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

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

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.

Study Overview

• Status: Terminated
• Conditions: Femoral Neck Fracture
• Intervention / Treatment: Other: control; Drug: morphine; Drug: Bupivacaine

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine Siriraj Hospital
  • Bangkok, Thailand, 10700
    • Thitima Chinachot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Thitima Chinachoti, MD, Faculty of Medicine Siriraj Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: October 12, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 4, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Pain, Postoperative; Femoral Neck Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: Si391/2010