PENG vs Femoral Block for Hip Fracture Analgesia

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Hip Fractures

Treatments: Drug: Bupivacaine , epinephrine Dexamethasone; Procedure: Femoral Block Administration; Procedure: PENG Block Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT07073209

24-07027709

Details and patient eligibility

About

This study aims to compare the Pericapsular Nerve Group (PENG) block with femoral block for hip fracture pain. Participants presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block will receive either a PENG or femoral block. The choice of block will be dictated by a randomized monthly schedule, and all participants presenting during each four-week period will receive the designated block. A sub-group analysis will be performed to determine any difference in efficacy in participants with intracapsular versus extracapsular fractures.

Full description

Each year, 250,000 adults in the US and 1.6 million worldwide suffer hip fractures. Peripheral nerve blocks, including femoral blocks, administered soon after admission to patients presenting with hip fractures have been shown to produce clinically and statistically significant reductions in pain scores, opioid consumption, the incidence of confusional state, and the time to mobilization.

Historically, lower extremity blocks for hip fracture pain have targeted the femoral nerve. The PENG block is a relatively novel ultrasound guided block that was first described in 2018 as an alternative to the more traditional femoral block for regional hip analgesia in hip fracture patients. The PENG block targets articular branches of the obturator nerve and accessory obturator nerve, as well as branches of the femoral nerve, the combination of which richly innervate the anterior hip capsule. In a case series of 5 patients presenting to the Emergency Department with hip fracture pain, the PENG block was demonstrated to be an effective nerve block for hip analgesia by reducing the numerical rating scale pain scores by 7 points on a 10 point scale. A larger study compared the PENG block to placebo, also in hip fracture patients presenting to the Emergency Department, and demonstrated a significant decrease of 3 in the dynamic NRS pain score at 1 and 3 hours post-block. A Cochrane review in 2017 demonstrated femoral blocks to have a 3.4 point reduction in pain scores compared to placebo. No study to date has compared the PENG block to the femoral block for acute hip fracture pain.

This study aims to compare the PENG block with femoral block for acute hip fracture pain in patients upon presentation who have not undergone surgical repair. Patients presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block will receive either a PENG or femoral block. The choice of block will be dictated by a randomized monthly schedule, and all patients presenting during each four-week period will receive the designated block. The primary outcome will be the change in NRS pain score from pre-block to one-hour post-block. Secondary outcomes will include NRS pain scores and opioid consumption for 24 hours post-block. A sub-group analysis will be performed to determine any difference in efficacy in patients with intracapsular versus extracapsular fractures.

This will be a pragmatic study with a multiple crossover cluster-controlled design. In this type of trial an intervention is implemented for all patients for a limited period of time and then substituted with the alternate intervention for a comparable amount of time. The order of intervention will be randomized. The repetition of the study periods, especially if conducted over a period of a year of more, has the effect of reducing time-dependent confounding from background improvements in healthcare and regression to the mean. The Hawthorne effect will be limited in this particular case because both of the interventions are already routinely and interchangeably used in our current practice for hip fracture analgesia. Research consent is usually waived in this type of trial design because the treatment received by subjects is identical to standard care and the exposure within a subject population is based only on time period rather than patient characteristics or consent.

As per current standard of care, all hip fracture patients admitted Monday - Friday, 7AM - 5PM, will be offered an analgesic lower extremity peripheral nerve block. Each month of the study will be randomized to either PENG or femoral block. All patients who consent to a block during each month will receive the designated block.

Data will be collected from the electronic medical record (EMR).

Enrollment: 352 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ≥ 18 years of age.
2. ASA Classification 1-4
3. Documentation of a hip fracture diagnosis along with radiologic read indicating fracture location
4. Written, informed consent for analgesic peripheral block placement

Exclusion criteria

1. Altered mental status to the extent that it limits ability to report pain score
2. Patient or health care proxy refusal of analgesic nerve block
3. Allergy to study medications or contraindication to peripheral nerve block
4. Chronic pain diagnosis on preoperative opioids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

PENG Block Administration

Experimental group

Description:

Policy for the administration of the PENG block as per clinical guidelines to all subjects presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block

Treatment:

Procedure: PENG Block Administration

Drug: Bupivacaine , epinephrine Dexamethasone

Femoral Block Administration

Experimental group

Description:

Policy for the administration of the Femoral block as per clinical guidelines to all subjects presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block

Treatment:

Procedure: Femoral Block Administration

Drug: Bupivacaine , epinephrine Dexamethasone