Comparing tramadol and morphine for pain relief after laparoscopic abdominal surgery in adults

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What is this study about?

This study is looking at pain management after surgery in people who have postoperative pain following scheduled major laparoscopic abdominal surgery. Laparoscopic surgery is a type of operation where small cuts are made in the belly and special instruments are used instead of one large opening. The study will compare two different pain medications to see which one helps patients recover better after this type of surgery. The medications being tested are morphine sulfate, which will be given either as an injection into a vein or as tablets taken by mouth, and tramadol, which will be given as oral drops that are swallowed.

The purpose of the study is to compare how well patients recover within 24 hours after surgery when they receive pain relief with either tramadol or morphine as part of a combination approach to managing pain. Recovery will be measured using a questionnaire that asks about different aspects of how patients are feeling. Both morphine and tramadol are types of pain medications called opioids that work by affecting how the brain and body sense pain. Patients in the study will receive one of these medications during and after their surgery as part of their pain management plan.

During the study, patients will be asked to complete questionnaires at different times after surgery to assess their recovery and pain levels. The study will track how much pain medication is needed, how long patients stay in the recovery area and in the hospital, and whether any side effects occur such as nausea, vomiting, itching, or confusion. Patients will also be contacted at one month and three months after leaving the hospital to ask about ongoing pain medication use and whether they have developed long-lasting pain from the surgery. The study will look at satisfaction with pain management and assess the risk of medication misuse using specific evaluation tools.

1 Surgery and initial pain management

Your scheduled laparoscopic abdominal surgery will be performed. This is a type of surgery where small incisions are made in your abdomen and special instruments are used to perform the operation.

During the surgery, you will receive pain relief medication as part of a multimodal analgesia approach. This means that different types of pain medications are combined to manage your pain effectively.

You will be randomly assigned to receive either tramadol or morphine as your main pain medication. The specific medication, dosage, and frequency will be determined by the study protocol and your medical team.

2 Recovery in the post-anesthesia care unit

After surgery, you will be moved to the Post-Anesthesia Care Unit, also known as the recovery room, where you will be closely monitored.

Your pain level will be assessed using a numerical rating scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.

The length of your stay in the recovery room will be recorded in minutes.

You will be monitored for any side effects from the pain medication, including nausea, vomiting, difficulty breathing, itching, or confusion.

3 First 24 hours after surgery

Your pain level will be assessed at 24 hours after surgery using the numerical rating scale.

You will be asked to complete a QoR-15 questionnaire at 24 hours after surgery. This is a questionnaire with 15 questions that measures how well you are recovering after surgery, including your physical comfort, emotional state, and ability to perform daily activities.

The total amount of pain medication you have received will be calculated and converted to an equivalent dose of oral morphine for comparison purposes.

Two hours after receiving pain medication, your pain level will be assessed again to determine how effective the medication has been.

4 48 hours after surgery

You will be asked to complete the QoR-15 questionnaire again at 48 hours after surgery.

Your pain level will be assessed using the numerical rating scale.

You will continue to be monitored for any side effects from the pain medication.

5 72 hours after surgery

You will be asked to complete the QoR-15 questionnaire at 72 hours after surgery.

Your pain level will be assessed using the numerical rating scale.

The total amount of pain medication you have received since surgery will be calculated and converted to an equivalent dose of oral morphine.

You will continue to be monitored for any side effects from the pain medication.

6 Hospital discharge

The total length of your hospital stay after surgery will be recorded in days.

At the time of discharge, you will be asked to rate your satisfaction with the pain management you received on a scale from 0 to 10, where 0 means total dissatisfaction and 10 means total satisfaction.

7 One month after discharge

You will be asked whether you are still taking pain medications on a daily basis.

8 Three months after surgery

You will be asked whether you are still taking pain medications on a daily basis.

You will be assessed for the risk of medication misuse using the POMI-5F scale, which is a questionnaire designed to identify potential problems with pain medication use.

You will be asked whether you are experiencing chronic post-surgical pain, which is pain that persists for three months or longer after surgery.

Who Can Join the Study?

You must be 18 years of age or older
You must be scheduled to have laparoscopic abdominal surgery, which is a type of surgery performed through small cuts in the belly using a camera and special instruments, and the surgery is expected to last 2 hours or longer
You must be enrolled in the national health insurance system, which is the program that helps cover your medical costs
You must read, understand, and sign an informed consent form, which is a document that explains the study and confirms you agree to take part in it

Who Cannot Join the Study?

Age restrictions: You cannot participate if you are outside the age range specified for this study, which includes adults and elderly patients.
Type of surgery: You cannot participate if you are not having a scheduled major laparoscopic abdominal surgery, which is a type of surgery done through small cuts in the belly using a special camera and instruments.
Emergency surgery: You cannot participate if your surgery is an emergency rather than a planned procedure.
Allergy to pain medications: You cannot participate if you are allergic to tramadol or morphine, which are pain relief medications used in this study.
Inability to understand or complete questionnaires: You cannot participate if you are unable to understand or fill out the QoR-15 questionnaire, which is a form used to measure how well you recover after surgery.
Current use of certain pain medications: You cannot participate if you are already taking strong pain medications regularly before surgery.
Pregnancy or breastfeeding: You cannot participate if you are pregnant or breastfeeding.
Severe kidney or liver problems: You cannot participate if you have serious problems with your kidneys or liver, as these organs help process medications.
Breathing problems: You cannot participate if you have severe breathing difficulties or lung disease.
Substance abuse history: You cannot participate if you have a history of addiction to alcohol or drugs.
Mental health conditions: You cannot participate if you have certain mental health conditions that would prevent you from properly participating in the study.
Refusal to consent: You cannot participate if you do not agree to take part in the study or cannot provide your informed consent.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.10.2025

Trial locations

Investigated drugs:

Tramadol is a pain relief medication that will be given to some patients after their surgery. It works by changing how your body feels and responds to pain. In this study, it is being tested as part of a combination approach to manage pain after laparoscopic abdominal surgery.

Morphine is a strong pain relief medication that will be given to other patients after their surgery. It is commonly used to treat moderate to severe pain and works by affecting how your brain and nervous system respond to pain. In this study, it is being compared with tramadol to see which medication provides better recovery after laparoscopic abdominal surgery.

Investigated diseases:

Procedural pain

Postoperative Pain – Postoperative pain is pain that occurs after a surgical procedure as a natural response to tissue damage caused during the operation. In the case of major laparoscopic abdominal surgery, this pain results from surgical incisions, manipulation of internal organs, and stretching of tissues during the procedure. The pain typically begins immediately after surgery when anesthesia wears off and can vary in intensity depending on the type and extent of the surgical intervention. This type of pain usually decreases gradually over the first few days following surgery as tissues begin to heal. Without proper management, postoperative pain can affect patient recovery, limiting mobility and potentially leading to complications. The pain is typically most intense during the first 24 to 72 hours after surgery and continues to improve as healing progresses.

Trial ID:

2025-523327-21-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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