Hip Disease, Hip Replacement, Total, Perioperative Analgesia, Postoperative Pain
Conditions
Keywords
Pericapsular Nerve Group Block, Intrathecal Morphine, Spinal Anesthesia, Total Hip Arthroplasty, Postoperative Pain, Postoperative Analgesia, Opioid Consumption, Patient-Controlled Analgesia
Brief summary
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.
Interventions
PROCEDUREPNEG 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).
PROCEDURESpinal 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).
PROCEDURESpinal anesthesia without opioid
Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine (Marcaine Spinal 0.5% Heavy, Aspen Pharma, Ireland).
PROCEDURESham 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).
Sponsors
Medical University of Gdansk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative oxycodone consumption delivered via patient-controlled analgesia (PCA) | 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. |
| Number of patient-initiated PCA demand attempts recorded by the PCA pump | 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. |
| Pain intensity at rest measured by the 11-point Numerical Rating Scale (NRS, 0-10) | 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. |
| Dynamic pain assesmnetDynamic pain intensity during passive straight leg raise measured by the 11-point Numerical Rating Scale (NRS, 0-10) | 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. |
| Patient satisfaction with postoperative analgesia measured by a 5-point Likert satisfaction scale (1-5) | At 0, 4, 8, 12, and 24 hours after surgery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea severity | 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 |
| Pruritus Severity | 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 |
| Postoperative length of hospital stay (days) | From hospital admission to hospital discharge (assessed at hospital discharge). | Duration from hospital admission to hospital discharge, reported in days. |
| Sedation and agitation level measured by the Richmond Agitation-Sedation Scale (RASS, -5 to +4) | 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: * 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. |
| Motor blockade measured by the Bromage motor blockade scale (Grade 0-3) | 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). |
| Sensory blockade | At 0, 4, 8, 12, and 24 hours postoperatively. | Evaluation of the spinal anesthesia level based on thermal sensation (using an antiseptic spray) |
| Antiemetic Consumption | Within the first 24 hours following the completion of surgery | Total dose of ondansetron and/or other antiemetics administered. |
| Intraoperative blood loss (mL) | Intraoperatively (from skin incision to skin closure). | Estimated blood loss during surgery, reported in milliliters (mL). |
| Duration of surgery (minutes) | Intraoperatively (from skin incision to skin closure). | Time from skin incision to skin closure, reported in minutes. |
| Participants requiring intraoperative vasopressors | Intraoperatively (from skin incision to skin closure). | Number of participants who required at least one vasopressor dose during surgery, reported as count. |
| Heart rate (beats per minute) | 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). |
| Peripheral oxygen saturation (SpO2, %) | 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 (%). |
| Diastolic blood pressure (DBP, mmHg) | 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. |
| Mean arterial pressure (MAP, mmHg) | 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 to first mobilization (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). | Time interval from administration of spinal anesthesia to first mobilization, defined as first upright positioning and/or ambulation, reported in hours. |
| Number of participants with predefined anesthesia-related complications | 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. |
| Number of participants with predefined hospitalization-related complications | 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. |
Contacts
CONTACTMykhailo Kazantsev, MD
STUDY_CHAIRRadosław Owczuk, MD, PhD, Prof.
Medical Unitersity of Gdansk
Outcome results
None listed