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

• Sponsor: Mahidol University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01219088
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 4
• Duration (Months): 24
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Femoral Neck Fractures	Drug: Bupivacaine, morphine	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Post Operative Pain Control Among Intrathecal 0.1 mg Morphine, Femoral Nerve Block, or Periarticular Infiltration of 20 mL of 0.25% Bupivacaine in Patients Post Intramedullary Hip Screw
• Study Start Date: Sep 1, 2010
• Anticipated Primary Completion Date: Sep 1, 2012
• Anticipated Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Controlled group Spinal anesthesia with 0.5% bupivacaine alone	Drug: 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
Active Comparator: Femoral nerve block Spinal anesthesia plus femoral nerve block with 20 mL of 0.25% bupivacaine	Drug: 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
Active Comparator: Intrathecal morphine Spinal anesthesia plus 0.1 mg of intrathecal morphine	Drug: 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
Active Comparator: Periarticular bupivacaine infiltration Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine	Drug: 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

Outcome Measures

Primary Outcome Measures

1. The amount of morphine consumption. [24 hours postoperative]

Secondary Outcome Measures

1. Efficacy of pain control [48 hours postoperative]

   Efficacy of pain control measured by The amout of morphine consumption Visual analogue pain scale Patient satisfaction by patient global assessment Incidences of adverse events : nausea, vomiting, pruritus

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Siriraj Hospital	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Thitima Chinachoti, M.D., Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01219088
• Other Study ID Numbers: Si392/2010
• First Posted: Oct 13, 2010
• Last Update Posted: Aug 4, 2011
• Last Verified: Aug 1, 2011

• Additional relevant MeSH terms: Femoral Neck Fractures; Morphine; Bupivacaine

Study Results

No Results Posted as of Aug 4, 2011