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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04575233
Enrollment
116
Registered
2020-10-05
Start date
2018-01-15
Completion date
2022-01-11
Last updated
2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Colectomy, Pain, Postoperative

Keywords

Transversus Abdominis Plane (TAP) Block, Local Anesthetic Infiltrations

Brief 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

Interventions

PROCEDURElaparoscopic-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.

PROCEDUREultrasound-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.

DRUGRopivacaine

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

Sponsors

Davide La Regina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Opioids consumption24 hours from surgeryOpioid consumption measured in morphine milligram equivalents (MME) per day

Secondary

MeasureTime frameDescription
Opioid consumption within the first 48 hours after the operation48 hours from surgeryOpioid consumption measured in morphine milligram equivalents (MME) per day
postoperative painat 3, 6, 12, 24 hours from surgeryPostoperative 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.
length of hospital stayduring hospitalization,approximately 6 daysnumber of days the participant is being hospitalized
Time required to perform the (Transversus Abdominis Plane) TAP blockduring procedure

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026