Patients With Acute Hip Fractures Will Receive Either the PENG Block or no Block Respectively.

NCT04996979 | Unknown DMC

• 1 other identifier: 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fracture pain is often severe and traditionally managed by systemic opioids which have increased risk of side effects in frail elderly patients. Inadequately controlled pain may lead to delirium which increases mortality and morbidity. The overall aim of this RCT is to investigate the potential for improved pain relief accomplished by the addition of the PENG block to current standard practice of pre-operative analgesia (systemic morphine), compared to the control group, which involves no block (operator will still go through the motion as if performing a block) plus standard pre-operative analgesia. The investigator hypothesize that the addition of a single shot PENG block at the side of hip fracture in addition to traditional systemic morphine provides good preoperative pain relief on movement and reduces the need for breakthrough opioid requirements. The investigator hypothesize that the interventional group dynamic pain score assessed at 30 minutes after the block compared to control group dynamic pain score at 30 minutes after the "block" will be at least a 3 point difference between the 2 groups .

Conditions

Hip Fractures

Keywords

Hip fractures, elderly, pain

Outcome Measures

Primary Outcomes (1)

• Dynamic pain scores (Numerical pain score (NRS) at 15 degrees leg lift)

  The difference in dynamic pain scores (NRS at 15 degrees leg lift) at 30 minutes post block performance in the intervention group vs the control group. Assessment of the dynamic pain score is done prior to discharge from recovery at SGH Pain Management Centre.

  30 minutes after receiving intervention

Secondary Outcomes (3)

• Pain scores (NRS) at rest (static pain) and on movement (dynamic pain)

  Up to 24 hours from performance of block

• Pain scores collected to estimate the onset and duration of block Pain scores to estimate the onset and duration of block

  Up to 24 hours from performance of block

• Total opioid use over 24 hours as a surrogate measure

  Up to 24 hours from performance of block

Study Arms (2)

Control

PLACEBO COMPARATOR

Only standard care

Drug: Placebo

Intervention group

EXPERIMENTAL

The PENG block was performed for intervention group with local anaesthetic solution composed of 20 ml of ropivacaine 0.5%.

Drug: Ropivacaine 0.5% Injectable Solution

Interventions

Ropivacaine 0.5% Injectable Solution DRUG

Local anaesthetic solution composed of ropivacaine 0.5%(intervention group)

Intervention group

Placebo DRUG

Standard care

Also known as: Standard care

Control

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years old and above
• Provided consent for the study
• Patients with solitary hip fracture (no other fracture) - intracapsular neck of femur fracture, intertrochanteric fracture
• Either awaiting hip fracture surgery or no plans for hip fracture surgery within the next 24 hours

You may not qualify if:

• Patients with cognitive impairment or inability to give consent, or refusal to give consent
• Multiple fracture cases
• Peri-prosthetic fractures and revisions
• Subclinical vertebral fractures
• Hip fractures due to major accidents such as road traffic accidents, fall from height or more than 2 meters
• Multiple trauma
• Pathological fractures secondary to metastases
• Patients with contraindications to block performance
• Coagulopathy as demonstrated by PT/PTT/INR
• On antiplatelets or anticoagulation
• Infection/ compromised skin integrity at site of block performance
• Allergy to local anaesthetics and opioids

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Pain Management Center Sinagpore General Hospital

Singapore, 169608, Singapore

RECRUITING

Related Publications (3)

• Tay E. Hip fractures in the elderly: operative versus nonoperative management. Singapore Med J. 2016 Apr;57(4):178-81. doi: 10.11622/smedj.2016071.

  PMID: 27075376 RESULT

• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

  PMID: 30063657 RESULT

• Lin X, Liu CW, Goh QY, Sim EY, Chan SKT, Lim ZW, Chan DXH. Pericapsular nerve group (PENG) block for early pain management of elderly patients with hip fracture: a single-center double-blind randomized controlled trial. Reg Anesth Pain Med. 2023 Nov;48(11):535-539. doi: 10.1136/rapm-2022-104117. Epub 2023 Apr 13.

  PMID: 37055189 DERIVED

Related Links

• Anaesthetic management of patients with hip fractures: an update

MeSH Terms

Conditions

Hip Fractures; Pain

Interventions

Ropivacaine; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient, nurses and CRC will be blinded. Rest of study team is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: August 9, 2021
• Study Start: May 24, 2021
• Primary Completion: May 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

SG (1)