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

NCT01219062 | Terminated Phase 4

• 1 other identifier: Si391/2010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Femoral Neck Fracture

Outcome Measures

Primary Outcomes (1)

• The Amount of Morphine consumption after Hemiarthroplasty

  24 hours

Secondary Outcomes (1)

• Efficacy of pain control

  48 hours

Study Arms (3)

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

morphine DRUG

periarticular infiltration with 0.25% Bupivacaine for 20 ml.

Morphine

control OTHER

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

control

Bupivacaine DRUG

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

bupivacaine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (2)

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

Thitima Chinachot

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Morphine; Bupivacaine

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Thitima Chinachoti, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: October 13, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

TH (2)