Laparoscopic ColectomyNCT04575233
A Study to Compare Laparoscopic to Echographic Assisted Transversus Abdominis Plane Block in Laparoscopic Colectomy
A study testing laparoscopic-assisted Transversus Abdominis Plane (TAP) block, ultrasound-assisted Transversus Abdominis Plane (TAP) block and Ropivacaine in people with Laparoscopic Colectomy and Pain, Postoperative, run by Davide La Regina at 2 sites in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Colectomy, Pain, Postoperative
- What is being tested?
- laparoscopic-assisted Transversus Abdominis Plane (TAP) block, ultrasound-assisted Transversus Abdominis Plane (TAP) block and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 15 Jan 2018to 11 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients candidates to laparoscopic colorectal surgery
- Signed informed consent
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale
Bellinzona
Ospedale Regionale di Lugano, Civico e Italiano - Ente Ospedaliero Cantonale
Lugano, 6900
About this study
Official title: Laparoscopic- Vs Ultrasound-guided Transversus Abdominis Plane Block in Laparoscopic Colectomy: a Prospective Randomized Controlled Trial
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
- Conditions
- Laparoscopic Colectomy, Pain, Postoperative
- Being tested
- laparoscopic-assisted Transversus Abdominis Plane (TAP) block, ultrasound-assisted Transversus Abdominis Plane (TAP) block, Ropivacaine
- Keywords
- Transversus Abdominis Plane (TAP) Block, Local Anesthetic Infiltrations
- Medical subject headings
- Pain, Postoperative, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic-assisted Transversus Abdominis Plane (TAP) blockProcedure or surgery
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) blockProcedure or surgery
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.
RopivacaineDrug
a solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block)
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Transversus Abdominis Plane (L-TAP) group | Experimental | 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 Receives: Procedure: laparoscopic-assisted Transversus Abdominis Plane (TAP) block; Drug: Ropivacaine |
| Ultrasound Transversus Abdominis Plane (U-TAP) group | Active comparator | 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 Receives: Procedure: ultrasound-assisted Transversus Abdominis Plane (TAP) block; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioids consumption
Opioid consumption measured in morphine milligram equivalents (MME) per day
Measured: 24 hours from surgery
Secondary outcomes (4)
Opioid consumption within the first 48 hours after the operation
Opioid consumption measured in morphine milligram equivalents (MME) per day
Measured: 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.
Measured: at 3, 6, 12, 24 hours from surgery
length of hospital stay
number of days the participant is being hospitalized
Measured: during hospitalization,approximately 6 days
Time required to perform the (Transversus Abdominis Plane) TAP block
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start15 Jan 2018
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic ColectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Davide La Regina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Davide La Regina, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Davide La Regina, MD, Study chair, Ente Ospedaliero Cantonale (EOC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575233
- Sponsor's protocol ID
- TAP block
- Status last verified
- Jul 2022
- First submitted
- 18 Sep 2020
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
La Regina D, Popeskou SG, Saporito A, Gaffuri P, Tasciotti E, Dossi R, Christoforidis D, Mongelli F. Laparoscopic versus ultrasound-guided transversus abdominis plane block in colorectal surgery: a non-inferiority, multicentric randomized double-blinded clinical trial. Colorectal Dis. 2023 Sep;25(9):1921-1928. doi: 10.1111/codi.16689. Epub 2023 Jul 31.
PubMed 37525414
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic- Vs Ultrasound-guided Transversus Abdominis Plane Block in Laparoscopic Colectomy: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04575233
- Acronym / sponsor ID
- TAP block
- Conditions
- Laparoscopic Colectomy, Pain, Postoperative
- Keywords
- Transversus Abdominis Plane (TAP) Block, Local Anesthetic Infiltrations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Davide La ReginaUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Transversus Abdominis Plane (L-TAP) group | Experimental | Procedure: laparoscopic-assisted Transversus Abdominis Plane (TAP) block, Drug: RopivacainePatients 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 |
| Ultrasound Transversus Abdominis Plane (U-TAP) group | Active comparator | Procedure: ultrasound-assisted Transversus Abdominis Plane (TAP) block, Drug: RopivacainePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients candidates to laparoscopic colorectal surgery
- Signed informed consent
Key exclusion criteria (7 listed)
- Age < 18 years old
- Pregnancy
- Allergy to local anaesthetics
- Spinal or epidural analgesia
- Acute inflammatory abdominal pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic-assisted Transversus Abdominis Plane (TAP) blockThe 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. | Procedure or surgery | Laparoscopic Transversus Abdominis Plane (L-TAP) group |
| ultrasound-assisted Transversus Abdominis Plane (TAP) blockWhilst 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. | Procedure or surgery | Ultrasound Transversus Abdominis Plane (U-TAP) group |
| Ropivacainea solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block) | Drug | Laparoscopic Transversus Abdominis Plane (L-TAP) group, Ultrasound Transversus Abdominis Plane (U-TAP) group |
Primary outcome
Opioids consumption
Time frame: 24 hours from surgery
Opioid consumption measured in morphine milligram equivalents (MME) per day
4 secondary outcomes
Opioid consumption within the first 48 hours after the operation
Time frame: 48 hours from surgery
postoperative pain
Time frame: at 3, 6, 12, 24 hours from surgery
length of hospital stay
Time frame: during hospitalization,approximately 6 days
Time required to perform the (Transversus Abdominis Plane) TAP block
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Derived from this study: PubMed 37525414La Regina D, Popeskou SG, Saporito A, Gaffuri P, Tasciotti E, Dossi R, Christoforidis D, Mongelli F. Laparoscopic versus ultrasound-guided transversus abdominis plane block in colorectal surgery: a non-inferiority, multicentric randomized double-blinded clinical trial. Colorectal Dis. 2023 Sep;25(9):1921-1928. doi: 10.1111/codi.16689. Epub 2023 Jul 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide La Regina, MD study chair
Ente Ospedaliero Cantonale (EOC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic-assisted Transversus Abdominis Plane (TAP) block, ultrasound-assisted Transversus Abdominis Plane (TAP) block and Ropivacaine in people with Laparoscopic Colectomy and Pain, Postoperative, run by Davide La Regina at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioids consumption (time frame: 24 hours from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.