Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block

Postoperative Pain Clinical Trial

— PTA-ALR  

Official title:

Regional Anesthesia in THR - Comparing Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574154
• Other study ID #: 191-19000
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: August 21, 2021

Study information

• Verified date: November 2021
• Source: Papa Giovanni XXIII Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 21, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• FIB
FIB with ultrasound: Ropivacaine 0.5% 40 ml
• ESPB
ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml
• 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	milligrams of morphine consumed in the first postoperative day	24 hours
Secondary	perceived postoperative pain: Numeric Rating Scale (NRS)	11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"	24 hs
Secondary	perceived postoperative pain: Numeric Rating Scale (NRS)	11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"	48 hours
Secondary	side effects	occurrence of nausea/vomiting, ileum, pruritus and urinary retention in the first 48 hours	48 hours