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

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Femoral Neck Fractures

Treatments: Drug: Bupivacaine, morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT01219088

Si392/2010

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

Controlled group

No Intervention group

Description:

Spinal anesthesia with 0.5% bupivacaine alone

Treatment:

Drug: Bupivacaine, morphine

Femoral nerve block

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine, morphine

Intrathecal morphine

Active Comparator group

Description:

Spinal anesthesia plus 0.1 mg of intrathecal morphine

Treatment:

Drug: Bupivacaine, morphine

Periarticular bupivacaine infiltration

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine, morphine