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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiaguang Duan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Epidural Analgesia

    Procedure/Surgery

    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.

  • 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.

  • 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.

  • 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.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: EAExperimental treatment 1 intervention
Group B: PBExperimental treatment 1 intervention
Group C: TAPExperimental treatment 1 intervention
Group D: PCIAActive comparator 1 intervention

Trial outcomes

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.

Time frame
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)

A participant was considered to have achieved a response if their performance status score was either 0 or 72 hours, on a scale where 0 represented the best outcome and 72 the worst outcome.

Time frame
At 72 hours post-surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiaguang Duan

Lead sponsor

Inner Mongolia Baogang Hospital

Sponsor institution

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