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

NCT03236051 | Unknown DMC

• 1 other identifier: 2016HR1116
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

gastric cancer; gastrectomy; multimodal analgesia; parecoxib

Outcome Measures

Primary Outcomes (1)

• Numeric rating scales (NRS) score with 24 hours after the surgery

  pain evaluation

  1 day

Secondary Outcomes (13)

• NRS score after 24 hours postoperatively

  1 week

• Number of remedial treatment

  1 week

• Time to first flatus

  1 week

• Time to first off-bed activity

  1 week

• Time of off-bed activity per day

  1 week

Study Arms (2)

multimodal analgesia

EXPERIMENTAL

Patients received multimodal analgesia after laparoscopic gastrectomy .

Procedure: Multimodal analgesia

PCIA analgesia

ACTIVE COMPARATOR

Patients received PCIA analgesia after laparoscopic gastrectomy.

Procedure: PCIA analgesia

Interventions

Multimodal analgesia PROCEDURE

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.

multimodal analgesia

PCIA analgesia PROCEDURE

PCIA analgesia:patient-controlled intravenous analgesia with tramadol.

PCIA analgesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients certified by a doctor that doesn't fit to participate in this study.
• Patients allergic to opioids, sulfas, parecoxib, non-steroidal drugs, acetaminophen, tramadol etc..
• 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).
• Patients with gastric cancer with distant metastasis.
• Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance \< 25 ml/min).
• Patients with suspect or have a history of drug abuse.
• Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
• Sponsors or researchers directly involved in the testing or their family members.
• Patients with conversion, palliative resection.
• Patients with chronic pain（NRS≥3）or using opioids or NSAIDs before surgery.

Sponsors & Collaborators

• JIANG Zhi-Wei: lead
• Pfizer: collaborator

Study Sites (2)

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

NOT YET RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Zhi-Wei JIANG, Ph.D.

  Jinling Hospital, Medical School of Nanjing University

  PRINCIPAL INVESTIGATOR

• Jian ZHAO, Ph.D.

  Jinling Hospital, Medical School of Nanjing University

  STUDY DIRECTOR

• Gang WANG, Ph.D.

  Jinling Hospital, Medical School of Nanjing University

  STUDY DIRECTOR

• Jiang LIU, M.D.

  Jinling Hospital, Medical School of Nanjing University

  STUDY DIRECTOR

Central Study Contacts

Zhi-Wei JIANG, Ph.D.

CONTACT

8602580860034; surgery34@163.com

Jian ZHAO, Ph.D.

CONTACT

8602580860034; zhaojiangogo@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice director of Research Institute of General Surgery

Model Details: This is a randomized, parallel, controlled, open study.

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 1, 2017
• Study Start: February 10, 2017
• Primary Completion: June 30, 2018
• Study Completion: August 30, 2018
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)