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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05796804
Other study ID # 030/23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 13, 2023
Est. completion date March 31, 2024

Study information

Verified date April 2023
Source Papa Giovanni XXIII Hospital
Contact Dario Bugada
Phone +393405230454
Email dariobugada@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Erector Spinae Plane Block (ESPB) and PENG (pericapsular nerve group block) are alternative approaches to the hip sensitive nerve branches that resulted to be very promising for hip surgeries. However, no studies investigated the analgesic superiority of either PENG or ESPB. In our study the investigators compare PENG (with a lateral femoral cutaneous nerve block) and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - primary total hip replacement - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
ERECTOR SPINAE PLANE BLOCK
ULTRASOUND GUIDED - ROPIVACAINE 30 ml 0.5%
Peng block + lateral femoral cutaneous nerve block
ULTRASOUND GUIDED - ROPIVACAINE 20 ml 0.5% + 10 ml 0.5%
spinal anesthesia
bupivacaine 0.5% 2.2 ml

Locations

Country Name City State
Italy Aast Papa Giovanni Xxiii Bergamo

Sponsors (1)

Lead Sponsor Collaborator
Papa Giovanni XXIII Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary morphine consumption milligrams of morphine by patient controlled analgesia intravenously 24 hours
Secondary postoperative pain numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain" 48 hours
Secondary neuropathic pain DN4 questionnaire - 4 items questionnaire to investigate the occurrence of neuropathic component 48 hours
Secondary postoperative complications nausea, vomiting, vertigo, blurred vision, syncope, bleeding, falls 48 hours
Secondary chronic postoperative pain numeric rating scale 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain" 3 months
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