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

• Sponsor: Papa Giovanni XXIII Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04574154
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 19
• Patients Per Site Per Month: 3.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: FIB; Procedure: ESPB; Procedure: spinal anesthesia	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized trialrandomized trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Regional Anesthesia in THR - Comparing Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block
• Actual Study Start Date: Jan 20, 2020
• Actual Primary Completion Date: May 15, 2021
• Actual Study Completion Date: Aug 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FIB ultrasound guided Fascia Iliaca Block	Procedure: FIB; FIB with ultrasound: Ropivacaine 0.5% 40 ml; Procedure: spinal anesthesia; bupivacaine 0,5% 2.2 ml
Experimental: ESPB ultrasound guided Erector Spinae Plane Block	Procedure: ESPB; ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml; Procedure: spinal anesthesia; bupivacaine 0,5% 2.2 ml

Outcome Measures

Primary Outcome Measures

1. morphine [24 hours]

   milligrams of morphine consumed in the first postoperative day

Secondary Outcome Measures

1. perceived postoperative pain: Numeric Rating Scale (NRS) [24 hs]

   11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

2. perceived postoperative pain: Numeric Rating Scale (NRS) [48 hours]

   11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

3. side effects [48 hours]

   occurrence of nausea/vomiting, ileum, pruritus and urinary retention in the first 48 hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aast Papa Giovanni Xxiii	Bergamo		Italy	24127

Sponsors and Collaborators

• Papa Giovanni XXIII Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dario Bugada, MD PhD, principal investigator, attending anesthesiologist, Papa Giovanni XXIII Hospital
• ClinicalTrials.gov Identifier: NCT04574154
• Other Study ID Numbers: 191-19000
• First Posted: Oct 5, 2020
• Last Update Posted: Dec 9, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Anesthetics

Study Results

No Results Posted as of Dec 9, 2021