Postoperative Pain Control After Hip Hemiarthroplasty: Intrathecal Morphine vs Periarticular Infiltration of Bupivacaine
Primary Purpose
Femoral Neck Fracture
Status
Terminated
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
morphine
control
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine Siriraj Hospital
- Thitima Chinachot
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
control
Morphine
bupivacaine
Arm Description
The patient will be performed spinal anesthesia alone, with postoperative PCA
The patient will received intrathecal Morphine for 0.1 mg. in Isobaric bupivacaine in spinal anesthesia and postoperative PCA
the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA
Outcomes
Primary Outcome Measures
The Amount of Morphine consumption after Hemiarthroplasty
Secondary Outcome Measures
Efficacy of pain control
Efficacy of pain control measured by
the amount of morphine which the patient needed to keep pain score 2-3
patient global assessment
patient satisfaction assessed by visual analogue scale
incidence of adverse effect such as pruritus, nausea and vomiting,...
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01219062
Brief Title
Postoperative Pain Control After Hip Hemiarthroplasty: Intrathecal Morphine vs Periarticular Infiltration of Bupivacaine
Official Title
Comparative of Postoperative Pain Control at 24 and 48 Hours Between Intrathecal 0.1 mg. of Morphine or Local Infiltration of 20 ml. of 0.25% Bupivacaine in Patients Post Hip Hemiarthroplasty Under Spinal Anesthesis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Surgeon team were not happy with the study protocol, the periarticular injection of local anesthetics
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
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)
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
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
Demographic data : age, sex, Body Weight, Body Mass Index (BMI), ...
Pain score every 3 hours postoperatively in the first 6 hours and at the 12th hours by visual analogue scoring system
Patient global assessment and patient satisfactory visual analogue scoring system at 24th and 48th hour
the amount of morphine during 24 and 48 hours postoperative and the time of first dose they received
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
The patient will be performed spinal anesthesia alone, with postoperative PCA
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
The patient will received intrathecal Morphine for 0.1 mg. in Isobaric bupivacaine in spinal anesthesia and postoperative PCA
Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
morphine
Intervention Description
periarticular infiltration with 0.25% Bupivacaine for 20 ml.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
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
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA
Primary Outcome Measure Information:
Title
The Amount of Morphine consumption after Hemiarthroplasty
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Efficacy of pain control
Description
Efficacy of pain control measured by
the amount of morphine which the patient needed to keep pain score 2-3
patient global assessment
patient satisfaction assessed by visual analogue scale
incidence of adverse effect such as pruritus, nausea and vomiting,...
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thitima Chinachoti, MD
Organizational Affiliation
Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Thitima Chinachot
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
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Postoperative Pain Control After Hip Hemiarthroplasty: Intrathecal Morphine vs Periarticular Infiltration of Bupivacaine
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