Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw

NCT ID: NCT01219088

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-09-30

Brief Summary

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Falls are a common problem in elderly patients resulting fractured femur, which require early operation. Adequate postoperative pain control will provide good recovery. The investigators will compare the efficacy of postoperative pain control among intrathecal morphine, femoral nerve block, and periarticular infiltration with bupivacaine in patients undergone intramedullary hip screw under spinal anesthesia.

Detailed Description

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Study methods :

Every patients without any exclusion criteria will be performed spinal anesthesia by 0.5% heavy bupivacaine then divided into 4 groups

1. Controlled group : spinal anesthesia alone
2. Femoral nerve block by 20 mL of 0.25% bupivacaine before spinal anesthesia
3. Spinal anesthesia plus 0.1 mg morphine intrathecally
4. Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine

All patients will receive postoperative intravenous patient controlled analgesia (IV PCA) morphine for 48 hours.

Data collection

1. Demographic data
2. Pain score : preoperative, 3 hours postoperative in the 1st six hours, 12 hours postoperative by visual analog scoring system (VASS)
3. Patient global assessment and patient satisfactory VASS at 24 and 48 hours postoperative
4. The amount of morphine at 24 and 48 hours postoperative and the time of the 1st dose

Conditions

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Femoral Neck Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Controlled group

Spinal anesthesia with 0.5% bupivacaine alone

Group Type NO_INTERVENTION

Bupivacaine, morphine

Intervention Type DRUG

1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration

Femoral nerve block

Spinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine, morphine

Intervention Type DRUG

1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration

Intrathecal morphine

Spinal anesthesia plus 0.1 mg of intrathecal morphine

Group Type ACTIVE_COMPARATOR

Bupivacaine, morphine

Intervention Type DRUG

1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration

Periarticular bupivacaine infiltration

Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine, morphine

Intervention Type DRUG

1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration

Interventions

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Bupivacaine, morphine

1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-90 years old
* good consciousness, well co-operated, can use PCA machine
* ASA class 1-3
* no contraindication of spinal anesthesia
* accept for spinal anesthesia
* body weight \> 30 kg
* BMI 20-35 kg/m2
* no history of research-drug allergy

Exclusion Criteria

* previous history of hip surgery (the same side)
* pathological fractured such as severe infection, bone cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

Principal Investigators

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Thitima Chinachoti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of Medicine Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Thitima Chinachoti, M.D.

Role: CONTACT

66813082438

Sathit Chairatthanawanit, M.D.

Role: CONTACT

66817902397

Facility Contacts

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Thitima Chinachoti, MD

Role: primary

6681-3082438

References

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Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

Reference Type DERIVED
PMID: 33238043 (View on PubMed)

Other Identifiers

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Si392/2010

Identifier Type: -

Identifier Source: org_study_id

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