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The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guided Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine

M

Mahidol University

Status

Unknown

Conditions

Postoperative Pain
Intrathecal Morphine
Total Hip Replacement
Ultrasound Guided Supra-inguinal Fascia Iliaca Block

Treatments

Drug: Intrathecal morphine
Drug: Ultrasound guided supra-inguinal fascia iliaca block

Study type

Interventional

Funder types

Other

Identifiers

NCT04104204
Si 404/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

98 participants in 2 patient groups

Intrathecal morphine
Sham Comparator group
Description:
Intrathecal morphine 0.1 mg, A sham subcutaneous injection of 0.5 ml normal saline at inguinal area
Treatment:
Drug: Intrathecal morphine
Ultrasound guided supra-inguinal fascia iliaca block
Experimental group
Description:
0.25% bupivacaine 40 ml
Treatment:
Drug: Ultrasound guided supra-inguinal fascia iliaca block

Trial contacts and locations

1

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Central trial contact

Pawinee Pangthipampai, M.D.

Data sourced from clinicaltrials.gov

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