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

Phase 4

• Conditions: Femoral Neck Fractures
• Interventions: Drug: Bupivacaine, morphine

• Registration Number: NCT01219088
• Lead Sponsor: Mahidol University

Brief Summary

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

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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-10-09
• Study First Posted: 2010-10-13
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-04
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral nerve block	Bupivacaine, morphine	Spinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine
Periarticular bupivacaine infiltration	Bupivacaine, morphine	Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine
Controlled group	Bupivacaine, morphine	Spinal anesthesia with 0.5% bupivacaine alone
Intrathecal morphine	Bupivacaine, morphine	Spinal anesthesia plus 0.1 mg of intrathecal morphine

Primary Outcome Measures

Name	Time	Method
The amount of morphine consumption.	24 hours postoperative

Secondary Outcome Measures

Name	Time	Method
Efficacy of pain control	48 hours postoperative	Efficacy of pain control measured by; 1. The amout of morphine consumption; 2. Visual analogue pain scale; 3. Patient satisfaction by patient global assessment; 4. Incidences of adverse events : nausea, vomiting, pruritus

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand