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

Mahidol University

Status and phase: Terminated; Phase 4

Conditions: Femoral Neck Fracture

Treatments: Drug: Bupivacaine; Drug: morphine; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT01219062

Si391/2010

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 3 patient groups, including a placebo group

control

Placebo Comparator group

Description:

The patient will be performed spinal anesthesia alone, with postoperative PCA

Treatment:

Other: control

Morphine

Active Comparator group

Description:

The patient will received intrathecal Morphine for 0.1 mg. in Isobaric bupivacaine in spinal anesthesia and postoperative PCA

Treatment:

Drug: morphine

bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine