Clinical trial NCT03236051: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: gastric cancer
gastrectomy
multimodal analgesia
parecoxib
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2017-08-01
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, parallel, controlled, open study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric rating scales (NRS) score with 24 hours after the surgery
timeFrame: 1 day
Secondary outcomes:
measure: NRS score after 24 hours postoperatively
timeFrame: 1 week
measure: Number of remedial treatment
timeFrame: 1 week
measure: Time to first flatus
timeFrame: 1 week
measure: Time to first off-bed activity
timeFrame: 1 week
measure: Time of off-bed activity per day
timeFrame: 1 week
measure: Length of off-bed activity per day
timeFrame: 1 week
measure: Time to first semi-liquid diet
timeFrame: 1 week
measure: Postoperative length of stay
timeFrame: 1 month
measure: C-reactive protein (CRP)
timeFrame: 1 week
measure: interleukin-6 (IL-6)
timeFrame: 1 week
measure: Albumin
timeFrame: 1 year
measure: Total protein
timeFrame: 1 year
measure: Prealbumin
timeFrame: 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital, Medical School of Nanjing University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Zhi-Wei JIANG, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Jian ZHAO, Ph.D.
role: STUDY_DIRECTOR
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Gang WANG, Ph.D.
role: STUDY_DIRECTOR
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Jiang LIU, M.D.
role: STUDY_DIRECTOR
References: