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

Femoral Neck Fracture Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01219062
• Other study ID #: Si391/2010
• Status: Terminated
• Phase: Phase 4
• First received: September 15, 2010
• Last updated: October 3, 2016
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: October 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Pain, Postoperative

Intervention

Drug:
• morphine
periarticular infiltration with 0.25% Bupivacaine for 20 ml.

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)

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok
Thailand	Thitima Chinachot	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Amount of Morphine consumption after Hemiarthroplasty		24 hours	Yes
Secondary	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	Yes