Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorPoznan University of Medical Sciences

About this trial

This study will compare three versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing hip surgery. The PENG block is a regional anesthesia technique used to reduce pain around the hip joint and may improve early recovery after surgery.

All patients in the study will receive the PENG block using 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of three groups:

Group 1: PENG block using ropivacaine only (no additional medications). Group 2: PENG block using ropivacaine with 4 mg of dexamethasone injected near the nerves.

Group 3: PENG block using ropivacaine with 25 micrograms of dexmedetomidine injected near the nerves.

Dexamethasone and dexmedetomidine are medications that may increase the duration and quality of regional anesthesia. It is not known whether adding one of these medications provides longer-lasting or better pain relief compared to using ropivacaine alone.

The main purpose of this study is to determine whether the addition of dexamethasone or dexmedetomidine improves the effectiveness of the PENG block in relieving pain after hip surgery. The study will evaluate pain levels, opioid consumption, time to first rescue pain medication, need for additional analgesia, and recovery outcomes. Safety, side effects, and any block-related complications will also be monitored.

The investigators hypothesize that adding either perineural dexamethasone or dexmedetomidine will result in longer and more effective pain relief compared with the standard PENG block without an adjuvant.

This research may help identify the most effective form of the PENG block for older adults undergoing hip surgery and contribute to improved pain management, reduced opioid use, and better postoperative recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 65 years or older

Scheduled for elective or emergency hip surgery (e.g., hip fracture fixation or hip arthroplasty)

ASA physical status I-III

Planned use of a PENG block as part of perioperative analgesia

Disqualifiers

Refusal or inability to provide informed consent

Known allergy, intolerance, or contraindication to any of the study medications: ropivacaine, dexamethasone, dexmedetomidine

Pre-existing neurological deficit or neuropathy in the affected limb

Coagulopathy or laboratory abnormality that contraindicates regional anesthesia: INR >1.5, or platelet count <100,000/µL, or therapeutic anticoagulation that cannot be safely paused

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine 0.2% Injectable Solution

    Drug

    20 mL of 0.2% ropivacaine administered perineurally as part of the PENG block. No perineural or intravenous adjuvant drugs will be used in this arm.

  • Dexamethasone 4mg

    Drug

    4 mg of dexamethasone administered perineurally together with 20 mL of 0.2% ropivacaine for the PENG block. No intravenous dexamethasone will be administered.

  • Dexmedetomidine

    Drug

    25 micrograms of dexmedetomidine administered perineurally together with 20 mL of 0.2% ropivacaine for the PENG block. No intravenous dexamethasone will be administered.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: PENG Block With Ropivacaine Only (Control)Active comparator 1 intervention
Group B: PENG Block With Perineural DexamethasoneActive comparator 1 intervention
Group C: PENG Block With Perineural DexmedetomidineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to First Rescue Analgesia

Time (in hours) from completion of the PENG block to the first administration of a rescue analgesic (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS).

Time frame
Within 48 hours after surgery.

Secondary outcomes

1

Pain Intensity at Rest (NRS 0-10)

Pain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.

Time frame
4 hours after surgery.
2

Pain Intensity at Rest (NRS 0-10)

ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.

Time frame
8 hours after surgery.
3

Pain Intensity at Rest (NRS 0-10)

ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.

Time frame
12 hours after surgery.
4

Pain Intensity at Rest (NRS 0-10)

ain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values will be compared between groups across predefined time points.

Time frame
24 hours after surgery.

Other outcomes

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