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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04575233
• Other study ID #: TAP block
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: January 11, 2022

Study information

• Verified date: July 2022
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: January 11, 2022
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Laparoscopic Colectomy
• Pain, Postoperative

Intervention

Procedure:
• laparoscopic-assisted Transversus Abdominis Plane (TAP) block
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.
• ultrasound-assisted Transversus Abdominis Plane (TAP) block
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.

Drug:
• Ropivacaine
a solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block)

Locations

Country	Name	City	State
Switzerland	Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale	Bellinzona
Switzerland	Ospedale Regionale di Lugano, Civico e Italiano - Ente Ospedaliero Cantonale	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Davide La Regina

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioids consumption	Opioid consumption measured in morphine milligram equivalents (MME) per day	24 hours from surgery
Secondary	Opioid consumption within the first 48 hours after the operation	Opioid consumption measured in morphine milligram equivalents (MME) per day	48 hours from surgery
Secondary	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
Secondary	length of hospital stay	number of days the participant is being hospitalized	during hospitalization,approximately 6 days
Secondary	Time required to perform the (Transversus Abdominis Plane) TAP block		during procedure