The Impact of Intrathecal Morphine Versus Continuous Epidural Analgesia on Return of Bowel Function in Patients Undergoing Laparoscopic Ileal Conduit

NCT06688643 | Completed DMC FDA Device

• 1 other identifier: 2021-MER-206
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effects of intrathecal morphine (ITM) and continuous epidural analgesia (CEA) on bowel function recovery after Bricker surgery.This study was a prospective, randomized controlled trial that included 72 patients with bladder cancer undergoing elective Bricker surgery, who were randomly assigned to either the ITM group (n=36) or the CEA group (n=36). Postoperatively, patients in both groups received either ITM or CEA for pain management, and postoperative bowel function recovery time, pain scores, PONV, itching, and other indicators were recorded.

Conditions

Bladder Cancer

Keywords

Bowel function; Continuous epidural analgesia (CEA); intrathecal morphine(ITM); laparoscopic ileal conduit (Bricker); Postoperative nausea and vomiting(PONV); Pruritus

Outcome Measures

Primary Outcomes (1)

• bowel function recovery time

  12 hours indicates good bowel function, 24 hours indicates good bowel function.

  24 hours after surgery

Secondary Outcomes (1)

• pain scores

  24 hours after surgery

Study Arms (2)

ITM group

EXPERIMENTAL

Patients in the ITM group underwent intrathecal injection with 0.2 mg morphine after admission to the operating room.

Device: ITM group

EA group

EXPERIMENTAL

Patients in the EA group underwent epidural anesthesia after admission to the operating room. Following successful epidural puncture, 3 ml of 2% lidocaine was administered. Once the block level was confirmed, the epidural analgesia pump was activated, delivering 8 ml/h of 0.1% ropivacaine.

Device: EA group

Interventions

ITM group DEVICE

Patients in the ITM group underwent intrathecal injection with 0.2 mg morphine after admission to the operating room.Mechanical ventilation was initiated in pressure-regulated volume control (PRVC) mode after induction. Ventilator settings (Aestiva; GE Healthcare, Waukesha, Wisconsin, USA) were as follows: tidal volume 6-8 ml kg-1, positive end-expiratory pressure (PEEP) 0 cmH2O, inspiratory-to-expiratory ratio 1:2, respiratory rate 16 beats per minute (BPM), and inspired oxygen concentration 41%.

ITM group

EA group DEVICE

Patients in the EA group underwent epidural anesthesia after admission to the operating room. Following successful epidural puncture, 3 ml of 2% lidocaine was administered. Once the block level was confirmed, the epidural analgesia pump was activated, delivering 8 ml/h of 0.1% ropivacaine.Mechanical ventilation was initiated in pressure-regulated volume control (PRVC) mode after induction. Ventilator settings (Aestiva; GE Healthcare, Waukesha, Wisconsin, USA) were as follows: tidal volume 6-8 ml kg-1, positive end-expiratory pressure (PEEP) 0 cmH2O, inspiratory-to-expiratory ratio 1:2, respiratory rate 16 beats per minute (BPM), and inspired oxygen concentration 41%.

EA group

Eligibility Criteria

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

You may qualify if:

• All participants provided informed consent voluntarily
• ASA I-III

You may not qualify if:

• allergies to any anesthetic agents used in this study
• refused to sign the consent form
• uncooperative were deemed ineligible for clinical evaluation
• hypersensitivity to pain
• a history of gastrointestinal disease
• sleep disorders

Sponsors & Collaborators

• Xiaguang Duan: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Postoperative Nausea and Vomiting; Pruritus

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, 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: November 11, 2024
• First Posted: November 14, 2024
• Study Start: January 25, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 14, 2024

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: January 2025-January 2026
• Access Criteria: Anyone needing IPD information, contact the author at email: alonlord2023@gmail.com

Locations

CN (1)