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Enhanced Recovery After Urologic Surgery

ConditionsCircumcisionHydrocelectomyHerniaRenal CystProstate
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorXiaguang Duan

About this trial

This clinical trial aims to investigate the analgesic efficacy of several perioperative pain management strategies-specifically, epidural analgesia, paravertebral blockade, transversus abdominis plane (TAP) block, intravenous patient-controlled analgesia (PCA), and intrathecal morphine-in patients undergoing a range of urological procedures. These procedures include pediatric circumcision, hydrocelectomy, inguinal hernia repair, renal cyst excision, and transurethral resection of the prostate. The trial will also evaluate the safety profiles of two specific local anesthetics, liposomal bupivacaine and ropivacaine. The primary research question is whether these different analgesic techniques reduce postoperative opioid requirements in patients undergoing urological surgery. A secondary question explores the adverse events associated with the use of liposomal bupivacaine and ropivacaine in this population.

Participants will be:

Urological surgery patients undergoing one of the aforementioned procedures. These participants will be randomized to receive one of the following pain management modalities: epidural analgesia, paravertebral blockade, TAP block, intravenous PCA, or intrathecal morphine. Patient assessments will be conducted in the post-anesthesia care unit (PACU) and at 2, 6, 12, and 24 hours postoperatively. Outcome measures will include: Numeric Rating Scale (NRS) pain scores, total postoperative analgesic consumption, recovery status, patient satisfaction, and time to return of bowel function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

any age.

American Society of Anesthesiologists (ASA) physical status classification of I-III.

undergo urological surgery.

receive one of the following analgesic techniques: epidural analgesia (EA), paravertebral block (PVB), transversus abdominis plane (TAP) block, intravenous patient-controlled analgesia (PCA), or intrathecal morphine.

Disqualifiers

a bleeding disorder or coagulopathy.

infection at the intended puncture site or systemic infection.

a known allergy to local anesthetics.

spinal deformity or spinal injury.

Trial design

Design model

Parallel

Treatments tested in this trial

  • General Anesthesia (GA)

    Device

    Patients will be induced with general anesthesia, consisting of propofol (1.5-2 mg/kg intravenously), rocuronium (1-2 mg/kg intravenously), and fentanyl (1-2 μg/kg intravenously). Anesthesia will be maintained with inhaled sevoflurane or desflurane, adjusted according to BIS values. Remifentanil (0.05-0.2 μg/kg/min) will be administered via continuous infusion, with the infusion rate adjusted to maintain blood pressure and heart rate within ±20% of baseline. Following induction, patients will be mechanically ventilated in pressure-regulated volume control (PRVC) mode using an Aestiva anesthesia machine (GE Healthcare, Waukesha, Wisconsin, USA). Ventilator settings will be as follows: tidal volume 6-8 mL/kg, positive end-expiratory pressure 0 cmH2O, inspiratory-to-expiratory ratio 1:2, respiratory rate 16 breaths per minute (BPM), and inspired oxygen concentration of 41%.

  • Epidural Analgesia( 0.2% ropivacaine)

    Procedure/Surgery

    For epidural analgesia, an initial bolus of 5-15 mL of 0.5% ropivacaine will be administered, followed by a continuous infusion of 0.2% ropivacaine at a rate of 3-10 mL/hour. In pediatric patients, the initial bolus will consist of 0.2% ropivacaine at a dose of 0.5-1 mg/kg, not to exceed 2-2.5 mg/kg, followed by a continuous infusion of 0.1-0.3 mg/kg/hour.

