Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block (PTA-ALR)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
FIB
ESPB
spinal anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- primary THR
- informed consent
Exclusion Criteria:
- allergies to study drugs
- spinal anesthesia contraindicated
- kidney failure
- epilepsy, psychiatric disease, neurologic deficits
- revision surgery
- neuropathies in the lumbar area
- no informed consent
- pregnancy
- alcohol/opioid abuse
- emergency surgery/intensive care
Sites / Locations
- Aast Papa Giovanni Xxiii
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
FIB
ESPB
Arm Description
ultrasound guided Fascia Iliaca Block
ultrasound guided Erector Spinae Plane Block
Outcomes
Primary Outcome Measures
morphine
milligrams of morphine consumed in the first postoperative day
Secondary Outcome Measures
perceived postoperative pain: Numeric Rating Scale (NRS)
11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
perceived postoperative pain: Numeric Rating Scale (NRS)
11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
side effects
occurrence of nausea/vomiting, ileum, pruritus and urinary retention in the first 48 hours
Full Information
NCT ID
NCT04574154
First Posted
January 8, 2020
Last Updated
November 28, 2021
Sponsor
Papa Giovanni XXIII Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04574154
Brief Title
Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block
Acronym
PTA-ALR
Official Title
Regional Anesthesia in THR - Comparing Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
August 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Papa Giovanni XXIII Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. However, no studies investigated the analgesic superiority of either FIB or ESPB. In our study the investigators compare FIB and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FIB
Arm Type
Experimental
Arm Description
ultrasound guided Fascia Iliaca Block
Arm Title
ESPB
Arm Type
Experimental
Arm Description
ultrasound guided Erector Spinae Plane Block
Intervention Type
Procedure
Intervention Name(s)
FIB
Intervention Description
FIB with ultrasound: Ropivacaine 0.5% 40 ml
Intervention Type
Procedure
Intervention Name(s)
ESPB
Intervention Description
ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml
Intervention Type
Procedure
Intervention Name(s)
spinal anesthesia
Intervention Description
bupivacaine 0,5% 2.2 ml
Primary Outcome Measure Information:
Title
morphine
Description
milligrams of morphine consumed in the first postoperative day
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
perceived postoperative pain: Numeric Rating Scale (NRS)
Description
11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
Time Frame
24 hs
Title
perceived postoperative pain: Numeric Rating Scale (NRS)
Description
11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
Time Frame
48 hours
Title
side effects
Description
occurrence of nausea/vomiting, ileum, pruritus and urinary retention in the first 48 hours
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary THR
informed consent
Exclusion Criteria:
allergies to study drugs
spinal anesthesia contraindicated
kidney failure
epilepsy, psychiatric disease, neurologic deficits
revision surgery
neuropathies in the lumbar area
no informed consent
pregnancy
alcohol/opioid abuse
emergency surgery/intensive care
Facility Information:
Facility Name
Aast Papa Giovanni Xxiii
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block
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