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

Study Overview
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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 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

Official Title
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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

Conditions
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Femoral Neck Fracture

Intervention / Treatment
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* Drug: morphine
* Other: control
* Drug: Bupivacaine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>The patient will be performed spinal anesthesia alone, with postoperative PCA | Other: control<br>* the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)<br>|
| Active Comparator: Morphine<br>The patient will received intrathecal Morphine for 0.1 mg. in Isobaric bupivacaine in spinal anesthesia and postoperative PCA | Drug: morphine<br>* periarticular infiltration with 0.25% Bupivacaine for 20 ml.<br>|
| Active Comparator: bupivacaine<br>the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA | Drug: Bupivacaine<br>* the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 |