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

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

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.

Study Overview

• Status: Unknown
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Drug: Bupivacaine, morphine

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Faculty of Medicine Siriraj Hospital
    • Contact: Thitima Chinachoti, MD; Phone Number: 6681-3082438; Email: sitci35@gmail.com
    • Principal Investigator: Thitima Chinachoti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The amount of morphine consumption.	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of pain control	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	48 hours postoperative

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ANTICIPATED): September 1, 2012
• Study Completion (ANTICIPATED): September 1, 2012

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: October 9, 2010
• First Posted (ESTIMATE): October 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 4, 2011
• Last Update Submitted That Met QC Criteria: August 3, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: Si392/2010