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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04104204
Enrollment
98
Registered
2019-09-26
Start date
2019-12-03
Completion date
2021-12-31
Last updated
2020-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Total hip replacement, Ultrasound guided supra-inguinal fascia iliaca block, Intrathecal morphine, postoperative pain

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.

Interventions

DRUGIntrathecal morphine

0.5% Iso/Hyperbaric bupivacaine 2-3 ml add morphine 0.1 mg for spinal anesthesia

DRUGUltrasound guided supra-inguinal fascia iliaca block

Ultrasound guided supra-inguinal fascia iliaca block with 0.25% bupivacaine 40 ml and 0.5% Iso/Hyperbaric bupivacaine 2-3 ml without spinal morphine for spinal anesthesia

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time to first analgesic request (PCA fentanyl)48 hoursWhether 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

MeasureTime frameDescription
Pain score48 hoursPain score at rest and on movement rating by numerical rating scale in 48-hr postoperative
Amount of rescue analgesic drugs48 hoursAmount of PCA fentanyl

Countries

Thailand

Contacts

Primary ContactPawinee Pangthipampai, M.D.
pawinee141@gmail.com+6686 400 1721

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026