Postoperative Pain and Postoperative Morphine Consumption After Abdominal HysterectomyNCT01743378
Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial
A study testing TAP Block Ropivacaine 0,75 % and TAP Block Saline 0,9 % in people with Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
A Prospective double-blinded randomized clinical trial to test the effect of transversus abdominis plane block on postoperative pain and opoid consumption after abdominal hysterectomy. Two groups of each 24 patients. All patients are given general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy
- What is being tested?
- TAP Block Ropivacaine 0,75 % and TAP Block Saline 0,9 %
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Jun 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assigned to elective abdominal hysterectomy
- Must be able to understand and speak danish
- Must be able to give verbal and written consent
Who cannot join
- Abuse of alcohol or medicin
- Daily treatment with opoids or glucocorticoids
- Allergy towards any kind of localanesthetic drug
- Intolerance toward morphine
- Psychiatric desease
- Age below 18
Trial locations and contacts
1 site in 1 country.
About this study
A Prospective double-blinded randomized clinical trial to test the effect of transversus abdominis plane block on postoperative pain and opoid consumption after abdominal hysterectomy.
Two groups of each 24 patients. All patients are given general anesthesia. The patients are randomized to have a ultrasound guided bilateral transversus abdominis plane block with either 2 x 20 ml 0,75 % ropivacaine or 2 x 20 ml of 0,9 saline. All patients are provided with a PCA for self administration of morphine.
Pain score on visual analog scale, nausea and vomiting are monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively as well as the total consumption of morphine after 24 hours.
- Being tested
- TAP Block Ropivacaine 0,75 %, TAP Block Saline 0,9 %
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP Block Ropivacaine 0,75 %Procedure or surgery
TAP Block Saline 0,9 %Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| TAP Block Ropivacaine 0,75 % | Experimental | Bilateral Transversus Abdominis Plane Block with 2 x 20 ml Ropivacaine 0,75 % Receives: Procedure: TAP Block Ropivacaine 0,75 % |
| TAP Block Saline 0,9 % | Placebo comparator | Bilateral Transversus abdominis plane block with 2 x 20 ml Saline 0,9 % Receives: Procedure: TAP Block Saline 0,9 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption during first 24 hours postoperatively
Measured: At 24 hours postoperatively
Secondary outcomes (1)
Postoperative pain by visual analog scale at
Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively by one of the investigators at rest, when coughing and when walking
Measured: Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startFeb 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain and Postoperative Morphine Consumption After Abdominal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Billy B Kristensen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743378
- Sponsor's protocol ID
- H-1-2010-068
- Status last verified
- Aug 2013
- First submitted
- 13 Nov 2012
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01743378
- Acronym / sponsor ID
- H-1-2010-068
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Dec 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.
A Prospective double-blinded randomized clinical trial to test the effect of transversus abdominis plane block on postoperative pain and opoid consumption after abdominal hysterectomy.
Two groups of each 24 patients. All patients are given general anesthesia. The patients are randomized to have a ultrasound guided bilateral transversus abdominis plane block with either 2 x 20 ml 0,75 % ropivacaine or 2 x 20 ml of 0,9 saline. All patients are provided with a PCA for self administration of morphine.
Pain score on visual analog scale, nausea and vomiting are monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively as well as the total consumption of morphine after 24 hours.
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 Ropivacaine 0,75 % | Experimental | Procedure: TAP Block Ropivacaine 0,75 %Bilateral Transversus Abdominis Plane Block with 2 x 20 ml Ropivacaine 0,75 % |
| TAP Block Saline 0,9 % | Placebo comparator | Procedure: TAP Block Saline 0,9 %Bilateral Transversus abdominis plane block with 2 x 20 ml Saline 0,9 % |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Assigned to elective abdominal hysterectomy
- Must be able to understand and speak danish
- Must be able to give verbal and written consent
Key exclusion criteria (6 listed)
- Abuse of alcohol or medicin
- Daily treatment with opoids or glucocorticoids
- Allergy towards any kind of localanesthetic drug
- Intolerance toward morphine
- Psychiatric desease
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 Block Ropivacaine 0,75 % | Procedure or surgery | TAP Block Ropivacaine 0,75 % |
| TAP Block Saline 0,9 % | Procedure or surgery | TAP Block Saline 0,9 % |
Primary outcome
Total morphine consumption during first 24 hours postoperatively
Time frame: At 24 hours postoperatively
1 secondary outcome
Postoperative pain by visual analog scale at
Time frame: Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively
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 30 Aug 2013.
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 study testing TAP Block Ropivacaine 0,75 % and TAP Block Saline 0,9 % in people with Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy, run by Hvidovre University Hospital 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 3 inclusion and 6 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 30 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.
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?
Total morphine consumption during first 24 hours postoperatively (time frame: At 24 hours postoperatively). 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 30 Aug 2013.