Continuous Pericapsular Nerve Group Block in Hip Fracture Patients

NCT03885739 | Completed

• 1 other identifier: UdeA1004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Background- Despite clinical guidelines favoring surgical repair of hip fracture (HF) within 48 hours of injury, patients may wait considerable periods of time for their turn in the operating room. In this context, continuous nerve blocks are an attractive alternative for pain management. However, the ideal block technique is not yet defined. Recently a new ultrasound-guided approach for selective blockade of the articular branches to the hip, the PENG (Pericapsular Nerve Group) block, has been proposed with potentials advantages for perioperative hip fracture analgesia. Objective- To describe the analgesic efficacy and feasibility of continuous Pericapsular Nerve Group block (CPENGB) in patients with HF. Design-Interventional study. Setting-Academic Level 3 center. Methods- Two experienced anesthesiologist completed 15 sonographically guided Pericapsular Nerve Group (PENG) injections and catheter insertion in patients with severe pain awaiting HF surgery. Each injection consisted of 20 mL of local anesthetics followed by a 0.1% bupivacaine continuous infusion at a constant rate of 8 ml per hour. Pain at rest and on 15° leg lift of the fractured leg were assessed before procedure, 10 and 30 minutes after block performance, and each 24 hours until surgery. A reduction of severe or moderate dynamic pain to mild pain or no pain, and a pain relief of 2 (moderate) were clinically significant findings. To determine feasibility time and number of attempts to perform the procedure were measured.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (5)

• Verbal Rating Scale with four response categories, VRS-4

  Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg)

  Before procedure

• Verbal Rating Scale with four response categories, VRS-4

  Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg)

  10 minutes after procedure

• Verbal Rating Scale with four response categories, VRS-4

  Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg)

  30 minutes after procedure

• Verbal Rating Scale with four response categories, VRS-4

  Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg)

  24 hours after procedure

• Verbal Rating Scale with four response categories, VRS-4

  Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg)

  48 hours after procedure

Study Arms (1)

Patients with hip fracture

OTHER

15 consecutive HF patients who were admitted to a single level 3 center and who report severe pain despite a standardized analgesia protocol. Patients were assessed by the Pain Service as part of a multidisciplinary care pathway and a Continuous Pericapsular Nerve Group blocks was offered as a component of a multimodal analgesic regimen.

Other: Continuous Pericapsular Nerve Group block

Interventions

Continuous Pericapsular Nerve Group block OTHER

Continuous Pericapsular Nerve Group block to standardize the approach. Injections were performed using a curvilinear low-frequency ultrasound probe (3.5- to 5-MHz). The lateral border of iliopsoas tendon in an oblique axial plane at level of iliopectineal eminence provides target for needle placement. Toggling the transducer was necessary to optimize visualization of the iliopsoas tendon secondary to anisotropy. Injections were performed using an 18-gauge Tuohy needle under sterile conditions. Then, 10 mL 0.25% bupivacaine was administered and a 20-G polyamide catheter (connect to a filter) was advanced into the space. The end point of the catheter placement was the direct visualization of microbubbles in a peritendinous distribution using a bolus of agitated saline applied through threaded catheter connected to not purged filter. After catheter placement patients received a 0.1% bupivacaine continuous infusion at a constant rate.

Patients with hip fracture

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Acute hip fractures
• Severe pain
• Patients, or their legal representatives, provided written informed consent for procedure.

You may not qualify if:

• Women in pregnancy
• Trauma score greater than or equal to 16
• Incomplete data

Sponsors & Collaborators

• Adriana Margarita Cadavid: lead

Study Sites (1)

hospital universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist. Specialist in Pain Medicine. Director and Clinical Professor of the Subspecialty in Pain Medicine, University of Antioquia

Model Details: interventional study.

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 22, 2019
• Study Start: October 1, 2018
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

CO (1)