Effect of Intraperitoneal Ropivacaine on Visceral Pain After Laparoscopic Gastrectomy

NCT06145945 | Unknown DMC

• 1 other identifier: 2023ZSLYEC-502
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Visceral pain is obvious and lasts for a long time in patients after laparoscopic gastrectomy.Relieving the visceral pain is of great significance for patients' postoperative emotional experience, functional recovery and reducing the formation of long-term chronic pain. However, there is no clear clinical consensus on relieving visceral pain by now, so effective clinical methods to relieve visceral pain need to be explored urgently. Intraperitoneal spraying local anesthetics is a simple and inexpensive method, which has been proved to be safe and effective in randomized controlled trials and Meta-analysis of various types of surgery.However, its effect in clinical research is still controversial and many studies lack evaluation of postoperative recovery quality, so it has not been widely used in clinical practice. This study aims to explore the effect of intraperitoneal spraying ropivacaine (long-acting amide local anesthetic) on visceral pain after laparoscopic gastrectomy, and to systematically evaluate its effect on the recovery of gastrointestinal function and the inflammatory factors (IL-6, TNF-α) in abdominal drainage fluid.

Conditions

Laparoscopic Gastrectomy; Ropivacaine

Keywords

visceral pain

Outcome Measures

Primary Outcomes (1)

• NRS scores of visceral pain

  NRS scores of visceral pain at 24 hours after surgery

  24 hours after surgery

Secondary Outcomes (24)

• NRS scores of visceral pain

  From surgery completion to the 30th day after surgery

• NRS scores of incisional pain

  From surgery completion to the 30th day after surgery

• NRS scores of referred pain

  From surgery completion to the 30th day after surgery

• Blood pressure(SBP,DBP,MAP)

  From the period of anesthesia to the third day after surgery

• Heart rate

  From the period of anesthesia to the third day after surgery

Study Arms (2)

Ropivacaine

EXPERIMENTAL

20ml 0.5% ropivacaine is sprayed intraperitoneally

Drug: 0.5% Ropivacaine

Saline

PLACEBO COMPARATOR

20ml saline is sprayed intraperitoneally

Drug: Saline

Interventions

0.5% Ropivacaine DRUG

20ml 0.5% ropivacaine is sprayed intraperitoneally

Also known as: Ropivacaine

Ropivacaine

Saline DRUG

20ml saline is sprayed intraperitoneally

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• The American Society of Anesthesiologists(ASA) grade is I or II, and the heart function grade is 1-2;
• Elective laparoscopic gastrectomy under general anesthesia

You may not qualify if:

• Patients have severe heart, lung, liver, and kidney diseases (heart function grade\>3 / respiratory failure / liver failure / renal failure)
• BMI\<18kg/m2 or \>30kg/m2
• Patients with chronic pain other than stomach pain and taking analgesics for a long time
• Patients with history of allergy to local anesthetics
• Patients with high risk of reflux and aspiration such as digestive obstruction
• Patients who refuse to participate or don't sign or refuse to sign the informed consent form
• Patients who are unable to communicate effectively
• Patients participate in other clinical trials

Sponsors & Collaborators

• SanQing Jin: lead

Study Sites (1)

SanQing Jin

Guangzhou, Guangdong, China

Location

Related Publications (18)

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  PMID: 28426553 BACKGROUND

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  PMID: 34693999 BACKGROUND

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MeSH Terms

Conditions

Visceral Pain

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• SanQing Jin, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SanQing Jin, MD

CONTACT

0086-13719366863; sanqingjin@hotmail.com

Huilin Xie, MB

CONTACT

0086-15979587677; 306448236@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 24, 2023
• Study Start: November 25, 2023
• Primary Completion: March 3, 2024
• Study Completion: July 7, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)