A Study to Compare Laparoscopic to Echographic Assisted Transversus Abdominis Plane Block in Laparoscopic Colectomy

Study Overview
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Brief Summary
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The purpose of this study is to compare the postoperative pain, the time needed and other clinical outcomes in patients who, during laparoscopic colectomy, will be injected with a local anesthetic (Ropivacaine) through an ultrasound guided technique performed by the anaesthesiologist or throught a laparoscopic assisted technique performed by the surgeon

Official Title
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Laparoscopic- Vs Ultrasound-guided Transversus Abdominis Plane Block in Laparoscopic Colectomy: a Prospective Randomized Controlled Trial

Conditions
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Laparoscopic Colectomy, Pain, Postoperative

Intervention / Treatment
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* Procedure: laparoscopic-assisted Transversus Abdominis Plane (TAP) block
* Procedure: ultrasound-assisted Transversus Abdominis Plane (TAP) block
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients candidates to laparoscopic colorectal surgery Signed informed consent Exclusion Criteria: Age < 18 years old Pregnancy Allergy to local anaesthetics Spinal or epidural analgesia Acute inflammatory abdominal pathologies Chronic pain syndrome Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDS)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Transversus Abdominis Plane (L-TAP) group<br>Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under laparoscopic control | Procedure: laparoscopic-assisted Transversus Abdominis Plane (TAP) block<br>* The anterior axillary line is used as landmarks. After insertion of the optic trocar, the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. A solution of 15 ml of Ropivacaine (0.2%) is then injected. The procedure is performed then 2 cm caudal to the first landmark on the same side. The procedure is than repeated identically on the contralateral side.<br>Drug: Ropivacaine<br>* a solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block)<br>|
| Active Comparator: Ultrasound Transversus Abdominis Plane (U-TAP) group<br>Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under ultrasound control | Procedure: ultrasound-assisted Transversus Abdominis Plane (TAP) block<br>* Whilst the patient is in the supine position, a high frequency ultrasound probe is placed transverse to the abdominal wall between the costal margin and iliac crest. The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles. Then 15 ml of local anaesthetic solution is injected. The needle is than retracted until its tip is positioned in the fascial plane between the internal and the external oblique muscles and a second bolus of 15 ml of local anaesthetic is injected. The procedure is than repeated identically on the contralateral side.<br>Drug: Ropivacaine<br>* a solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioids consumption | Opioid consumption measured in morphine milligram equivalents (MME) per day | 24 hours from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption within the first 48 hours after the operation | Opioid consumption measured in morphine milligram equivalents (MME) per day | 48 hours from surgery | 
| postoperative pain | Postoperative pain on the visual analogue scale (VAS) at 3, 6, 12, 24 hours. This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain. | at 3, 6, 12, 24 hours from surgery | 
| length of hospital stay | number of days the participant is being hospitalized | during hospitalization,approximately 6 days | 
| Time required to perform the (Transversus Abdominis Plane) TAP block |  | during procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transversus Abdominis Plane (TAP) Block, Local Anesthetic Infiltrations