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

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 Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Multimodal analgesia; Procedure: PCIA analgesia

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.

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Jinling Hospital, Medical School of Nanjing University
      • Contact: Zhi-Wei JIANG, Ph.D.; Phone Number: 8602580860034; Email: surgery34@163.com
    • Nanjing, Jiangsu, China, 210011
      • Not yet recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
      • Contact: Qinghong ZHAO, Ph.D.; Email: njzhqh@sina.com
      • Principal Investigator: Baolin WANG, Ph.D.
      • Principal Investigator: Qinghong ZHAO, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multimodal analgesia; Patients received multimodal analgesia after laparoscopic gastrectomy .	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.
Active Comparator: PCIA analgesia; Patients received PCIA analgesia after laparoscopic gastrectomy.	Procedure: PCIA analgesia; PCIA analgesia:patient-controlled intravenous analgesia with tramadol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scales (NRS) score with 24 hours after the surgery	pain evaluation	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: JIANG Zhi-Wei
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): August 30, 2018

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: gastric cancer; gastrectomy; multimodal analgesia; parecoxib
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2016HR1116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No