PNEG block
ProcedurePericapsular 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).
NCT Number: NCT07449585
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: From end of surgery to 24 hours postoperatively.
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.
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: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.
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.
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: At 0, 4, 8, 12, and 24 hours after surgery.
Patient-reported satisfaction with postoperative analgesia assessed using a 5-point Likert satisfaction scale:
Time frame: Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively
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
Assessment via a Visual Analogue Scale (VAS), where "0" indicates no pruritus and "10" indicates the worst possible itching
Time frame: From hospital admission to hospital discharge (assessed at hospital discharge).
Duration from hospital admission to hospital discharge, reported in days.
Time frame: At 0, 4, 8, 12, and 24 hours after surgery.
Sedation/agitation is assessed using the Richmond Agitation-Sedation Scale (RASS), ranging from -5 to +4, where:
Time frame: At 0, 4, 8, 12, and 24 hours after surgery.
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 postoperatively.
Evaluation of the spinal anesthesia level based on thermal sensation (using an antiseptic spray)
Time frame: Within the first 24 hours following the completion of surgery
Total dose of ondansetron and/or other antiemetics administered.
Time frame: Intraoperatively (from skin incision to skin closure).
Estimated blood loss during surgery, reported in milliliters (mL).
Time frame: Intraoperatively (from skin incision to skin closure).
Time from skin incision to skin closure, reported in minutes.
Time frame: Intraoperatively (from skin incision to skin closure).
Number of participants who required at least one vasopressor dose during surgery, reported as count.
Time frame: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.
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 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.
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 reported in mmHg at each assessment time point (device-reported value or calculated from SBP and DBP, per site standard).
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).
Time interval from administration of spinal anesthesia to first mobilization, defined as first upright positioning and/or ambulation, reported in hours.
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 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 at least one predefined hospitalization-related complication, including requirement for blood product transfusion, pneumonia, cardiovascular events, and surgical site infection (SSI). Reported as count.
Contact information is provided by the study sponsor or research team.
Medical University of Gdansk
Other
Comparison of the Efficacy of the Pericapsular Nerve Group (PENG) Block Versus Intrathecal Morphine for Postoperative Analgesia Following Total Hip Arthroplasty
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