HysterectomyPhase 4TAP-blockNCT01504386
Transversus Abdominis Plane Block After Robot-assisted Laparocopic Hysterectomy
A Phase 4 study testing TAP block in people with Hysterectomy, 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 robot-assisted laparoscopic hysterecomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- TAP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- BMI 17-40
- Written consent
- Can cooperate
Who cannot join
- Drug and alcohol abuse
- Consumption of opioids
- Drug allergy
- Infection at insertion point of needle
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Herlev Univerity Hospital, Department of Anaesthesia
Herlev, 2730
About this study
Official title: Effekt of Transversus Abdominis Plane (TAP) Block After Robot-assisted Laparocopic Hysterectomy
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 robot-assisted laparoscopic hysterecomy.
- Conditions
- Hysterectomy
- Being tested
- TAP block, Placebo TAP block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
Also called Naropin 0.5%
Bilateral UL-guided TAP block with 20 ml of ropivacaine 0.5 %
Placebo TAP blockProcedure or surgery
Also called Saline 0.9%
Bilateral placement of 20 ml of saline 0.9 % in the transversus abdominis plane
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Experimental | TAP block with ropivacaine Receives: Procedure: TAP block |
| Placebo TAP block | Placebo comparator | Sham block with saline Receives: Procedure: Placebo TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Opioid consumption via PCA-pump
Measured: 0-24 hours
Secondary outcomes (2)
Pain during rest and cough
VAS-pain score at rest and at cough
Measured: 1,2,4,8,18 and 24 hours
Postoperative nausea and vomiting
Nausea score 0-3 No. of vomits
Measured: 1,2,4,8,18 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 posted5 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionJul 2013
Why it stopped: Due to local restructering, further recruting was not possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik Torup, MD, Principal investigator, Herlev University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504386
- Sponsor's protocol ID
- SM1-HT-2011
- Acronym
- TAP-block
- Status last verified
- Aug 2013
- First submitted
- 30 Dec 2011
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
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
- Effekt of Transversus Abdominis Plane (TAP) Block After Robot-assisted Laparocopic Hysterectomy
- ClinicalTrials.gov ID
- NCT01504386
- Acronym / sponsor ID
- TAP-block / SM1-HT-2011
- Conditions
- Hysterectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to local restructering, further recruting was not possible
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Jan 2012 (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 robot-assisted laparoscopic hysterecomy.
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 |
|---|---|---|
| TAP block | Experimental | Procedure: TAP blockTAP block with ropivacaine |
| Placebo TAP block | Placebo comparator | Procedure: Placebo TAP blockSham block with saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80
- BMI 17-40
- Written consent
- Can cooperate
Key exclusion criteria (4 listed)
- Drug and alcohol abuse
- Consumption of opioids
- Drug allergy
- Infection at insertion point of needle
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 |
|---|---|---|
| TAP blockAlso: Naropin 0.5%Bilateral UL-guided TAP block with 20 ml of ropivacaine 0.5 % | Procedure or surgery | TAP block |
| Placebo TAP blockAlso: Saline 0.9%Bilateral placement of 20 ml of saline 0.9 % in the transversus abdominis plane | Procedure or surgery | Placebo TAP block |
Primary outcome
Total opioid consumption
Time frame: 0-24 hours
Opioid consumption via PCA-pump
2 secondary outcomes
Pain during rest and cough
Time frame: 1,2,4,8,18 and 24 hours
Postoperative nausea and vomiting
Time frame: 1,2,4,8,18 and 24 hours
Results and safety
The study was stopped early (reason given: Due to local restructering, further recruting was not possible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2013.
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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.
Henrik Torup, MD principal investigator
Herlev University Hospital, Copenhagen
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 TAP block in people with Hysterectomy, 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 4 inclusion and 4 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: stopped early, 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 was stopped early (reason given: Due to local restructering, further recruting was not possible). Results are not available in the source record.
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?
Total opioid consumption (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.