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Not yet recruiting NCT07449585

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

No phase Interventional Perioperative Analgesia Hip Replacement, Total Postoperative Pain Hip Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PNEG block, Spinal anesthesia with opioid, Spinal anesthesia without opioid, Sham PENG block.
Who it may be relevant to
Registry conditions: Perioperative Analgesia, Hip Replacement, Total, Postoperative Pain, Hip Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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 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 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).

Primary outcome measures

  • Cumulative oxycodone consumption delivered via patient-controlled analgesia (PCA) [Time frame: From end of surgery to 24 hours postoperatively.]
  • Number of patient-initiated PCA demand attempts recorded by the PCA pump [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) [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) [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) [Time frame: At 0, 4, 8, 12, and 24 hours after surgery.]
Secondary outcome measures (12)
  • Nausea severity [Time frame: Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively]
  • Pruritus Severity [Time frame: Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively]
  • Postoperative length of hospital stay (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) [Time frame: At 0, 4, 8, 12, and 24 hours after surgery.]
  • Motor blockade measured by the Bromage motor blockade scale (Grade 0-3) [Time frame: At 0, 4, 8, 12, and 24 hours after surgery.]
  • Sensory blockade [Time frame: At 0, 4, 8, 12, and 24 hours postoperatively.]
  • Antiemetic Consumption [Time frame: Within the first 24 hours following the completion of surgery]
  • Intraoperative blood loss (mL) [Time frame: Intraoperatively (from skin incision to skin closure).]
  • Duration of surgery (minutes) [Time frame: Intraoperatively (from skin incision to skin closure).]
  • Participants requiring intraoperative vasopressors [Time frame: Intraoperatively (from skin incision to skin closure).]
  • Heart rate (beats per minute) [Time frame: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.]
  • Peripheral oxygen saturation (SpO2, %) [Time frame: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07449585 · GRU/KAZ/1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