Pericapsular Nerve Group Block Versus Intrathecal Morphine for Analgesia After Total Hip Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Gdansk
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Absence of informed consent.
Age below 18 years.
Psychoactive substance abuse or dependence.
Chronic opioid therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
PNEG block
Procedure/SurgeryPericapsular 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 with opioid
Procedure/SurgerySpinal 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 without opioid
Procedure/SurgerySpinal anesthesia will be administered using 0.5% hyperbaric bupivacaine (Marcaine Spinal 0.5% Heavy, Aspen Pharma, Ireland).
Sham PENG block
Procedure/SurgeryA sham PENG block will be performed using 20 mL of 0.9% sodium chloride solution (Natrium chloratum 0,9% Fresenius, Fresenius Kabi, Poland).
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: PENG GroupExperimental treatment 2 interventions
Group B: MF GroupActive comparator 2 interventions
Group C: ControlSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Secondary outcomes
1
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 postoperatively2
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 postoperatively3
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).4
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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