The Miriam Hospital
Providence, Rhode Island, 02906, United States
Location status: Recruiting
Location contact
Mark Kendall, M.D.
CONTACT
Renee Dupre
CONTACT
NCT Number: NCT07316166
The investigators are evaluating postoperative outcomes in patients undergoing hip replacement surgery performed with either spinal or general anesthesia, who also receive a suprainguinal fascia iliaca block using either perineural ropivacaine alone or ropivacaine combined with dexmedetomidine.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 4
Providence, Rhode Island, 02906, United States
Location status: Recruiting
Mark Kendall, M.D.
CONTACT
Renee Dupre
CONTACT
Patients undergoing hip replacement surgery often receive a single-shot suprainguinal fascia iliaca block as a part of the primary anesthetic and multimodal postoperative analgesic strategy. However, the analgesic effect of a single-shot block typically diminishes after several hours and may be inconsistent beyond 24 hours. Adding dexmedetomidine, an alpha-2 agonist, to the local anesthetic has been shown to prolong block duration and reduce postoperative opioid requirements. Investigating its use in suprainguinal fascia iliaca blocks for total hip arthroplasty may clarify its clinical effectiveness. The investigators hypothesize that patients receiving ropivacaine with dexmedetomidine will have a significantly longer time to first analgesic request compared to those receiving ropivacaine alone.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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 frame: From the start of surgery through 48 hours postoperatively
Intraoperative period; PACU; and at 6, 12, 24, and 48 hours following surgery.
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).
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).
Contact information is provided by the study sponsor or research team.
Rhode Island Hospital
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07694141
Neurologic Manifestations, Pain
Las Palmas de Gran Canaria, Las Palmas, Spain
View Trial DetailsNCT07145619
Neurologic Manifestations, Obstetric Anesthesia
Samsun, Turkey (Türkiye)
View Trial DetailsNCT07524673
Neurologic Manifestations, Pain
Sivas, Merkez, Turkey (Türkiye)
View Trial DetailsNCT07248072
Arthritis, Joint Diseases
Erzurum, Turkey (Türkiye)
View Trial Details