Gastric CancerNCT03236051
Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study
A study testing Multimodal analgesia and PCIA analgesia in people with Gastric Cancer, run by JIANG Zhi-Wei at 2 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Multimodal analgesia and PCIA analgesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesChina
- Study dates
- 10 Feb 2017to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Zhi-Wei JIANG, Ph.D., 8602580860034, surgery34@163.com
Jian ZHAO, Ph.D., 8602580860034, zhaojiangogo@163.com
- Not yet recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Qinghong ZHAO, Ph.D., njzhqh@sina.com
Baolin WANG, Ph.D.
About this 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.
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.
- Conditions
- Gastric Cancer
- Being tested
- Multimodal analgesia, PCIA analgesia
- Keywords
- gastric cancer, gastrectomy, multimodal analgesia, parecoxib
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal analgesiaProcedure or surgery
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.
PCIA analgesiaProcedure or surgery
PCIA analgesia:patient-controlled intravenous analgesia with tramadol.
| Study group | Role | What they receive |
|---|---|---|
| multimodal analgesia | Experimental | Patients received multimodal analgesia after laparoscopic gastrectomy . Receives: Procedure: Multimodal analgesia |
| PCIA analgesia | Active comparator | Patients received PCIA analgesia after laparoscopic gastrectomy. Receives: Procedure: PCIA analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scales (NRS) score with 24 hours after the surgery
pain evaluation
Measured: 1 day
Secondary outcomes (13)
NRS score after 24 hours postoperatively
pain evaluation
Measured: 1 week
Number of remedial treatment
pain evaluation
Measured: 1 week
Time to first flatus
Bowel function recovery
Measured: 1 week
Time to first off-bed activity
Postoperative activity
Measured: 1 week
Time of off-bed activity per day
Postoperative activity
Measured: 1 week
Length of off-bed activity per day
Postoperative activity
Measured: 1 week
Time to first semi-liquid diet
Bowel function recovery
Measured: 1 week
Postoperative length of stay
postoperative length of stay
Measured: 1 month
C-reactive protein (CRP)
Inflammatory indicators
Measured: 1 week
interleukin-6 (IL-6)
Inflammatory indicators
Measured: 1 week
Albumin
Nutritional status
Measured: 1 year
Total protein
Nutritional status
Measured: 1 year
Prealbumin
Nutritional status
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start10 Feb 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel, controlled, open study.
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JIANG Zhi-Wei
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, JIANG Zhi-Wei, Jinling Hospital, China
- Investigators
- Zhi-Wei JIANG, Ph.D., Principal investigator, Jinling Hospital, Medical School of Nanjing UniversityJian ZHAO, Ph.D., Study director, Jinling Hospital, Medical School of Nanjing UniversityGang WANG, Ph.D., Study director, Jinling Hospital, Medical School of Nanjing UniversityJiang LIU, M.D., Study director, Jinling Hospital, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236051
- Sponsor's protocol ID
- 2016HR1116
- Status last verified
- Jul 2017
- First submitted
- 26 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study
- ClinicalTrials.gov ID
- NCT03236051
- Acronym / sponsor ID
- 2016HR1116
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, gastrectomy, multimodal analgesia, parecoxib
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- JIANG Zhi-WeiUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, parallel, controlled, open study.
| Arm | Type | Receives |
|---|---|---|
| multimodal analgesia | Experimental | Procedure: Multimodal analgesiaPatients received multimodal analgesia after laparoscopic gastrectomy . |
| PCIA analgesia | Active comparator | Procedure: PCIA analgesiaPatients received PCIA analgesia after laparoscopic gastrectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal analgesiaMultimodal 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 or surgery | multimodal analgesia |
| PCIA analgesiaPCIA analgesia:patient-controlled intravenous analgesia with tramadol. | Procedure or surgery | PCIA analgesia |
Primary outcome
Numeric rating scales (NRS) score with 24 hours after the surgery
Time frame: 1 day
pain evaluation
13 secondary outcomes
NRS score after 24 hours postoperatively
Time frame: 1 week
Number of remedial treatment
Time frame: 1 week
Time to first flatus
Time frame: 1 week
Time to first off-bed activity
Time frame: 1 week
Time of off-bed activity per day
Time frame: 1 week
Length of off-bed activity per day
Time frame: 1 week
Time to first semi-liquid diet
Time frame: 1 week
Postoperative length of stay
Time frame: 1 month
C-reactive protein (CRP)
Time frame: 1 week
interleukin-6 (IL-6)
Time frame: 1 week
Albumin
Time frame: 1 year
Total protein
Time frame: 1 year
Prealbumin
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal analgesia and PCIA analgesia in people with Gastric Cancer, run by JIANG Zhi-Wei at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Wei JIANG, Ph.D. (8602580860034, surgery34@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scales (NRS) score with 24 hours after the surgery (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.