Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Bupivacaine Hydrochloride and Sodium Chloride for Recovery After Minimally Invasive Colorectal Surgery

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on improving recovery after minimally invasive colorectal surgery, which is a type of surgery performed on the colon or rectum using small incisions. The study will explore the effects of a treatment called Continuous Wound Infiltration, where a local pain relief medication, Bupivacaine, is continuously delivered to the surgical wound. This medication is a type of anesthetic that helps numb the area to reduce pain. The trial will compare the effects of this treatment to a placebo, which is a substance with no active medication, to see if it helps patients recover better after surgery.

The main goal of the study is to determine if using Bupivacaine in this way can improve the recovery process for patients who have undergone minimally invasive colorectal surgery. Participants in the study will receive either the Bupivacaine treatment or a placebo. The study will monitor their recovery over a period of time, focusing on how well they feel and how quickly they return to normal activities. The study will also track pain levels and the use of additional pain medications during the recovery period.

Throughout the study, participants will be asked to complete a daily questionnaire about their recovery, which will include questions about their pain levels and overall well-being. This information will help researchers understand the effectiveness of the treatment. The study will continue to collect data on participants' recovery and any complications that may arise for up to 90 days after surgery. The findings from this study could provide valuable insights into improving post-surgical care for patients undergoing minimally invasive colorectal surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility criteria include being 18 years or older, scheduled for minimally invasive colorectal surgery, and having provided written informed consent.

  2. Step 2

    Surgery and initial treatment

    The trial involves continuous wound infiltration with local pain relief medication following elective minimally invasive colorectal surgery.

    The medications used are bupivacaine hydrochloride, anhydrous and sodium chloride, both administered as a solution for injection through a method called parenteral administration.

  3. Step 3

    Postoperative recovery monitoring

    Postoperative recovery is measured using the Quality of Recovery (QoR) Questionnaire score. This is conducted daily from the first postoperative day until the fifth postoperative day.

    The questionnaire is completed digitally using an electronic case report form (eCRF) in a secure study database.

  4. Step 4

    Pain and medication assessment

    Postoperative pain levels are recorded using the Numeric Rating Scale (NRS) within the daily questionnaire.

    The nursing staff also records the NRS score daily during the hospital stay.

    Postoperative use of pain relief medication is documented in the daily questionnaire and by the treating physician.

  5. Step 5

    Discharge and recovery documentation

    The date of discharge and functional recovery are noted in the patient file by the treating physician.

    Possible complications are recorded from the date of surgery up to 90 days after surgery and are graded according to a standard classification system.

  6. Step 6

    Completion of trial participation

    The trial is estimated to end on November 1, 2026, with recruitment starting on October 1, 2024.

Who can join the trial?

3 criteria

  • Must be 18 years or older.
  • Must be scheduled for minimally invasive colorectal surgery. This means a planned surgery on the colon or rectum using small cuts and special tools.
  • Must have provided written informed consent. This means you have agreed to participate in the study after being fully informed about it and have signed a document to confirm your agreement.

Who cannot join the trial?

5 criteria

  • Patients who have not undergone **minimally invasive colorectal surgery**. This is a type of surgery on the colon or rectum that uses small cuts and special tools to reduce recovery time.
  • Patients who are not scheduled for **elective surgery**. Elective surgery is planned in advance and is not an emergency.
  • Patients who are not able to receive **local analgesics**. These are medications used to numb a specific area of the body to reduce pain.
  • Patients who are not in the specified **age range** for the study. The study has specific age requirements for participants.
  • Patients who are part of a **vulnerable population**. This means groups of people who might need special protection or care.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Local Analgesics: In this trial, local analgesics are used for continuous wound infiltration. These medications are intended to manage pain by numbing the area around the surgical wound. The goal is to improve post-operative recovery by reducing pain and discomfort after minimally invasive colorectal surgery.

What is already known about the treatment

Local Analgesics – These medications are administered through continuous wound infiltration, where the analgesic is delivered directly to the surgical site. Currently, they are being studied in clinical trials to assess their effectiveness in aiding recovery after minimally invasive colorectal surgery. The main therapeutic indication is to enhance post-operative recovery by reducing pain and discomfort. At the molecular level, local analgesics work by blocking nerve signals in the area where they are applied, preventing pain sensations from reaching the brain. They are classified pharmacologically as local anesthetics.

Investigated diseases

Recovery following elective minimally invasive colorectal surgery – This condition refers to the healing process after a planned, non-emergency surgery that involves small incisions to remove or repair parts of the colon. The recovery process involves the body's natural healing mechanisms to restore normal function and health. Patients may experience varying levels of pain, which can affect their overall recovery experience. The use of local analgesics can help manage pain and potentially improve the quality of recovery. Monitoring includes assessing pain levels, medication use, and any complications that may arise. The goal is to achieve functional recovery and discharge from the hospital as smoothly as possible.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512107-39-00Protocol code2024-512107-39Estimated enrolment192 patientsSponsorCatharina Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.