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Status unknownNCT03236051Updated Aug 1, 2017

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

An interventional study of Multimodal analgesia and PCIA analgesia in Gastric Cancer, sponsored by JIANG Zhi-Wei. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by JIANG Zhi-Wei · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Feb 2017, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastric Cancer

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Keywords

  • gastric cancer
  • gastrectomy
  • multimodal analgesia
  • parecoxib
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 156 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

JIANG Zhi-Wei is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
156 participants (estimated)

Study arms

  • Experimental
    multimodal analgesia

    Patients received multimodal analgesia after laparoscopic gastrectomy .

    Procedure: Multimodal analgesia

  • Active comparator
    PCIA analgesia

    Patients received PCIA analgesia after laparoscopic gastrectomy.

    Procedure: PCIA analgesia

Interventions

  • ProcedureMultimodal 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.

  • ProcedurePCIA analgesia

    PCIA analgesia:patient-controlled intravenous analgesia with tramadol.

06

What researchers measure

Primary outcomes

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

    pain evaluation

    Time frame: 1 day

Secondary outcomes

  1. NRS score after 24 hours postoperatively

    pain evaluation

    Time frame: 1 week

  2. Number of remedial treatment

    pain evaluation

    Time frame: 1 week

  3. Time to first flatus

    Bowel function recovery

    Time frame: 1 week

  4. Time to first off-bed activity

    Postoperative activity

    Time frame: 1 week

  5. Time of off-bed activity per day

    Postoperative activity

    Time frame: 1 week

  6. Length of off-bed activity per day

    Postoperative activity

    Time frame: 1 week

  7. Time to first semi-liquid diet

    Bowel function recovery

    Time frame: 1 week

  8. Postoperative length of stay

    postoperative length of stay

    Time frame: 1 month

  9. C-reactive protein (CRP)

    Inflammatory indicators

    Time frame: 1 week

  10. interleukin-6 (IL-6)

    Inflammatory indicators

    Time frame: 1 week

  11. Albumin

    Nutritional status

    Time frame: 1 year

  12. Total protein

    Nutritional status

    Time frame: 1 year

  13. Prealbumin

    Nutritional status

    Time frame: 1 year

07

Study locations

1 of 2 sites recruiting
  • Jinling Hospital, Medical School of Nanjing University
    Nanjing, Jiangsu 210002, China
    • Zhi-Wei JIANG, Ph.D. · Contact · surgery34@163.com · 8602580860034
    • Jian ZHAO, Ph.D. · Contact · zhaojiangogo@163.com · 8602580860034
    • Zhi-Wei JIANG, Ph.D. · Principal investigator
    • Jian ZHAO, Ph.D. · Sub investigator
    • Gang WANG, Ph.D. · Sub investigator
    • Jiang LIU, M.D. · Sub investigator
    Recruiting
  • The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210011, China
    • Qinghong ZHAO, Ph.D. · Contact · njzhqh@sina.com
    • Baolin WANG, Ph.D. · Principal investigator
    • Qinghong ZHAO, Ph.D. · Principal investigator
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03236051
Lead sponsor
JIANG Zhi-Wei
Collaborators
Pfizer
Responsible party
JIANG Zhi-Wei (Vice director of Research Institute of General Surgery, Jinling Hospital, China) — Sponsor-investigator
First posted
Aug 1, 2017
Start date
Feb 10, 2017
Primary completion
Jun 30, 2018 (estimated)
Completion
Aug 30, 2018 (estimated)
Last update
Aug 1, 2017

Study contacts

Zhi-Wei JIANG, Ph.D.
Contact
surgery34@163.com
8602580860034
Jian ZHAO, Ph.D.
Contact
zhaojiangogo@163.com
8602580860034
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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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