PENG: an Estimation of ED50 in Neck of Femur Fracture

NCT05095025 | Unknown

• 1 other identifier: PENG Dose 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The effective dose of local anaesthetic used in PENG blocks to achieve analgesia in patients with fractured neck of femur is unknown. It is planned to address this question using a dixon/massey sequential dosing methodology to establish the ED50 of 0.25% Bupivacaine.

Conditions

Hip Fractures; Pain, Acute

Keywords

bupivacaine; dose; PENG Block; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Analgesic success

  Verbal rated pain score of ≤3/10 30 minutes after the administration of a predetermined dose of bupivacaine via a continuous PENG catheter

  30 minutes

Secondary Outcomes (1)

• Analgesic failure

  30 minutes

Other Outcomes (1)

• Effective dose in 50 % of participants

  30 minutes

Study Arms (1)

Bupivacaine dose finding

EXPERIMENTAL

Sequential up and down dose modification based on the outcome of the intervention in the preceding participant

Drug: Bupivacaine Hydrochloride 20ml injectate

Interventions

Bupivacaine Hydrochloride 20ml injectate DRUG

Sequential dosing, starting at 50mg with 5mg increments based on the outcome of the preceding participant

Also known as: Sequential up and down dosing

Bupivacaine dose finding

Eligibility Criteria

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

You may qualify if:

• All patients scheduled for operative repair of hip fracture
• Patient age 18 years or more
• ASA I - III

You may not qualify if:

• Patient refusal
• Coagulopathy
• Local infection
• Allergy to Local Anaesthetics
• Significant cognitive impairment (4AT score\>=4 or otherwise unable to provide consent)
• Previous RA procedure within 24hours with ongoing analgesia
• Weight \<50kg

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Cork University Hospital

Cork, Ireland

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Acute Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Brian O'Donnell, MD

  UCC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian D O'Donnell, MD

CONTACT

+353872780225; briodnl@gmail.com

Aohgan O'Muirheartaigh, MD

CONTACT

md

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The assessor and the patient will be unaware of the dose of bupivacaine administered. The bupivacaine solution will be prepared by an investigator other than those involved in the performance of the PENG block or the assessment of block outcome.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist

Model Details: Using a sequential step-up, step-down dosing model the dose of bupivacaine administered will be determined by the response of the preceding patient. Each participant will receive a total injectate volume of 20ml. Based upon the published efficacy literature, the starting dose of bupivacaine will be 50mg. The dose of bupivacaine will be adjusted by 5mg up or down based on the outcome (analgesic success or failure) of each subsequent participant.

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 27, 2021
• Study Start: September 14, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)