  • Paravertebral block ( liposomal bupivacaine 133 mg or 0.2% ropivacaine)

    Device

    For paravertebral blocks, patients will be positioned either sitting or in the lateral decubitus position to fully expose the target area of the spine. The spinous process of the target vertebra will be palpated, and the puncture site identified. Using ultrasound guidance, the paravertebral space will be located. After standard skin preparation, a blunt needle will be advanced perpendicular to the skin. Once the needle tip contacts the transverse process, it will be withdrawn 1-2 mm, and then slightly angled caudally to pass through the paravertebral ligament and enter the paravertebral space. After negative aspiration for blood or cerebrospinal fluid, a 5 mL test dose of local anesthetic will be slowly injected, and the patient observed for adverse effects. If none are noted, an additional 5 mL of local anesthetic will be injected. The local anesthetic solution will be either liposomal bupivacaine (266 mg diluted to 20 mL) or 0.2% ropivacaine.

  • Transversus Abdominis Plane Block (TAP Block)( liposomal bupivacaine 133 mg or 0.2% ropivacaine)

    Device

    For TAP blocks, patients will be positioned supine with the abdomen exposed. Following standard skin preparation, a needle will be advanced perpendicular to the skin using ultrasound guidance, through the external oblique and internal oblique muscles to reach the fascial plane between the transversus abdominis and internal oblique muscles. After negative aspiration for blood, a 5 mL test dose of local anesthetic will be slowly injected, and the patient observed for adverse effects. If none are noted, an additional 10 mL of local anesthetic will be injected. The local anesthetic solution will be either liposomal bupivacaine (266 mg diluted to 20 mL) or 0.2% ropivacaine.

  • Intrathecal Morphine

    Procedure/Surgery

    For intrathecal analgesia, adults will receive 0.1-0.2 mg of morphine intrathecally. For pediatric patients, the dose of intrathecal morphine will be 5-10 mcg/kg.

  • Intravenous Patient-Controlled Analgesia (PCA) (fentanyl)

    Drug

    For intravenous PCA, a solution of fentanyl 2 mcg/kg will be diluted to a total volume of 100 mL with normal saline. The PCA settings will be as follows: a basal rate of 2 mL/hour, a PCA dose of 2 mL, and a lockout interval of 15 minutes.

Treatment groups

150 Participants
are divided into 5 treatment groups
Group A: EA groupExperimental treatment 1 intervention
Group B: PVB groupExperimental treatment 2 interventions
Group C: TAP groupExperimental treatment 2 interventions
Group D: IM groupExperimental treatment 2 interventions
Group E: PCA groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Numerical Rating Scale(NRS)

The NRS, Numerical Rating Scale, is a rating system from 0 to 10, where 0 represents "no pain" and 10 represents the worst possible pain.

Time frame
At baseline (before therapy), at 2 hours post-treatment, at 6 hours post-treatment, at 12 hours post-treatment, and at 24 hours post-treatment.

Secondary outcomes

1

Total Analgesic Consumption

Total consumption of analgesics (opioids and non-opioids) will be recorded in milligrams or milliliters (or equivalent doses) during the study period. This includes:Intravenous analgesics (e.g., fentanyl in PCA), Oral analgesics (e.g., acetaminophen, ibuprofen), Rescue analgesics administered as needed.

Time frame
From surgery to 24 hours post-surgery (cumulative consumption). Hourly consumption will be recorded for the first 24 hours to assess temporal patterns of analgesic use.
2

Patient Satisfaction Score

Patient satisfaction will be evaluated using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Patients will be asked to rate their overall satisfaction with the pain management they received.

Time frame
At 24 hours post-surgery.
3

Time to First Flatus or Bowel Movement

Time in hours from the end of surgery to the first passage of flatus or bowel movement, indicating the return of bowel function.

Time frame
From the end of surgery up to 24 hours.
4

Occurrence of Adverse Events

Record all adverse events related to the interventions, including but not limited to: Nausea and vomiting, Pruritus (itching), Urinary retention, Respiratory depression, Local anesthetic toxicity (e.g., seizures, cardiac dysrhythmias), Hematoma at the injection site, Infection.

Time frame
At 24 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiaguang Duan

Lead sponsor

Inner Mongolia Baogang Hospital

Sponsor institution

Source ClinicalTrials.gov

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