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

NCT06772545 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-14

No results posted yet for this study

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

Interventions

PROCEDURE

Epidural Analgesia

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

Paravertebral Block

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.

DEVICE

Transversus Abdominis Plane Block

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.

DEVICE

patient-controlled intravenous analgesia (PCA)

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.

Sponsors & Collaborators

  • Xiaguang Duan

    lead OTHER

Principal Investigators

  • Xiangyu Wang, MM · Inner Mongolia Baogang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-05-01
Completion
2025-05-10
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06772545 on ClinicalTrials.gov