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

NCT ID: NCT04996979

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2022-12-31

Brief Summary

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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 .

Detailed Description

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Specific Aim1: To determine difference in pain scores on movement (dynamic pain scores) in patients who receive the PENG block in the intervention group compared to no block in the control group at 30 minutes after performance of the block.

Specific Aim2: To determine if there is any difference in pain at rest between the intervention group and the control group, and if so, the magnitude of the difference in pain scores.

Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Patient, nurses and CRC will be blinded. Rest of study team is not blinded.

Study Groups

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Control

Only standard care

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Standard care

Intervention group

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

Group Type EXPERIMENTAL

Ropivacaine 0.5% Injectable Solution

Intervention Type DRUG

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

Interventions

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Ropivacaine 0.5% Injectable Solution

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

Intervention Type DRUG

Placebo

Standard care

Intervention Type DRUG

Other Intervention Names

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Standard care

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients with cognitive impairment or inability to give consent, or refusal to give consent
2. Multiple fracture cases
3. Peri-prosthetic fractures and revisions
4. Subclinical vertebral fractures
5. Hip fractures due to major accidents such as road traffic accidents, fall from height or more than 2 meters
6. Multiple trauma
7. Pathological fractures secondary to metastases
8. 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pain Management Center Sinagpore General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Facility Contacts

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Diana Xin Hui Chan

Role: primary

References

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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.

Reference Type RESULT
PMID: 27075376 (View on PubMed)

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.

Reference Type RESULT
PMID: 30063657 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37055189 (View on PubMed)

Related Links

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https://doi.org/10.1093/bjaceaccp/mkt006

Anaesthetic management of patients with hip fractures: an update

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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