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

Overview

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 Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2012

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

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • The amount of morphine consumption.
    • Time Frame: 24 hours postoperative

Secondary Measures

  • Efficacy of pain control
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Provider of Information About this Clinical Study
    • Assoc. Prof. Thitima Chinachoti, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
  • Overall Official(s)
    • Thitima Chinachoti, M.D., Principal Investigator, Mahidol University
  • Overall Contact(s)
    • Thitima Chinachoti, M.D., 66813082438, sitci35@gmail.com

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