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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01219062

Enrollment

Registered

2010-10-13

Start date

2010-09-30

Completion date

2011-04-30

Last updated

2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Neck Fracture

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

Interventions

DRUGmorphine

periarticular infiltration with 0.25% Bupivacaine for 20 ml.

OTHERcontrol

the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)

DRUGBupivacaine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
The Amount of Morphine consumption after Hemiarthroplasty	24 hours

Secondary

Measure	Time frame	Description
Efficacy of pain control	48 hours	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,...

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026