Clinical trial NCT01219062: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Femoral Neck Fracture
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The Amount of Morphine consumption after Hemiarthroplasty
timeFrame: 24 hours
Secondary outcomes:
measure: Efficacy of pain control
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
city: Bangkok
country: Thailand
facility: Thitima Chinachot
Study officials:
affiliation: Siriraj Hospital
name: Thitima Chinachoti, MD
role: PRINCIPAL_INVESTIGATOR
References: