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Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine

ConditionPostoperative Pain Management
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRhode Island Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing elective total hip arthroplasty

18-80 years old

ASA 1-3 classifications

Disqualifiers

ASA classification of 4 or greater

Infection at the site of nerve blockade

Coagulopathy

Known allergy to study medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    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.

  • Ropivacaine

    Drug

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: RopivacaineActive comparator 1 intervention
Group B: Ropivacaine plus DexmedetomidineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

Total opioid consumption (converted to morphine milligram equivalents)

Intraoperative period; PACU; and at 6, 12, 24, and 48 hours following surgery.

Time frame
From the start of surgery through 48 hours postoperatively
2

Quality of Recovery

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
24 hours
3

Pain Scores

Patients will be asked to rate their pain score on a 11-point scale (0 = no pain to 10 = excruciating pain).

Time frame
Up to two hours [post anesthesia recovery unit], 6 hours, 12 hours, 24 hours and 48 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rhode Island Hospital

Lead sponsor

Source ClinicalTrials.gov
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