Study on Pain Relief After Obesity Surgery Using Esketamine, Dexmedetomidine, and Lidocaine Hydrochloride Monohydrate for Patients Undergoing Obesity Surgery

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What is this study about?

This clinical trial is focused on patients undergoing surgery for obesity, specifically looking at how to manage postoperative pain without relying heavily on opioids, which are strong pain-relieving drugs. The study will explore the effects of an opioid-sparing care pathway, which means using alternative methods and medications to reduce the need for opioids. The medications being studied include esketamine, dexmedetomidine, lidocaine hydrochloride monohydrate, and remifentanil hydrochloride. These medications are used in different forms, such as solutions for injection or infusion, to help manage pain and aid recovery after surgery.

The purpose of the study is to compare this new approach to the traditional opioid-based treatment in terms of pain relief, recovery after surgery, and overall health outcomes. Participants will receive either the new treatment or the conventional treatment, which may include a placebo. The study will monitor various aspects of recovery, including pain levels, the amount of opioids used, and the patient’s ability to recover and return to normal activities. The study will also look at how this approach affects the patient’s confidence in managing unexpected events and their quality of life over time.

Throughout the study, participants will be observed at different intervals, such as immediately after surgery, during their hospital stay, and at several points after discharge, including 3, 6, 12, and 24 months later. The goal is to see if the opioid-sparing approach can provide effective pain management and improve recovery without the side effects associated with high opioid use. This research aims to offer better pain management strategies for patients undergoing obesity surgery, potentially leading to improved health outcomes and quality of life.

1 joining the study

Participation begins after providing informed consent and meeting the criteria for laparoscopic obesity surgery.

The study focuses on evaluating pain management methods during and after surgery.

2 pre-surgery preparation

Preparation involves understanding the use of an opioid-sparing care pathway compared to traditional opioid-based treatments.

Medications such as esketamine, dexmedetomidine, lidocaine hydrochloride monohydrate, and remifentanil hydrochloride are administered through infusion or injection.

3 surgery and immediate recovery

During surgery, the focus is on minimizing opioid use while managing pain effectively.

Post-surgery, pain levels are monitored using the Numeric Rating Scale (NRS) to assess pain relief.

4 postoperative care

Pain management continues with the opioid-sparing approach, aiming to reduce opioid consumption.

Recovery is assessed using the Postoperative Quality of Recovery Scale (PQRS) at various intervals: 20 minutes, 40 minutes, 24-72 hours, and up to 24 months.

5 long-term follow-up

Follow-up assessments occur at 3, 6, 12, and 24 months to evaluate recovery, self-efficacy, and quality of life.

The study examines the impact on long-term use of pain medications and overall health outcomes.

Who Can Join the Study?

  • Patients must be 18 years or older.
  • Patients should be scheduled for laparoscopic obesity surgery. This includes types of surgery like GBP (Gastric Bypass) or Sleeve surgery.
  • Patients need to agree to participate in the study by giving their informed consent. This means they understand the study and agree to be part of it.
  • Both men and women can participate.
  • The study is not for people considered part of a vulnerable population. This means people who might need extra protection or care are not included.

Who Cannot Join the Study?

  • Patients who are not undergoing obesity surgery.
  • Patients who are not experiencing postoperative pain.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Region Oerebro Laen Orebro Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
01.05.2019

Trial locations

Opioid Sparing Care Pathway
This is a treatment approach designed to reduce or eliminate the use of opioids for pain relief in patients undergoing obesity surgery. The goal is to manage pain effectively while minimizing the side effects and risks associated with opioid use. This pathway may include the use of alternative pain management strategies such as non-opioid medications, physical therapy, and other supportive measures to enhance recovery and improve overall outcomes.

Conventional Opioid-Based Treatment
This is the standard approach to managing pain in patients undergoing obesity surgery, which involves the use of opioid medications. Opioids are powerful pain relievers that work by blocking pain signals in the brain. While effective, they can have side effects and carry a risk of dependency. This treatment is used as a comparison to evaluate the benefits of the opioid sparing care pathway.

Investigated diseases:

Pain, postoperative – This condition refers to the discomfort or pain experienced by patients following surgical procedures. It typically arises due to tissue damage and inflammation caused by the surgery. The intensity and duration of postoperative pain can vary depending on the type of surgery and individual patient factors. Pain is usually most intense immediately after surgery and tends to decrease over time as the body heals. Effective management of postoperative pain is crucial for patient comfort and recovery. Without proper management, it can lead to complications such as delayed healing or chronic pain.

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It is typically measured using the Body Mass Index (BMI), with a BMI of 30 or higher indicating obesity. The condition develops over time due to an imbalance between calorie intake and energy expenditure. Factors contributing to obesity include genetics, lifestyle choices, and environmental influences. Obesity can lead to various health issues, including heart disease, diabetes, and joint problems. Managing obesity often involves lifestyle changes such as diet and exercise.

Trial ID:
2023-505934-86-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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