Study on the Effects of Multimodal Analgesia Regimens on Postoperative Analgesia and Gastrointestinal Function Recovery After Laparoscopic Abdominal Surgery

NCT06772545 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2024-MER-321
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial aims to investigate the impact of multimodal analgesia regimens on postoperative pain management and gastrointestinal function recovery following laparoscopic abdominal surgery. The primary objectives are to determine: Which analgesic regimen is most effective in reducing postoperative pain? Which analgesic regimen is most effective in accelerating gastrointestinal function recovery? This study will compare epidural analgesia (EA), paravertebral block (PB), transversus abdominis plane block (TAP), and patient-controlled intravenous analgesia (PCIA) to identify the optimal method for pain control and the most beneficial for gastrointestinal recovery. Participants will receive one of the following treatments postoperatively: epidural analgesia, paravertebral block, TAP block, or patient-controlled intravenous analgesia. Rest pain (measured using the Numerical Rating Scale, NRS), dynamic pain (NRS), morphine equivalent consumption (mg), quality of sleep on the first night (Likert scale, 1-5), time to return of bowel function (h), time to recommence oral intake (h), time to first mobilization (h), quality of recovery (QoR, 0-15) on postoperative day 1, and length of hospital stay (days) will be recorded at 4, 8, 12, and 24 hours post-procedure.

Conditions

Laparoscopic Abdominal Surgery

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 4 hours post-treatment, 8 hours post-treatment, 12 hours post-treatment, and 24 hours post-treatment

Secondary Outcomes (1)

• Functional recovery Return bowel function(h)

  At 72 hours post-surgery

Study Arms (4)

EA

EXPERIMENTAL

Epidural Analgesia

Procedure: Epidural Analgesia

PB

EXPERIMENTAL

Paravertebral Block

Device: Paravertebral Block

TAP

EXPERIMENTAL

Transversus Abdominis Plane Block

Device: Transversus Abdominis Plane Block

PCIA

ACTIVE COMPARATOR

Patient-Controlled Intravenous Analgesia

Device: patient-controlled intravenous analgesia (PCA)

Interventions

Epidural Analgesia PROCEDURE

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.

EA

Paravertebral Block DEVICE

Using an in-plane technique, the puncture needle was advanced from lateral to medial under real-time ultrasound guidance to the target paravertebral space, passing through the intercostal fascia, avoiding the parietal pleura, and positioning the needle tip superior to the costotransverse ligament. After confirming needle tip placement, 10 mL of 0.5% ropivacaine was slowly injected in divided doses, observing for the spread of the local anesthetic to ensure adequate distribution within the PVS for effective block.

PB

Transversus Abdominis Plane Block DEVICE

The plane of blockade and whether to perform a single or double injection technique were determined based on the incision location. Under real-time ultrasound guidance, the puncture needle was advanced to the target transversus abdominis plane. After confirming needle tip placement, 10 mL of 0.5% ropivacaine was injected slowly in a fractionated manner while observing the local anesthetic spread to ensure effective blockade.

TAP

patient-controlled intravenous analgesia (PCA) DEVICE

The patient-controlled analgesia (PCA) device was programmed to deliver bolus doses of 15 μg fentanyl, with a 10-minute lockout period and no background infusion. The PCA solution consisted of 1 mg fentanyl and 8 mg of tropisetron mixed in 100 mL of normal saline.

PCIA

Eligibility Criteria

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

You may qualify if:

• \>18 years old
• ASA I-III
• Ability to understand and voluntarily sign the informed consent form
• No prior use of long-acting or addictive analgesic drugs before surgery.

You may not qualify if:

• History of previous abdominal surgery
• Presence of severe cardiovascular, respiratory, hepatic, renal, neurological, or psychiatric disorders
• Pre-existing chronic pain conditions
• Known allergy to any analgesic drugs used in this study
• Presence of spinal deformities, neurological conditions, or coagulopathy that may affect the performance of regional anesthesia.
• Pregnant or breastfeeding women
• Inability to cooperate with study procedures or understand pain rating scales
• History of opioid abuse or addiction.

Sponsors & Collaborators

• Xiaguang Duan: lead

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Xiangyu Wang, MM

  Inner Mongolia Baogang Hospital

  PRINCIPAL INVESTIGATOR

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 10, 2025
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 10, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2026-January 2036
• Access Criteria: A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.