Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOspedale Edoardo Bassini

About this trial

This prospective, randomized controlled trial aims to compare two multimodal regional anesthesia strategies for postoperative analgesia in elective total hip arthroplasty (THA) performed via anterior approach. Patients will be randomized to receive either a Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block, or a PENG block combined with wound infiltration (WI).

The primary outcome is postoperative pain intensity at rest, measured by Numerical Rating Scale (NRS) at 6 hours after surgery. Secondary outcomes include dynamic pain scores at 6, 24, and 48 hours, total opioid consumption, time to first rescue analgesia, quadriceps strength, hip flexion angle, length of stay, and adverse events.

All procedures are routinely used in clinical practice and carry minimal additional risk. Safety will be continuously monitored by the Principal Investigator and the study team according to an internal Safety Monitoring Plan.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Elective total hip arthroplasty

Spinal (subarachnoid) anesthesia

Written informed consent provided by the patient or by the legal guardian, if appointed

Disqualifiers

INR > 1.5

aPTT > 1.5

Platelet count < 75,000/mm³

Signs suggestive of infection at the puncture site

Trial design

Design model

Parallel

Treatments tested in this trial

  • PENG plus LFCN block

    Procedure/Surgery

    The experimental arm will be subjected to a combination of peripheral blocks: the interfascial block of the PENG and the perinervous block of the LFCN The PENG block involves deposition of local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus. The LFCN block consists of applying local anesthetic near the nerve. The LFCN lies in the subcutaneous plane deep to the fascia lata below the anterior superior ischiatic spine.

  • PENG plus WI

    Procedure/Surgery

    The control arm will receive a combination of pericapsular nerve group (PENG) block and wound infiltration (WI). The PENG block involves the deposition of local anesthetic in the fascial plane between the psoas tendon and the superior pubic ramus, under ultrasound guidance. The wound infiltration consists of the administration of local anesthetic into the subcutaneous tissue along the surgical incision

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: PENG - LFCN BlockExperimental treatment 1 intervention
Group B: PENG-WIActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain at rest control at 6h

pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Time frame
six hours after performing the regional anesthesia technique

Secondary outcomes

1

Pain at rest control at 24h

pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Time frame
24 hours after performing the regional anesthesia technique
2

Pain at rest control at 48h

pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Time frame
48 hours after performing the regional anesthesia technique
3

Pain on movement control at 6h

pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Time frame
six hours after performing the regional anesthesia technique
4

Pain on movement control at 24h

pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Time frame
24 hours after performing the regional anesthesia technique

Other outcomes

Sponsors and contacts

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