Active drug
DrugInjection of Ropivacaine
Other names: Ropivacaine
NCT Number: NCT04311099
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Sydvestjysk Sygehus, Esbjerg, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of Ropivacaine
Other names: Ropivacaine
Injection of Saline solution
Other names: Saline solution
Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
Lateral ultrasound-guided transverse abdominal plane block with saline solution
Laparoscopic assisted subcostal transverse abdominal plane block with saline solution
Time frame: The first 24 hours from the end of anesthesia.
Intravenously in milligrams.
Time frame: Up to 12 hours.
Intravenously in milligrams.
Time frame: The first 24 hours from the end of anesthesia.
Intravenously in milligrams.
Time frame: Postoperative Day 1.
11-point Numeric Rating Scale. 0-10 (higher score - worse outcome).
Time frame: Postoperative Day 1.
11-point Numeric Rating Scale. 0-10 (higher score means worse outcome)
Time frame: Up to 30 days.
Days - Measured from the end of anesthesia.
Time frame: Postoperative Day 1.
4-point Numeric Rating Scale. 0-3 (higher score means worse outcome).
Time frame: In the first 24 hours from the end of anesthesia.
Intravenously in milligrams.
Time frame: Up to 12 hours.
Intravenously in milligrams.
Time frame: Up to 30 hours.
From the end of anesthesia to discharge to ward. Measured in hours and minutes.
Time frame: Postoperative Day 1.
4-point Verbal Rating Scale. 1-4 (higher score means worse outcome).
Time frame: Postoperative Day 1.
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.
Time frame: Postoperative Day 30.
According to the Clavien-Dindo classification of surgical complications.
Time frame: Postoperative Day 30.
Epidural or TAP-block administered post surgery.
Claus Anders Bertelsen, PhD, MD
Other
Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colon Surgery: A Randomized Controlled Multicentre Clinical Trial
Acronym: OPMICS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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