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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03860324
Other study ID # 45149
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date December 31, 2019

Study information

Verified date August 2021
Source Hospital Beatriz Ângelo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The thoracic erector spinae plane (ESP) block was first described by Forero et al in September 2016. In their article, the authors presented the possibility of using this block as an option for the control of thoracic neuropathic pain as well as post-operative thoracic pain. The ESP block is done by administering local anesthetic in the plane deep to the erector spinae muscle, which spreads through the costotransverse foramen to the dorsal and ventral roots of the spinal nerves. Since then, there have been reports about the successful use of this block for bariatric surgery, ventral hernia repair, radical mastectomy, rib fractures, major abdominal surgery and hip replacement. However, there are no studies in the literature comparing the efficacy of the ESP block to other nerve blocks. The purpose of this study is to compare the post-operative analgesic efficacy of the ESP block to the fascia iliaca (FI) block after total hip replacement (THR).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Surgical plan for total hip replacement - Signing of consent form to participate in the study Exclusion Criteria: - Patient refusal - BMI > 40 kg/m2 - Surgical plan for revision of hip replacement - Patient unable to quantify pain level - Chronic kidney disease with a Glomerular Filtration Rate < 50ml/min - Previously medicated with opioids - Patient unable to perform the surgery with spinal block - Allergy to local anesthetics - Infection in the site of the Erector Spinae Plane or Fascia Iliaca block - Allergy or contraindication to the use of morphine

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Single-shot erector spinae plane block
Single-shot Erector Spinae Plane block with 30ml of ropivacaine 0,5% + adrenaline 150mcg.
Single-shot fascia iliaca block
Single-shot Fascia Iliaca block with 40ml of ropivacaine 0,2%

Locations

Country Name City State
Portugal Hospital Beatriz Ângelo Loures Lisboa

Sponsors (1)

Lead Sponsor Collaborator
Hospital Beatriz Ângelo

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative pain level measured by the Visual Analog Scale Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain) At 6 hours post-operative
Primary Post-operative pain level measured by the Visual Analog Scale Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain) At 12 hours post-operative
Primary Post-operative pain level measured by the Visual Analog Scale Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain) At 24 hours post-operative
Primary Post-operative pain level measured by morphine consumption using patient-controlled intravenous analgesia Total amount (in mg) of morphine administered by a patient-controlled intravenous analgesia pump of morphine 1mg/ml with bolus of 1ml per patient request with a lockout time of 10 minutes At 24 hours post-operative
Secondary Muscle Strength grade Muscle strength grade and comparison with the contralateral limb in the quadriceps femoris muscle
Muscle strength scale:
Grade 0: No muscle contraction is detected Grade 1: Muscle contraction is identified but it is insufficient to produce motion Grade 2: The muscle can move the joint only if the force of gravity is eliminated Grade 3: The muscle can move the joint against gravity but without any resistance Grade 4: The muscle can move the joint against moderate resistance Grade 5: The muscle can move the joint against full resistance
At 12 hours post-operative
Secondary Muscle Strength grade Muscle strength grade and comparison with the contralateral limb in the quadriceps femoris muscle
Muscle strength scale:
Grade 0: No muscle contraction is detected Grade 1: Muscle contraction is identified but it is insufficient to produce motion Grade 2: The muscle can move the joint only if the force of gravity is eliminated Grade 3: The muscle can move the joint against gravity but without any resistance Grade 4: The muscle can move the joint against moderate resistance Grade 5: The muscle can move the joint against full resistance
At 24 hours post-operative
Secondary Sensory block assessed through a temperature test Assessment of sensory block through a temperature test and comparison with the contralateral limb (sensory block vs no sensory block) At 24 hours post-operative
Secondary Sensory block assessed through a tactile stimulation test Assessment of sensory block through a tactile stimulation test and comparison with the contralateral limb (sensory block vs no sensory block) At 24 hours post-operative
Secondary Detection of side effects related to the anesthetic and analgesic technique namely pruritus, urinary retention, nausea and vomiting in each patient Presence of side effects (pruritus, urinary retention, nausea/vomiting) At 24 hours post-operative
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