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Clinical Trials/NCT04104204
NCT04104204
Unknown
Not Applicable

The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guide Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine: A Randomized Controlled Trial

Mahidol University1 site in 1 country98 target enrollmentDecember 3, 2019

Overview

Phase
Not Applicable
Intervention
Intrathecal morphine
Conditions
Total Hip Replacement
Sponsor
Mahidol University
Enrollment
98
Locations
1
Primary Endpoint
Time to first analgesic request (PCA fentanyl)
Last Updated
6 years ago

Overview

Brief Summary

Total hip replacement is one of major orthopedic surgery which result in severe postoperative pain especially at first 24 hours. Ultrasound guided regional anesthesia has become a part of multimodal analgesia.Ultrasound guided supra-inguinal fascia iliaca block is a new technique which can consistently cover femoral and lateral femoral cutaneous nerve. And with large volume (40ml), it may cover obturator nerve. This technique already proved to be useful for acute pain control in hip fracture or postoperative control in dynamic hip screw or nail insertion operation. However, it has not been compared with intrathecal morphine for total hip replacement yet.

Detailed Description

By using combine ultrasound guided supra-inguinal fascia iliaca block with periarticular infiltration with mutimodal analgesic drugs will have longer duration time to first rescue analgesic drug compared with combine intrathecal morphine with periarticular infiltration with multimodal analgesic drugs.

Registry
clinicaltrials.gov
Start Date
December 3, 2019
End Date
December 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • elective surgery of primary total hip replacement, body weight ≥40kg and BMI ≤35 kg/m2, competence to consent

Exclusion Criteria

  • contraindication to regional anesthesia, allergy to study drugs, skin infection at supra-inguinal fascia iliaca injection point, neurological deficit affecting the lower extremities, inability to use patient-controlled analgesia, GFR \<50 mL/min

Arms & Interventions

Intrathecal morphine

Intrathecal morphine 0.1 mg, A sham subcutaneous injection of 0.5 ml normal saline at inguinal area

Intervention: Intrathecal morphine

Ultrasound guided supra-inguinal fascia iliaca block

0.25% bupivacaine 40 ml

Intervention: Ultrasound guided supra-inguinal fascia iliaca block

Outcomes

Primary Outcomes

Time to first analgesic request (PCA fentanyl)

Time Frame: 48 hours

Whether ultrasound guided supra-inguinal fascia iliaca block can increase pain free period of patients undergo total hip replacement under spinal block compare with intrathecal morphine or not

Secondary Outcomes

  • Pain score(48 hours)
  • Amount of rescue analgesic drugs(48 hours)

Study Sites (1)

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