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Status unknownNCT04104204Updated Feb 27, 2020

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

An interventional study of Intrathecal morphine and Ultrasound guided supra-inguinal fascia iliaca block in Total Hip Replacement, Ultrasound Guided Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-27.

Sponsored by Mahidol University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Total hip replacement
  • Ultrasound guided supra-inguinal fascia iliaca block
  • Intrathecal morphine
  • postoperative pain
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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 98 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
98 participants (estimated)

Study arms

  • Sham comparator
    Intrathecal morphine

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

    Drug: Intrathecal morphine

  • Experimental
    Ultrasound guided supra-inguinal fascia iliaca block

    0.25% bupivacaine 40 ml

    Drug: Ultrasound guided supra-inguinal fascia iliaca block

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

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What researchers measure

Primary outcomes

  1. Time to first analgesic request (PCA fentanyl)

    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

    Time frame: 48 hours

Secondary outcomes

  1. Pain score

    Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative

    Time frame: 48 hours

  2. Amount of rescue analgesic drugs

    Amount of PCA fentanyl

    Time frame: 48 hours

07

Study locations

1 of 1 sites recruiting
  • Siriraj hospital
    Bangkok, 10700, Thailand
    • Pawinee Pangthipampai, M.D. · Contact · pawinee141@gmail.com · 66864001721
    • Pawinee Pangthipampai, M.D. · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04104204
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Sep 26, 2019
Start date
Dec 3, 2019
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Feb 27, 2020

Study contacts

Pawinee Pangthipampai, M.D.
Contact
pawinee141@gmail.com
+6686 400 1721
Pawinee Pangthipampai, M.D.
principal investigator · Siriraj Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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