Postoperative Pain Control After Hip Hemiarthroplasty: Intrathecal Morphine vs Periarticular Infiltration of Bupivacaine

NCT ID: NCT01219062

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-04-30

Brief Summary

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Falls are a common problem in elderly people which they have to receive the operation. Hemiarthroplasty is one of the common orthopedics operations. The prompt operation and good pain control will provide the good recovery and outcome. The investigators compare the efficacy of postoperative pain control between Intrathecal morphine 0.1 milligrams (mg.) with the local infiltration of 0.25% Bupivacaine for 20 milliliters (ml.) in patients received hip hemiarthroplasty under spinal anesthesia.

Detailed Description

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Study process All the patients who assigned the hip hemiarthroplasty without any exclusion criteria will be enrolled in the study and be divided into 3 groups randomly

1. control group : the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)
2. Morphine group : the patients will be received 0.1 mg. of Morphine added in Isobaric Bupivacaine for spinal anesthesia and postoperative pain control by IV PCA
3. Local group : the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA

Data collection

1. Demographic data : age, sex, Body Weight, Body Mass Index (BMI), ...
2. Pain score every 3 hours postoperatively in the first 6 hours and at the 12th hours by visual analogue scoring system
3. Patient global assessment and patient satisfactory visual analogue scoring system at 24th and 48th hour
4. the amount of morphine during 24 and 48 hours postoperative and the time of first dose they received

Conditions

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Femoral Neck Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

The patient will be performed spinal anesthesia alone, with postoperative PCA

Group Type PLACEBO_COMPARATOR

control

Intervention Type OTHER

the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)

Morphine

The patient will received intrathecal Morphine for 0.1 mg. in Isobaric bupivacaine in spinal anesthesia and postoperative PCA

Group Type ACTIVE_COMPARATOR

morphine

Intervention Type DRUG

periarticular infiltration with 0.25% Bupivacaine for 20 ml.

bupivacaine

the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA

Interventions

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morphine

periarticular infiltration with 0.25% Bupivacaine for 20 ml.

Intervention Type DRUG

control

the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)

Intervention Type OTHER

Bupivacaine

the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age between 18-90 years
* Co-operative, able to use PCA
* ASA classification 1-3
* no contraindication for Spinal Anesthesia
* patient acceptance for spinal anesthesia
* body weight \> 30 kg.
* BMI between 20-35
* no history of drug allergy, e.g. Local Anesthetics, Paracetamol, etc.

Exclusion Criteria

* age \> 90 years
* previous Hemiarthroplasty (the same site)
* pathological fracture such as severe infection, bone cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Aphichat Suphathamwit,

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thitima Chinachoti, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Faculty of Medicine Siriraj Hospital

Bangkok, , Thailand

Site Status

Thitima Chinachot

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Si391/2010

Identifier Type: -

Identifier Source: org_study_id

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