Postoperative Pain Control After Hip Hemiarthroplasty: In... | NCT01219062

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

NCT01219062

Sponsor

Mahidol University

Status

Terminated

Last Update Posted

Oct 4, 2016Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Femoral Neck Fracture

Interventions

morphine
control
Bupivacaine

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Surgeon team were not happy with the study protocol, the periarticular injection of local anesthetics

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Sep 15, 2010

First Submission Date that Met QC Criteria

Oct 12, 2010

First Posted Date

Oct 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2016

Last Update Posted Date

Oct 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aphichat Suphathamwit,, Lecturer, Mahidol UniversityPrincipal Investigator

Lead Sponsor

Mahidol UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	Placebo Comparator	The patient will be performed spinal anesthesia alone, with postoperative PCA	Other: control
Morphine	Active Comparator	The patient will received intrathecal Morphine for 0.1 mg. in Isobaric bupivacaine in spinal anesthesia and postoperative PCA	Drug: morphine
bupivacaine	Active Comparator	the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA	Drug: Bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
morphine	Drug	periarticular infiltration with 0.25% Bupivacaine for 20 ml.	Morphine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Amount of Morphine consumption after Hemiarthroplasty		24 hours

Secondary Outcomes

Measure	Description	Time Frame
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,...	48 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thitima Chinachoti, MD	Siriraj Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hospital		Bangkok		10700	Thailand
Thitima Chinachot

Condition Browse Module

MeSH Terms

ID	Term
D005265	Femoral Neck Fractures

Ancestor Terms

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009020	Morphine
D002045	Bupivacaine

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided