Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study

Overview

The study is aimed to explore the effects of multimodal analgesia consisting of ropivacaine's wound infiltration, parecoxib's intravenous injection and oxycodone-acetaminophen tablets' oral administration on postoperative pain and rehabilitation after laparoscopic radical gastrectomy for patients with gastric cancer.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2018

Detailed Description

Postoperative pain attracts the attention of surgeons, and optimal postoperative pain management contributes to reducing complications and accelerating postoperative rehabilitation. Traditionally, the opioids were used for postoperative pain control. However, the opioids may increase the time to recover bowel function and lead to postoperative ileus. Multimodal analgesia is recommended in recent years, but studies on multimodal analgesia after gastrectomy are scarce. In this study, we introduced a multimodal analgesia strategy consisting of incision infiltration with ropivacaine, intravenous injection of parecoxib, and oral administration of an oxycodone/paracetamol mixture and evaluated the effects of this strategy compared with PCIA analgesia which is used widely for pain after gastrectomy.

Interventions

  • Procedure: Multimodal analgesia
    • Multimodal analgesia is the name of a procedure or program. Multimodal analgesia doesn’t mean different interventions are used. Patients in this group need receive this analgesia program (procedure) instead of one analgesic drug or technology. The program consists of incision infiltration with ropivacaine, intravenous injection of parecoxib, and oral administration of oxycodone/paracetamol mixture.
  • Procedure: PCIA analgesia
    • PCIA analgesia:patient-controlled intravenous analgesia with tramadol.

Arms, Groups and Cohorts

  • Experimental: multimodal analgesia
    • Patients received multimodal analgesia after laparoscopic gastrectomy .
  • Active Comparator: PCIA analgesia
    • Patients received PCIA analgesia after laparoscopic gastrectomy.

Clinical Trial Outcome Measures

Primary Measures

  • Numeric rating scales (NRS) score with 24 hours after the surgery
    • Time Frame: 1 day
    • pain evaluation

Secondary Measures

  • NRS score after 24 hours postoperatively
    • Time Frame: 1 week
    • pain evaluation
  • Number of remedial treatment
    • Time Frame: 1 week
    • pain evaluation
  • Time to first flatus
    • Time Frame: 1 week
    • Bowel function recovery
  • Time to first off-bed activity
    • Time Frame: 1 week
    • Postoperative activity
  • Time of off-bed activity per day
    • Time Frame: 1 week
    • Postoperative activity
  • Length of off-bed activity per day
    • Time Frame: 1 week
    • Postoperative activity
  • Time to first semi-liquid diet
    • Time Frame: 1 week
    • Bowel function recovery
  • Postoperative length of stay
    • Time Frame: 1 month
    • postoperative length of stay
  • C-reactive protein (CRP)
    • Time Frame: 1 week
    • Inflammatory indicators
  • interleukin-6 (IL-6)
    • Time Frame: 1 week
    • Inflammatory indicators
  • Albumin
    • Time Frame: 1 year
    • Nutritional status
  • Total protein
    • Time Frame: 1 year
    • Nutritional status
  • Prealbumin
    • Time Frame: 1 year
    • Nutritional status

Participating in This Clinical Trial

Inclusion Criteria

1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable. 2. Patients underwent laparoscopic radical gastrectomy under general anesthesia and between the age of 18 and 75 years old without considering sex. 3. American Society of Anesthesiologists (ASA) physical status I-III. 4. Participants can follow the drug doses and visit plan Exclusion Criteria:

1. Patients certified by a doctor that doesn't fit to participate in this study. 2. Patients allergic to opioids, sulfas, parecoxib, non-steroidal drugs, acetaminophen, tramadol etc.. 3. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg). 4. Patients with gastric cancer with distant metastasis. 5. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child – Pugh≥ 10; creatinine clearance < 25 ml/min). 6. Patients with suspect or have a history of drug abuse. 7. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants). 8. Sponsors or researchers directly involved in the testing or their family members. 9. Patients with conversion, palliative resection. 10. Patients with chronic pain(NRS≥3)or using opioids or NSAIDs before surgery.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • JIANG Zhi-Wei
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: JIANG Zhi-Wei, Vice director of Research Institute of General Surgery – Jinling Hospital, China
  • Overall Official(s)
    • Zhi-Wei JIANG, Ph.D., Principal Investigator, Jinling Hospital, Medical School of Nanjing University
    • Jian ZHAO, Ph.D., Study Director, Jinling Hospital, Medical School of Nanjing University
    • Gang WANG, Ph.D., Study Director, Jinling Hospital, Medical School of Nanjing University
    • Jiang LIU, M.D., Study Director, Jinling Hospital, Medical School of Nanjing University
  • Overall Contact(s)
    • Zhi-Wei JIANG, Ph.D., 8602580860034, surgery34@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.