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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Intrathecal morphine

Ultrasound guided supra-inguinal fascia iliaca block

About this trial

This is an interventional prevention trial for Total Hip Replacement focused on measuring Total hip replacement, Ultrasound guided supra-inguinal fascia iliaca block, Intrathecal morphine, postoperative pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Siriraj hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Intrathecal morphine

Ultrasound guided supra-inguinal fascia iliaca block

Arm Description

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

0.25% bupivacaine 40 ml

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain score

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

Amount of rescue analgesic drugs

Amount of PCA fentanyl

Full Information

NCT ID

NCT04104204

First Posted

September 24, 2019

Last Updated

February 25, 2020

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT04104204

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 3, 2019 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intrathecal morphine

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Ultrasound guided supra-inguinal fascia iliaca block

Arm Type

Experimental

Arm Description

0.25% bupivacaine 40 ml

Intervention Type

Drug

Intervention Name(s)

Intrathecal morphine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ultrasound guided supra-inguinal fascia iliaca block

Intervention Description

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 Measure Information:

Title

Time to first analgesic request (PCA fentanyl)

Description

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 Outcome Measure Information:

Title

Pain score

Description

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

Time Frame

48 hours

Title

Amount of rescue analgesic drugs

Description

Amount of PCA fentanyl

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pawinee Pangthipampai, M.D.

Phone

+6686 400 1721

pawinee141@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pawinee Pangthipampai, M.D.

Organizational Affiliation

Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj hospital

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pawinee Pangthipampai, M.D.

Phone

66864001721

pawinee141@gmail.com

First Name & Middle Initial & Last Name & Degree

Pawinee Pangthipampai, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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