Laparoscopic Colon SurgeryPhase 4NCT01418144
Effect of Transversus Abdominis Plane (TAP) Block After Laparoscopic Colon Surgery
A Phase 4 study testing Transversus abdominis plane (TAP) block in people with Laparoscopic Colon Surgery, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after laparoscopic surgery on colon. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Colon Surgery
- What is being tested?
- Transversus abdominis plane (TAP) block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Jul 2013
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80
- BMI 18 - 40
- ASA 1 - 3
- Written consent
- Can cooperate
Who cannot join
- Mb Chron and Collitis Ulcerosa
- Drug and alcohol abuse
- Pregnancy
- Consumption of opioids
- Drug allergy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Herlev University Hospital, Department of anaesthesia
Copenhagen, Herlev, 2730
About this study
Official title: Effect of Transversus Abdominis Plane (TAP) Block as Postoperative Pain Management After Laparoscopic Colon Surgery
The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after laparoscopic surgery on colon.
- Conditions
- Laparoscopic Colon Surgery
- Being tested
- Transversus abdominis plane (TAP) block, Placebo TAP block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane (TAP) blockProcedure or surgery
Also called Naropin
Bilateral UL-guided TAP block with 20 ml of ropivacaine 0,5%
Placebo TAP blockProcedure or surgery
Also called Placebo block
Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane
| Study group | Role | What they receive |
|---|---|---|
| Transversus abdominis plane (TAP) block | Experimental | Transversus abdominis plane (TAP) block with ropivacaine Receives: Procedure: Transversus abdominis plane (TAP) block |
| Block with saline | Placebo comparator | Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane Receives: Procedure: Placebo TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during cough
VAS-pain score
Measured: 6 hours
Secondary outcomes (3)
Pain during rest
VAS-pain score at rest
Measured: 1,2,4,6,12 and 24 hours
Total opioid consumption
Opioid consumption via PCA-pump.
Measured: 0-24 hours
Postoperative nausea and vomiting
Nausea score 0-3 No. of vomits
Measured: 1,2,4,6,12,18 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startAug 2010
- Primary completionFeb 2013
- Study completionJul 2013
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 Colon SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418144
- Sponsor's protocol ID
- SM1-HT-2010
- Status last verified
- Aug 2013
- First submitted
- 9 Jun 2011
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Torup H, Hansen EG, Bogeskov M, Rosenberg J, Mitchell AU, Petersen PL, Mathiesen O, Dahl JB, Moller AM. Transversus abdominis plane block after laparoscopic colonic resection in cancer patients: A randomised clinical trial. Eur J Anaesthesiol. 2016 Oct;33(10):725-30. doi: 10.1097/EJA.0000000000000510.
PubMed 27487909
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transversus Abdominis Plane (TAP) Block as Postoperative Pain Management After Laparoscopic Colon Surgery
- ClinicalTrials.gov ID
- NCT01418144
- Acronym / sponsor ID
- SM1-HT-2010
- Conditions
- Laparoscopic Colon Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Aug 2011 (estimated)
- 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 investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after laparoscopic surgery on colon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus abdominis plane (TAP) block | Experimental | Procedure: Transversus abdominis plane (TAP) blockTransversus abdominis plane (TAP) block with ropivacaine |
| Block with saline | Placebo comparator | Procedure: Placebo TAP blockBilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 80
- BMI 18 - 40
- ASA 1 - 3
- Written consent
- Can cooperate
Key exclusion criteria (5 listed)
- Mb Chron and Collitis Ulcerosa
- Drug and alcohol abuse
- Pregnancy
- Consumption of opioids
- Drug allergy
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 |
|---|---|---|
| Transversus abdominis plane (TAP) blockAlso: NaropinBilateral UL-guided TAP block with 20 ml of ropivacaine 0,5% | Procedure or surgery | Transversus abdominis plane (TAP) block |
| Placebo TAP blockAlso: Placebo blockBilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane | Procedure or surgery | Block with saline |
Primary outcome
Pain during cough
Time frame: 6 hours
VAS-pain score
3 secondary outcomes
Pain during rest
Time frame: 1,2,4,6,12 and 24 hours
Total opioid consumption
Time frame: 0-24 hours
Postoperative nausea and vomiting
Time frame: 1,2,4,6,12,18 and 24 hours
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 22 Aug 2013.
- Derived from this study: PubMed 27487909Torup H, Hansen EG, Bogeskov M, Rosenberg J, Mitchell AU, Petersen PL, Mathiesen O, Dahl JB, Moller AM. Transversus abdominis plane block after laparoscopic colonic resection in cancer patients: A randomised clinical trial. Eur J Anaesthesiol. 2016 Oct;33(10):725-30. doi: 10.1097/EJA.0000000000000510.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transversus abdominis plane (TAP) block in people with Laparoscopic Colon Surgery, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 5 inclusion and 5 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 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain during cough (time frame: 6 hours). 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 NCT01418144, 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 22 Aug 2013.