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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01219088
Enrollment
80
Registered
2010-10-13
Start date
2010-09-30
Completion date
2012-09-30
Last updated
2011-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Neck Fractures

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

Interventions

DRUGBupivacaine, 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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frame
The amount of morphine consumption.24 hours postoperative

Secondary

MeasureTime frameDescription
Efficacy of pain control48 hours postoperativeEfficacy 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

Countries

Thailand

Contacts

Primary ContactThitima Chinachoti, M.D.
sitci35@gmail.com66813082438
Backup ContactSathit Chairatthanawanit, M.D.
sathit13@hotmail.com66817902397

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026