Pericapsular Nerve Group Block Versus Intrathecal Morphine for Analgesia After Total Hip Arthroplasty

Comparison of the Efficacy of the Pericapsular Nerve Group (PENG) Block Versus Intrathecal Morphine for Postoperative Analgesia Following Total Hip Arthroplasty

The Pericapsular Nerve Group (PENG) block is an effective method for postoperative pain management in patients undergoing primary total hip arthroplasty (THA) via a posterolateral approach. The application of this technique reduces postoperative opioid requirements, thereby limiting the risk of adverse effects associated with systemic opioid administration. Effective pain control and a reduced incidence of side effects may translate into higher patient satisfaction and a decreased length of hospital stay (LOS). The PENG block serves as an effective component of multimodal analgesia and may provide an alternative to intrathecal morphine in patients undergoing primary total hip arthroplasty via a posterolateral approach, where the primary anesthetic technique is spinal anesthesia with hyperbaric bupivacaine.

Objectives

1. To evaluate the efficacy of the PENG block in postoperative pain control and compare its effectiveness with intrathecal morphine administration.
2. To assess the impact of the PENG block on postoperative opioid consumption in comparison to analgesia achieved via intrathecal morphine.
3. To analyze the incidence of selected adverse effects associated with systemic opioid administration in patients receiving a PENG block versus those in the intrathecal morphine group.
4. To evaluate patient satisfaction levels regarding postoperative pain management across the different analgesic modalities.
5. To analyze the correlation between the type of analgesia employed and the duration of hospitalization.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Hip Disease; Hip Replacement, Total; Perioperative Analgesia
• Intervention / Treatment: Procedure: PNEG block; Procedure: Spinal anesthesia without opioid; Procedure: Spinal anesthesia with opioid; Procedure: Sham PENG block

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mykhailo Kazantsev, MD; Phone Number: 00 48 56 641 4039; Email: mykhailo.kazantsev@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed, written consent for study participation.
• Qualification for elective primary total hip arthroplasty via a posterolateral approach.
• Age above 18 years.
• ASA Physical Status I-III.
• Absence of contraindications to spinal anesthesia.
• Absence of contraindications to performing a Pericapsular Nerve Group (PENG) block.
• Absence of contraindications to the administration of the pharmacological agents utilized in the study.

Exclusion Criteria:

