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

Singapore Health Services (SingHealth)

Status: Unknown

Conditions: Hip Fractures

Treatments: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04996979

2

Details and patient eligibility

About

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 .

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Only standard care

Treatment:

Drug: Placebo

Intervention group

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine 0.5% Injectable Solution