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

NCT04104204 | Unknown

• 1 other identifier: Si 404/2019
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

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

  48 hours

Secondary Outcomes (2)

• Pain score

  48 hours

• Amount of rescue analgesic drugs

  48 hours

Study Arms (2)

Intrathecal morphine

SHAM COMPARATOR

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

Drug: Intrathecal morphine

Ultrasound guided supra-inguinal fascia iliaca block

EXPERIMENTAL

0.25% bupivacaine 40 ml

Drug: Ultrasound guided supra-inguinal fascia iliaca block

Interventions

Intrathecal morphine DRUG

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

Intrathecal morphine

Ultrasound guided supra-inguinal fascia iliaca block DRUG

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

Ultrasound guided supra-inguinal fascia iliaca block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective surgery of primary total hip replacement, body weight ≥40kg and BMI ≤35 kg/m2, competence to consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Pawinee Pangthipampai, M.D.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pawinee Pangthipampai, M.D.

CONTACT

+6686 400 1721; pawinee141@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: December 3, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)