Enhanced Recovery After Urologic Surgery

NCT06789744 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2024-MER-315
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Circumcision; Hydrocelectomy; Hernia; Renal Cyst; Prostate

Outcome Measures

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.

  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 (4)

• Total Analgesic Consumption

  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.

• Patient Satisfaction Score

  At 24 hours post-surgery.

• Time to First Flatus or Bowel Movement

  From the end of surgery up to 24 hours.

• Occurrence of Adverse Events

  At 24 hours after surgery

Study Arms (5)

EA group

EXPERIMENTAL

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.

Procedure: Epidural Analgesia( 0.2% ropivacaine)

PVB group

EXPERIMENTAL

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.

Device: General Anesthesia (GA); Device: Paravertebral block ( liposomal bupivacaine 133 mg or 0.2% ropivacaine)

TAP group

EXPERIMENTAL

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.

Device: General Anesthesia (GA); Device: Transversus Abdominis Plane Block (TAP Block)( liposomal bupivacaine 133 mg or 0.2% ropivacaine)

IM group

EXPERIMENTAL

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.

Procedure: Epidural Analgesia( 0.2% ropivacaine); Procedure: Intrathecal Morphine

PCA group

ACTIVE COMPARATOR

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.

Device: General Anesthesia (GA); Drug: Intravenous Patient-Controlled Analgesia (PCA) (fentanyl)

Interventions

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%.

PCA group; PVB group; TAP group

Epidural Analgesia( 0.2% ropivacaine) PROCEDURE

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.

EA group; IM group

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.

PVB group

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.

TAP group

Intrathecal Morphine PROCEDURE

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.

IM group

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.

PCA group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• provided voluntary informed consent.

You may not qualify if:

• 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.
• a psychiatric disorder that could impair their ability to cooperate with the study protocol.
• pregnant or breastfeeding.
• severe cardiovascular or pulmonary dysfunction.
• chronic opioid use (defined as \>1 month) at high doses.

Sponsors & Collaborators

• Xiaguang Duan: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Conditions

Hernia

Interventions

Anesthesia, General; Analgesia, Epidural; Ropivacaine; Analgesia, Patient-Controlled; Passive Cutaneous Anaphylaxis; Fentanyl

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xiaguang Duan, Master's degree

CONTACT

+86 13314720012; alonlord2023@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Anesthesiology

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 20, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2026-January 2031
• Access Criteria: A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.

Locations

CN (1)