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Pain

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Ropivacaine

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Cola

Ultrasound-guided TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and laparoscopic assisted injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Laparoscopic assisted TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Laparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Active drug

Placebo

Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml

Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block

Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml

Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block

Lateral ultrasound-guided transverse abdominal plane block with saline solution

Injection of placebo - Ultrasound-guided transverse abdominal plane block

Laparoscopic assisted subcostal transverse abdominal plane block with saline solution

Injection of placebo - Laparoscopic assisted transverse abdominal plane block

Claus A Bertelsen, PhD

Christopher B Salmonsen, MD

Victor J Verwall, PhD

Anders H Madsen, PhD

Uffe S Løwe, PhD

The purpose of the trial is to identify the "most simple non-inferior of three different methods", placebo, laparoscopic assisted transverse abdominal plane block (L-TAP) and ultrasound guided TAP block (US-TAP), using postoperative opioid consumption as a measure of efficacy in patients undergoing elective minimally invasive colon surgery in an ERAS setting. Postoperative pain scores and length of stay (LOS) will also be measured. The simplicity of the three methods is ranked as: 1) placebo, 2) L-TAP and 3) US-TAP.

Introducing laparoscopy in colorectal surgery and optimizing the postoperative care using the standardized protocols of enhanced recovery after surgery (ERAS) have significantly improved patient outcomes and LOS. Better pain management has the potential to further improve these outcomes. Since the introduction of ultrasound-guided abdominal wall blocks, much research has been done in that field, but no consensus has been reached concerning the optimal block technique; where to and when to inject the block, or which drug to use. Newly published randomized controlled trials show interesting results regarding the L-TAP which has several advantages to the US-TAP, including the ease of performance, less dependency on specialized skills or equipment and avoidance of intraperitoneal infiltration. but these results need to be solidified with multicentre trials. Besides optimizing postoperative pain management, better block techniques could potentially decrease LOS in patients after minimally invasive colorectal surgery.

Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery

Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colon Surgery: A Randomized Controlled Multicentre Clinical Trial

After de-identification, individual participant data will be made available to investigators who provide a methodologically sound proposal for meta-analyses. Proposals should be directed to Claus A Bertelsen (cabertelsen@gmail.com). A Data Processing Agreement according to the EU General Data Protection Regulation has to be signed before data sharing.

11-point Numeric Rating Scale. 0-10 (higher score - worse outcome).

11-point Numeric Rating Scale. 0-10 (higher score means worse outcome)

Days - Measured from the end of anesthesia.

4-point Numeric Rating Scale. 0-3 (higher score means worse outcome).

From the end of anesthesia to discharge to ward. Measured in hours and minutes.

4-point Verbal Rating Scale. 1-4 (higher score means worse outcome).

The Quality of Recovery 15 is a 15-item questionnaire that measures the patient's quality of recovery. Each item is answered on an 11-point Numerical Rating Scale. The score ranges from 0 to 150 with a higher score indicating a better quality of recovery. It measures in the domains of pain, physical comfort, physical independence, psychological support, and emotional state.

According to the Clavien-Dindo classification of surgical complications.

Epidural or TAP-block administered post surgery.

Spots Global Cancer Trial Database for active drug

Every month we try and update this database with for active drug cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for active drug

Every month we try and update this database with for active drug cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for active drug cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.