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

Phase 4

Terminated

• Conditions: Femoral Neck Fracture
• Interventions: Other: control; Drug: morphine; Drug: Bupivacaine

• Registration Number: NCT01219062
• Lead Sponsor: Mahidol University

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

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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	The patient will be performed spinal anesthesia alone, with postoperative PCA
Morphine	morphine	The patient will received intrathecal Morphine for 0.1 mg. in Isobaric bupivacaine in spinal anesthesia and postoperative PCA
bupivacaine	Bupivacaine	the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA

Primary Outcome Measures

Name	Time	Method
The Amount of Morphine consumption after Hemiarthroplasty	24 hours

Secondary Outcome Measures

Name	Time	Method
Efficacy of pain control	48 hours	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,...

Trial Locations

Locations (2)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Thitima Chinachot; 🇹🇭 Bangkok, Thailand