Back to resultsMultimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multimodal analgesia
PCIA analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, gastrectomy, multimodal analgesia, parecoxib
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Jinling Hospital, Medical School of Nanjing UniversityRecruiting
- The Second Affiliated Hospital of Nanjing Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
multimodal analgesia
PCIA analgesia
Arm Description
Patients received multimodal analgesia after laparoscopic gastrectomy .
Patients received PCIA analgesia after laparoscopic gastrectomy.
Outcomes
Primary Outcome Measures
Numeric rating scales (NRS) score with 24 hours after the surgery
pain evaluation
Secondary Outcome Measures
NRS score after 24 hours postoperatively
pain evaluation
Number of remedial treatment
pain evaluation
Time to first flatus
Bowel function recovery
Time to first off-bed activity
Postoperative activity
Time of off-bed activity per day
Postoperative activity
Length of off-bed activity per day
Postoperative activity
Time to first semi-liquid diet
Bowel function recovery
Postoperative length of stay
postoperative length of stay
C-reactive protein (CRP)
Inflammatory indicators
interleukin-6 (IL-6)
Inflammatory indicators
Albumin
Nutritional status
Total protein
Nutritional status
Prealbumin
Nutritional status
Full Information
NCT ID
NCT03236051
First Posted
July 26, 2017
Last Updated
July 27, 2017
Sponsor
JIANG Zhi-Wei
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT03236051
Brief Title
Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study
Official Title
Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
August 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JIANG Zhi-Wei
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, gastrectomy, multimodal analgesia, parecoxib
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, parallel, controlled, open study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
multimodal analgesia
Arm Type
Experimental
Arm Description
Patients received multimodal analgesia after laparoscopic gastrectomy .
Arm Title
PCIA analgesia
Arm Type
Active Comparator
Arm Description
Patients received PCIA analgesia after laparoscopic gastrectomy.
Intervention Type
Procedure
Intervention Name(s)
Multimodal analgesia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PCIA analgesia
Intervention Description
PCIA analgesia:patient-controlled intravenous analgesia with tramadol.
Primary Outcome Measure Information:
Title
Numeric rating scales (NRS) score with 24 hours after the surgery
Description
pain evaluation
Time Frame
1 day
Secondary Outcome Measure Information:
Title
NRS score after 24 hours postoperatively
Description
pain evaluation
Time Frame
1 week
Title
Number of remedial treatment
Description
pain evaluation
Time Frame
1 week
Title
Time to first flatus
Description
Bowel function recovery
Time Frame
1 week
Title
Time to first off-bed activity
Description
Postoperative activity
Time Frame
1 week
Title
Time of off-bed activity per day
Description
Postoperative activity
Time Frame
1 week
Title
Length of off-bed activity per day
Description
Postoperative activity
Time Frame
1 week
Title
Time to first semi-liquid diet
Description
Bowel function recovery
Time Frame
1 week
Title
Postoperative length of stay
Description
postoperative length of stay
Time Frame
1 month
Title
C-reactive protein (CRP)
Description
Inflammatory indicators
Time Frame
1 week
Title
interleukin-6 (IL-6)
Description
Inflammatory indicators
Time Frame
1 week
Title
Albumin
Description
Nutritional status
Time Frame
1 year
Title
Total protein
Description
Nutritional status
Time Frame
1 year
Title
Prealbumin
Description
Nutritional status
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-Wei JIANG, Ph.D.
Phone
8602580860034
Email
surgery34@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian ZHAO, Ph.D.
Phone
8602580860034
Email
zhaojiangogo@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Wei JIANG, Ph.D.
Organizational Affiliation
Jinling Hospital, Medical School of Nanjing University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian ZHAO, Ph.D.
Organizational Affiliation
Jinling Hospital, Medical School of Nanjing University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gang WANG, Ph.D.
Organizational Affiliation
Jinling Hospital, Medical School of Nanjing University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jiang LIU, M.D.
Organizational Affiliation
Jinling Hospital, Medical School of Nanjing University
Official's Role
Study Director
Facility Information:
Facility Name
Jinling Hospital, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Wei JIANG, Ph.D.
Phone
8602580860034
Email
surgery34@163.com
First Name & Middle Initial & Last Name & Degree
Jian ZHAO, Ph.D.
Phone
8602580860034
Email
zhaojiangogo@163.com
First Name & Middle Initial & Last Name & Degree
Zhi-Wei JIANG, Ph.D.
First Name & Middle Initial & Last Name & Degree
Jian ZHAO, Ph.D.
First Name & Middle Initial & Last Name & Degree
Gang WANG, Ph.D.
First Name & Middle Initial & Last Name & Degree
Jiang LIU, M.D.
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinghong ZHAO, Ph.D.
Email
njzhqh@sina.com
First Name & Middle Initial & Last Name & Degree
Baolin WANG, Ph.D.
First Name & Middle Initial & Last Name & Degree
Qinghong ZHAO, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study
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