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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04104204
• Other study ID #: Si 404/2019
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: Mahidol University
• Contact: Pawinee Pangthipampai, M.D.
• Phone: +6686 400 1721
• Email: pawinee141[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours
Secondary	Pain score	Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative	48 hours
Secondary	Amount of rescue analgesic drugs	Amount of PCA fentanyl	48 hours