• Absence of informed consent.
• Age below 18 years.
• Psychoactive substance abuse or dependence.
• Chronic opioid therapy.
• Contraindications to spinal anesthesia.
• Contraindications to the Pericapsular Nerve Group (PENG) block.
• Contraindications to the administration of study medications.
• Body Mass Index (BMI) above 30 kg/m^2.
• Pregnancy.
• History of chronic pain management.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENG Group; Spinal anesthesia without opioid + PENG block	Procedure: PNEG block; Pericapsular Nerve Group (PENG) block will be performed using 20 mL of 0.5% ropivacaine (Ropimol, Molteni, Italy), supplemented with 4 mg of dexamethasone (Dexaven, Bausch Health, Ireland).; Procedure: Spinal anesthesia without opioid; Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine (Marcaine Spinal 0.5% Heavy, Aspen Pharma, Ireland).
Active Comparator: MF Group; Spinal anesthesia with opioid and sham PENG Block	Procedure: Spinal anesthesia with opioid; Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine, supplemented with 100 mcg of morphine (Morphini Sulfas WZF 0.1% Spinal, Polpharma, Poland).; Procedure: Sham PENG block; A sham PENG block will be performed using 20 mL of 0.9% sodium chloride solution (Natrium chloratum 0,9% Fresenius, Fresenius Kabi, Poland).
Sham Comparator: Control; Spinal anesthesia without opioid and sham PENG Block	Procedure: Spinal anesthesia without opioid; Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine (Marcaine Spinal 0.5% Heavy, Aspen Pharma, Ireland).; Procedure: Sham PENG block; A sham PENG block will be performed using 20 mL of 0.9% sodium chloride solution (Natrium chloratum 0,9% Fresenius, Fresenius Kabi, Poland).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative oxycodone consumption delivered via patient-controlled analgesia (PCA)	Total amount of oxycodone delivered by the intravenous PCA pump, calculated as the sum of all delivered PCA boluses and reported in milligrams. Lower values indicate lower postoperative opioid requirement.	From end of surgery to 24 hours postoperatively.
Number of patient-initiated PCA demand attempts recorded by the PCA pump	Total number of patient-initiated analgesia requests (button presses) recorded by the intravenous patient-controlled analgesia (PCA) pump. This measure includes all demand attempts, regardless of whether a bolus was delivered. Reported as count.	From end of surgery to 24 hours postoperatively.
Pain intensity at rest measured by the 11-point Numerical Rating Scale (NRS, 0-10)	Patient-reported pain intensity at rest assessed using the 11-point Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain score is recorded at each scheduled assessment time point.	Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.
Dynamic pain assesmnetDynamic pain intensity during passive straight leg raise measured by the 11-point Numerical Rating Scale (NRS, 0-10)	Patient-reported dynamic pain intensity during passive straight leg raise of the operated limb (knee extended and hip flexed to 45°), assessed using the 11-point Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain score is recorded at each scheduled assessment time point.	Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.
Patient satisfaction with postoperative analgesia measured by a 5-point Likert satisfaction scale (1-5)	Patient-reported satisfaction with postoperative analgesia assessed using a 5-point Likert satisfaction scale: = definitely dissatisfied,; = dissatisfied,; = neither satisfied nor dissatisfied (neutral),; = satisfied,; = definitely satisfied. Higher scores indicate greater satisfaction.	At 0, 4, 8, 12, and 24 hours after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea severity	Assessment via a Visual Analogue Scale (VAS), where "0" indicates no nausea and "10" indicates the most severe nausea	Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively
Pruritus Severity	Assessment via a Visual Analogue Scale (VAS), where "0" indicates no pruritus and "10" indicates the worst possible itching	Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively
Postoperative length of hospital stay (days)	Duration from hospital admission to hospital discharge, reported in days.	From hospital admission to hospital discharge (assessed at hospital discharge).
Sedation and agitation level measured by the Richmond Agitation-Sedation Scale (RASS, -5 to +4)	Sedation/agitation is assessed using the Richmond Agitation-Sedation Scale (RASS), ranging from -5 to +4, where: 5 = unarousable,; 4 = deep sedation,; 3 = moderate sedation,; 2 = light sedation,; 1 = drowsy, 0 = alert and calm,1 = restless,2 = agitated,3 = very agitated,4 = combative. Higher scores indicate greater agitation; lower scores indicate deeper sedation. For postoperative recovery, scores closer to 0 are considered more favorable, while scores further from 0 indicate a less favorable state.	At 0, 4, 8, 12, and 24 hours after surgery.
Motor blockade measured by the Bromage motor blockade scale (Grade 0-3)	Motor blockade is assessed using the Bromage motor blockade scale from Grade 0 to Grade 3, where: Grade 0 = no motor blockade (full movement at knee and ankle joints), Grade 1 = partial block (limited/simple knee movement, full foot movement), Grade 2 = almost complete block (no knee movement, preserved foot movement), Grade 3 = complete block (no movement of lower limbs, including knees and feet). Higher grades indicate greater motor blockade (worse motor function). Lower grades indicate less motor blockade (better motor function recovery).	At 0, 4, 8, 12, and 24 hours after surgery.
Sensory blockade	Evaluation of the spinal anesthesia level based on thermal sensation (using an antiseptic spray)	At 0, 4, 8, 12, and 24 hours postoperatively.
Antiemetic Consumption	Total dose of ondansetron and/or other antiemetics administered.	Within the first 24 hours following the completion of surgery
Intraoperative blood loss (mL)	Estimated blood loss during surgery, reported in milliliters (mL).	Intraoperatively (from skin incision to skin closure).
Duration of surgery (minutes)	Time from skin incision to skin closure, reported in minutes.	Intraoperatively (from skin incision to skin closure).
Participants requiring intraoperative vasopressors	Number of participants who required at least one vasopressor dose during surgery, reported as count.	Intraoperatively (from skin incision to skin closure).
Heart rate (beats per minute)	Heart rate measured by bedside monitoring and reported in beats per minute (bpm).	Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.
Peripheral oxygen saturation (SpO2, %)	Peripheral oxygen saturation measured by pulse oximetry and reported as percent (%).	Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.
Diastolic blood pressure (DBP, mmHg)	Non-invasive diastolic blood pressure measured with an automated cuff and reported in mmHg.	Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.
Mean arterial pressure (MAP, mmHg)	Mean arterial pressure reported in mmHg at each assessment time point (device-reported value or calculated from SBP and DBP, per site standard).	Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.
Time to first mobilization (hours)	Time interval from administration of spinal anesthesia to first mobilization, defined as first upright positioning and/or ambulation, reported in hours.	From administration of spinal anesthesia until hospital discharge (time to first mobilization assessed at first mobilization, through study completion an average of 24 hours postoperatively).
Number of participants with predefined anesthesia-related complications	Number of participants with at least one predefined anesthesia-related complication, including accidental vascular puncture, local anesthetic systemic toxicity (LAST), and respiratory failure. Reported as count.	From hospital admission to hospital discharge (assessed daily during hospitalization and at discharge, through study completion an average 5 days postoperatively).
Number of participants with predefined hospitalization-related complications	Number of participants with at least one predefined hospitalization-related complication, including requirement for blood product transfusion, pneumonia, cardiovascular events, and surgical site infection (SSI). Reported as count.	From hospital admission to hospital discharge (assessed daily during hospitalization and at discharge, through study completion an average 5 days postoperatively).

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Study Chair: Radosław Owczuk, MD, PhD, Prof., Medical Unitersity of Gdansk

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Total Hip Arthroplasty; Opioid Consumption; Spinal Anesthesia; Postoperative Analgesia; Pericapsular Nerve Group Block; Intrathecal Morphine; Patient-Controlled Analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anesthesia and Analgesia; Central Nervous System Agents; Anesthesia, Conduction; Anesthesia; Analgesics, Opioid; Anesthesia, Spinal
• Other Study ID Numbers: GRU/KAZ/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No