Study on Ropivacaine for Managing Post-Operative Pain in Patients Undergoing Lumbar Arthrodesis Surgery

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a medication called Ropivacaine in managing pain after surgery. Specifically, it looks at patients who have undergone a type of back surgery known as lumbar arthrodesis. The study aims to compare two methods of administering the medication: one method involves injecting it near the surgical area, known as a plane block, and the other involves injecting it directly into the surgical wound, known as wound infiltration.

The purpose of the study is to see if using Ropivacaine can help reduce the need for another pain medication, morphine, after surgery. Participants in the study will receive either the Ropivacaine injection or a placebo. The study will monitor how much morphine is needed in the 48 hours following surgery. Additionally, it will assess pain levels at various times after surgery, the quality of recovery, the length of hospital stay, and any side effects from the drug.

Participants will be observed for changes in their pain levels and overall recovery during the first two days after surgery. The study will also track any adverse effects related to the use of Ropivacaine during this period. This research aims to provide insights into better pain management strategies for patients undergoing lumbar arthrodesis surgery.

1 joining the study

Upon joining the study, the participant will be required to sign an Informed Consent form. This confirms understanding of the study and agreement to participate.

Eligibility criteria include being at least 18 years old, having a scheduled lumbar arthrodesis surgery, and being classified as ASA grade I-III, which refers to a scale that assesses the physical status of patients before surgery.

2 pre-surgery preparation

Before the surgery, the participant will receive detailed instructions about the procedure and the use of Ropivacaine, a medication used to manage post-operative pain.

The medication will be administered as a subcutaneous injection, which means it will be injected under the skin.

3 surgery and medication administration

During the lumbar arthrodesis surgery, the participant will receive the Ropivacaine injection. The dosage is 7.5 mg/ml, and it is used to help manage pain after the surgery.

The method of administration will be either a plane block or wound infiltration, which are techniques used to deliver the medication effectively.

4 post-surgery monitoring

After the surgery, the participant’s morphine demand will be monitored for 48 hours. This is to assess the effectiveness of the Ropivacaine in reducing the need for additional pain relief.

Pain levels will be measured using the VAS scale (Visual Analogue Scale) immediately after surgery, and at 8, 16, 24, and 48 hours post-surgery.

5 additional assessments

Further assessments will include changes in the SFMPQ (Short-Form McGill Pain Questionnaire) and QoR-15 (Quality of Recovery) scales at 24 and 48 hours after surgery.

The duration of hospitalization and any adverse effects associated with the drug within the first 48 hours will also be recorded.

6 completion of trial participation

Once all assessments are completed, the participant’s involvement in the trial will conclude.

The data collected will contribute to understanding the efficacy and safety of Ropivacaine in managing post-operative pain.

Who Can Join the Study?

Participant must be 18 years old or older at the time of signing the consent form.
Participant must have a lumbar arthrodesis (a type of back surgery) scheduled.
Participant must be classified as ASA grade I-III, which means they are in a health status ranging from healthy to having mild to severe systemic disease.
Participant must be capable of giving Informed Consent, meaning they understand the study and agree to participate.

Who Cannot Join the Study?

Patients who have had a recent surgery other than lumbar arthrodesis (a type of back surgery).
Patients with a history of allergic reactions to morphine or similar medications.
Patients with severe liver or kidney problems.
Patients with a history of drug or alcohol abuse.
Patients who are pregnant or breastfeeding.
Patients with uncontrolled high blood pressure.
Patients with severe heart conditions.
Patients with active infections.
Patients who are currently participating in another clinical trial.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	13.01.2025

Trial locations

Investigated drugs:

Ropivacaine Hydrochloride

Ropivacaine is a medication used to numb a specific area of the body to help manage pain after surgery. In this clinical trial, it is being tested to see how well it can reduce the need for other pain medications, like morphine, after lumbar spine surgery. The study is comparing two ways of using Ropivacaine: one method involves injecting it near the nerves that send pain signals from the surgical area, and the other involves injecting it directly into the surgical wound. The goal is to find out which method provides better pain relief and reduces the need for additional pain medication.

Degenerative Disc Disease – This condition involves the gradual deterioration of the intervertebral discs, which are the cushions between the bones of the spine. Over time, these discs can lose their flexibility, elasticity, and shock-absorbing characteristics. As the discs degenerate, they may cause pain, weakness, or numbness in the back and limbs. The progression can lead to the development of bone spurs and herniated discs. Symptoms often worsen with physical activity and improve with rest. The condition can lead to chronic pain and reduced mobility over time.

Trial ID:

2024-511406-23-00

Protocol code:

ROPIDOL

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ropivacaine for Managing Post-Operative Pain in Patients Undergoing Lumbar Arthrodesis Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?