PENG Block vs FNB + ONB in Patients Undergoing Hip Fracture Surgery With Contraindications to Neuraxial Anesthesia

NCT06457880 | Completed DMC

• 1 other identifier: Campus Bio-Medico
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to demonstrate the efficacy of PENG block as the main anesthetic technique to manage perioperative analgesia for hip fracture surgery compared to femoral and obturator nerve block in patients with contraindications to spinal anesthesia.

Conditions

Hip Fractures; Pain, Postoperative; Coagulopathy; Comorbidities and Coexisting Conditions

Outcome Measures

Primary Outcomes (3)

• preoperative pain

  Preoperative pain score expressed by numerical rating scale 0-10

  30 minutes

• Pain following regional anesthesia

  Preoperative pain score following regional anesthesia execution expressed by numerical rating scale 0-10

  30 minutes

• Postoperative pain

  Postoperative pain score expressed by a numerical rating scale 0-10

  24 hours

Secondary Outcomes (1)

• Morphine milligrams (mg) consumption

  24 hours

Study Arms (2)

PENG block

EXPERIMENTAL

Before surgery, Patients undergo to ultrasound guided PENG block administering ropivacaine 0.5 % 20 mL.

Procedure: PENG BLOCK

Femoral nerve block + Obturator nerve block

ACTIVE COMPARATOR

Before surgery, Patients undergo to ultrasound guided femoral nerve block (ropivacaine 0.5 % 15 mL) + obturator nerve block (ropivacaine 0.5% 5 mL).

Procedure: Femoral Nerve Block; Procedure: Obturator Nerve Block

Interventions

PENG BLOCK PROCEDURE

Preoperative ultrasound guided PENG block (ropivacaine 0.5 % 20 mL)

PENG block

Femoral Nerve Block PROCEDURE

Preoperative ultrasound guided femoral nerve block (ropivacaine 0.5 % 15 mL)

Femoral nerve block + Obturator nerve block

Obturator Nerve Block PROCEDURE

Preoperative ultrasound guided obturator nerve block (ropivacaine 0.5 % 5 mL)

Femoral nerve block + Obturator nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergo hip surgery
• patients with contraindications at spinal anesthesia

You may not qualify if:

• allergy at local anesthetic
• age under 18 or weight under 30

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Campus Bio Medico

Roma, 00128, Italy

Location

MeSH Terms

Conditions

Hip Fractures; Pain, Postoperative; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director, Anesthesiologist

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

IT (1)