Enhanced Recovery After Urologic Surgery

NANot yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

May 1, 2025

Study Completion Date

May 20, 2025

Conditions
CircumcisionHydrocelectomyHerniaRenal CystProstate
Interventions
DEVICE

General Anesthesia (GA)

"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%."

PROCEDURE

Epidural Analgesia( 0.2% ropivacaine)

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.

DEVICE

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

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 Once the needle tip contacts the transverse process, it will be withdrawn 1-2 mm, and then slightly angled caudally to pass through the paravertebral ligament and enter the paravertebral space.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

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

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.

PROCEDURE

Intrathecal Morphine

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.

DRUG

Intravenous Patient-Controlled Analgesia (PCA) (fentanyl)

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.

Trial Locations (1)

014010

Inner Mongolia Baogang Hospital, Baotou

All Listed Sponsors
lead

Xiaguang Duan

OTHER

NCT06789744 - Enhanced Recovery After Urologic Surgery | Biotech Hunter | Biotech Hunter