An interventional study of PNEG block and Spinal anesthesia with opioid in Perioperative Analgesia, Hip Replacement, Total and Postoperative Pain, sponsored by Medical University of Gdansk. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Treatment
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
5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's planned enrollment of 180 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Medical University of Gdansk is the lead sponsor of 130 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Spinal anesthesia without opioid + PENG block
Procedure: PNEG block · Procedure: Spinal anesthesia without opioid
Spinal anesthesia with opioid and sham PENG Block
Procedure: Spinal anesthesia with opioid · Procedure: Sham PENG block
Spinal anesthesia without opioid and sham PENG Block
Procedure: Spinal anesthesia without opioid · Procedure: Sham PENG 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).
Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine, supplemented with 100 mcg of morphine (Morphini Sulfas WZF 0.1% Spinal, Polpharma, Poland).
Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine (Marcaine Spinal 0.5% Heavy, Aspen Pharma, Ireland).
A sham PENG block will be performed using 20 mL of 0.9% sodium chloride solution (Natrium chloratum 0,9% Fresenius, Fresenius Kabi, Poland).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: 1. = definitely dissatisfied, 2. = dissatisfied, 3. = neither satisfied nor dissatisfied (neutral), 4. = satisfied, 5. = definitely satisfied. Higher scores indicate greater satisfaction.
Time frame: At 0, 4, 8, 12, and 24 hours after surgery.
Nausea severity
Assessment via a Visual Analogue Scale (VAS), where "0" indicates no nausea and "10" indicates the most severe nausea
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: At 0, 4, 8, 12, and 24 hours postoperatively.
Antiemetic Consumption
Total dose of ondansetron and/or other antiemetics administered.
Time frame: Within the first 24 hours following the completion of surgery
Intraoperative blood loss (mL)
Estimated blood loss during surgery, reported in milliliters (mL).
Time frame: Intraoperatively (from skin incision to skin closure).
Duration of surgery (minutes)
Time from skin incision to skin closure, reported in minutes.
Time frame: 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.
Time frame: 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).
Time frame: 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 (%).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From hospital admission to hospital discharge (assessed daily during hospitalization and at discharge, through study completion an average 5 days postoperatively).
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Plan to share: No
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Medical University of Gdansk