Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04104204
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Total Hip Replacement Ultrasound Guided Supra-inguinal Fascia Iliaca Block Intrathecal Morphine Postoperative Pain Drug: Intrathecal morphine Drug: Ultrasound guided supra-inguinal fascia iliaca block Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guide Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine: A Randomized Controlled Trial
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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

Experimental: Ultrasound guided supra-inguinal fascia iliaca block
0.25% bupivacaine 40 ml
Drug: Ultrasound 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pain score [ Time Frame: 48 hours ]
    Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative

  2. Amount of rescue analgesic drugs [ Time Frame: 48 hours ]
    Amount of PCA fentanyl



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104204


Contacts
Layout table for location contacts
Contact: Pawinee Pangthipampai, M.D. +6686 400 1721 pawinee141@gmail.com

Locations
Layout table for location information
Thailand
Siriraj hospital Recruiting
Bangkok, Thailand, 10700
Contact: Pawinee Pangthipampai, M.D.    66864001721    pawinee141@gmail.com   
Principal Investigator: Pawinee Pangthipampai, M.D.         
Sponsors and Collaborators
Mahidol University
Investigators
Layout table for investigator information
Principal Investigator: Pawinee Pangthipampai, M.D. Siriraj Hospital

Layout table for additonal information
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04104204    
Other Study ID Numbers: Si 404/2019
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Total hip replacement
Ultrasound guided supra-inguinal fascia iliaca block
Intrathecal morphine
postoperative pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics