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A study comparing TAP block versus QL block with ropivacaine for pain management after laparoscopic colon resection in patients with colon cancer or diverticulosis

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial focuses on comparing pain management methods after laparoscopic colon resection. The study involves patients undergoing colon surgery due to either colon cancer or diverticulosis (a condition where small pouches form in the wall of the colon). The main medication used in the study is ropivacaine hydrochloride, a local anesthetic that helps control pain.

The study aims to evaluate the effectiveness of two different nerve block techniques: Transversus Abdominis Plane block and Quadratus Lumborum block. These are methods where pain-relieving medication is injected near specific muscles in the abdomen to reduce pain during and after surgery. The medication will be administered through a technique called perineural use, which means it is placed around specific nerves.

During the study, patients will receive one of these nerve block treatments, and their pain levels will be monitored. The maximum daily dose of the pain medication is 675 mg/ml. Patients will be observed for pain control, need for additional pain medication, and overall recovery after surgery. The study will also track other factors such as nausea, bowel function, and overall satisfaction with the pain control method.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial pain management procedure
You will receive one of two types of nerve blocks: either a Transversus abdominis plane block or a Quadratus lumborum block during your laparoscopic colon surgery
The pain medication used will be ropivacaine, administered through a nerve block
Step 2
Pain monitoring in hospital - first 24 hours
Your pain levels will be checked every 4 hours using a pain scale from 0 to 10
If your pain level exceeds 3, you will receive additional pain medication (oxycodone) either through an IV in the recovery room or orally on the ward
Any nausea or vomiting will be monitored every 4 hours
Your bowel function will be monitored
Step 3
Hospital stay monitoring
Pain levels will be checked three times per day
Your total pain medication usage will be tracked
You will be asked to rate your satisfaction with the pain management (scale 0-10)
Step 4
At-home monitoring - first week
You will need to maintain a daily diary for one week
Continue recording pain levels three times per day
Step 5
Follow-up - 4 weeks after surgery
You will have a follow-up appointment
You will complete questionnaires about your pain experience
Your overall satisfaction with the pain management will be evaluated

Who can join the trial?

8 criteria

Age between 18 and 99 years old
Scheduled to undergo colon resection surgery (a surgical procedure to remove part of the large intestine)
Diagnosed with either colon cancer or diverticulosis (a condition where small pouches form in the wall of the colon)
Both male and female patients can participate
Must be scheduled for laparoscopic surgery (minimally invasive procedure performed through small incisions)
Able to understand and follow the study requirements
Must not belong to any vulnerable population groups
Must be scheduled for a planned procedure (not emergency surgery)

Who cannot join the trial?

12 criteria

Patient with allergy or hypersensitivity to local anesthetics
Patient with blood clotting disorders or taking blood-thinning medications
Patient with infection at or near the planned injection site
Patient who is unable to give informed consent
Patient with significant heart, lung, or liver disease that could increase surgical risks
Patient with chronic pain conditions requiring regular opioid medications
Patient who is pregnant or breastfeeding
Patient with previous abdominal surgery in the same area
Patient with body mass index (BMI) above 40 (severe obesity)
Patient with known anatomical abnormalities that would make the procedure technically difficult
Patient with psychiatric conditions that might interfere with pain assessment
Patient participating in another clinical trial within the past 30 days

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Verified sites

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Pirkanmaan hyvinvointialue
Verified
Tampere, Finland

Trial locations

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Investigated drugs

Based on the provided data about a trial comparing pain management methods after laparoscopic colon resection, the treatments involved are: Transversus Abdominis Plane (TAP) block is a pain management technique where local anesthetic is injected into the abdominal wall between specific muscle layers. This nerve block helps control pain in the abdomen after surgery. Quadratus Lumborum (QL) block is a regional anesthesia technique where local anesthetic is administered near the quadratus lumborum muscle in the lower back. This block provides pain relief to the abdomen and lower back after abdominal surgery. Both techniques are used as part of multimodal pain management strategies following laparoscopic colon surgery, aiming to reduce post-operative pain and the need for other pain medications.

Ropivacaine Hydrochloride

What is already known about the treatment

Based on the provided clinical trial data, I can describe the medications/procedures mentioned: Transversus Abdominis Plane (TAP) Block - A regional anesthesia technique where local anesthetic is injected into the abdominal wall between muscle layers to provide post-operative pain control for patients undergoing laparoscopic colon resection. This procedure is administered by anesthesiologists through ultrasound guidance, targeting specific nerve pathways to reduce pain after abdominal surgery. It is widely recognized in medical literature as an effective component of multimodal pain management protocols. Quadratus Lumborum (QL) Block - An advanced regional anesthesia technique that involves injecting local anesthetic near the quadratus lumborum muscle to provide pain relief for abdominal surgery patients. This block is performed under ultrasound guidance and provides broader coverage of pain control compared to TAP blocks due to its spread into multiple tissue planes. It has gained increasing attention in medical literature as an effective method for managing post-operative pain in laparoscopic procedures.

Investigated diseases

Colon Cancer
A disease that begins in the large intestine (colon), where cells begin to grow abnormally and form tumors. It typically develops slowly over several years, often starting as small, benign clumps of cells called polyps. The cancer usually affects the inner wall of the colon first, and can later spread through the colon wall to nearby structures.
Diverticulosis
A condition where small pouches (diverticula) form in the wall of the colon. These pouches bulge outward through weak spots in the colon wall, most commonly in the lower part of the large intestine. The condition becomes more common with age and is often associated with low-fiber diets. While many people with diverticulosis don't experience symptoms, the condition can progress and cause discomfort.