting
- The Miriam Hospital
-
Contact:
- Renee Dupre
- Phone Number: 401-793-4575
- Email: rdupre@brownhealth.org
-
Contact:
- Mark Kendall, M.D.
- Phone Number: 401-444-4722
- Email: mark.kendall@brownhealth.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients undergoing elective total hip arthroplasty
- 18-80 years old
- ASA 1-3 classifications
Exclusion Criteria:
- ASA classification of 4 or greater
- Infection at the site of nerve blockade
- Coagulopathy
- Known allergy to study medications
- Chronic opioid consumption (>3 months)
- Currently using lidocaine patches
- Pre-existing neuropathy
- A history of CVA
- High grade atrioventricular block (cardiac conduction system impairment)
- Organ dysfunction (cardiac failure, respiratory failure, end stage renal disease, hepatic dysfunction, hypoalbuminemia)
- Morbid obesity (≥40 kg/m2)
- Prior surgery in supra and/or infrainguinal region
- Non-English-speaking participants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ropivacaine
30 ml of 0.25% ropivacaine; No dexmedetomidine
|
In the experimental arm, ropivacaine (30 mL of 0.25%) is administered with dexmedetomidine. In the active comparator arm, ropivacaine (30 mL of 0.25%) is administered alone without any dexmedetomidine medication. |
|
Experimental: Ropivacaine plus Dexmedetomidine
30 ml of 0.25% ropivacaine; 1 mcg/kg of dexmedetomidine
|
In the experimental arm, ropivacaine (30 mL of 0.25%) is administered with dexmedetomidine. In the active comparator arm, ropivacaine (30 mL of 0.25%) is administered alone without any dexmedetomidine medication.
Participants in the experimental arm receive a preoperative suprainguinal fascia iliaca block consisting of 30 mL of 0.25% ropivacaine combined with perineural dexmedetomidine at a dose of 1 mcg/kg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time of administration of first analgesic after the surgery
Time Frame: Time to first analgesic request, defined as the interval (in minutes) from block administration to the first request for rescue analgesia, assessed for up to 24 hours.
|
Time to first analgesic request, defined as the interval (in minutes) from block administration to the first request for rescue analgesia, assessed for up to 24 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Recovery
Time Frame: 24 hours
|
The QoR-15 questionnaire has 15 questions that assess patient-reported quality of a patient's postoperative recovery using a 11-point numerical rating scale that leads to a minimum score of 0 (poor recovery) and a maximum score of 150 (excellent recovery).
|
24 hours
|
|
Total opioid consumption (converted to morphine milligram equivalents)
Time Frame: From the start of surgery through 48 hours postoperatively
|
Intraoperative period; PACU; and at 6, 12, 24, and 48 hours following surgery.
|
From the start of surgery through 48 hours postoperatively
|
|
Pain Scores
Time Frame: Up to two hours [post anesthesia recovery unit], 6 hours, 12 hours, 24 hours and 48 hours after surgery
|
Patients will be asked to rate their pain score on a 11-point scale (0 = no pain to 10 = excruciating pain).
|
Up to two hours [post anesthesia recovery unit], 6 hours, 12 hours, 24 hours and 48 hours after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
- Fernandez Martin MT, Alvarez Lopez S, Aldecoa Alvarez-Santullano C. Role of adjuvants in regional anesthesia: A systematic review. Rev Esp Anestesiol Reanim (Engl Ed). 2023 Feb;70(2):97-107. doi: 10.1016/j.redare.2021.06.006. Epub 2023 Feb 20.
- Chen A, Duan W, Hao R, Wang C, Xu X. Ultrasound-guided dexmedetomidine combination with modified high fascia iliaca compartment block for arthroscopic knee surgery: what is the optimal dose of dexmedetomidine? BMC Anesthesiol. 2023 Dec 6;23(1):400. doi: 10.1186/s12871-023-02361-0. Erratum In: BMC Anesthesiol. 2023 Dec 22;23(1):421. doi: 10.1186/s12871-023-02391-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2264738
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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