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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03236051
• Other study ID #: 2016HR1116
• Status: Recruiting
• Phase: N/A
• First received: July 26, 2017
• Last updated: July 27, 2017
• Start date: February 10, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: July 2017
• Source: Jinling Hospital, China
• Contact: Zhi-Wei JIANG, Ph.D.
• Phone: 8602580860034
• Email: surgery34[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: August 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Multimodal 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.
• PCIA analgesia
PCIA analgesia:patient-controlled intravenous analgesia with tramadol.

Locations

Country	Name	City	State
China	Jinling Hospital, Medical School of Nanjing University	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
JIANG Zhi-Wei	Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating scales (NRS) score with 24 hours after the surgery	pain evaluation	1 day
Secondary	NRS score after 24 hours postoperatively	pain evaluation	1 week
Secondary	Number of remedial treatment	pain evaluation	1 week
Secondary	Time to first flatus	Bowel function recovery	1 week
Secondary	Time to first off-bed activity	Postoperative activity	1 week
Secondary	Time of off-bed activity per day	Postoperative activity	1 week
Secondary	Length of off-bed activity per day	Postoperative activity	1 week
Secondary	Time to first semi-liquid diet	Bowel function recovery	1 week
Secondary	Postoperative length of stay	postoperative length of stay	1 month
Secondary	C-reactive protein (CRP)	Inflammatory indicators	1 week
Secondary	interleukin-6 (IL-6)	Inflammatory indicators	1 week
Secondary	Albumin	Nutritional status	1 year
Secondary	Total protein	Nutritional status	1 year
Secondary	Prealbumin	Nutritional status	1 year