Postoperative PainPhase 4NCT01577940
Method Study: Bilateral TAP Block With 24 Hours Infusion
A Phase 4 study testing Infusion of ropivacaine and Infusion of saline in people with Postoperative Pain, run by Glostrup University Hospital, Copenhagen at 2 sites in Denmark.
Trial summary
The purpose of this method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Infusion of ropivacaine and Infusion of saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2011to May 2012
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 30 years
- written consent
- ASA 1
- BMI between 18 and 25
- males
Who cannot join
- unable to communicate in Danish
- relevant drug allergy
- alcohol or/and drug abuse
- daily intake of prescription pain medication the last 4 weeks
- pain medication in the last 48 hours
- previously operated abdominal
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
HOC, anesthesiology, Rigshospitalet
Copenhagen, 2100
HovedOrtoCentret, Rigshospitalet
Copenhagen, 2100
About this study
Official title: Method Study of Bilateral Transversus Abdominis Plane (TAP) Block With 24 Hours Infusion. Extent of Sensory Block, Analgetic Effect and Lung Function in Healthy Volunteers
The purpose of this method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function.
- Conditions
- Postoperative Pain
- Being tested
- Infusion of ropivacaine, Infusion of saline
- Keywords
- Transversus abdominis plane block, postoperative pain, Postoperative pain management
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of ropivacaineProcedure or surgery
TAP block with ropivacaine 20 ml 0,5%. Catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours on one side of the abdomen.
Infusion of salineProcedure or surgery
TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Infusion of local anesthetic | Experimental | TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours. Receives: Procedure: Infusion of ropivacaine |
| Infusion of saline | Placebo comparator | TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours. Receives: Procedure: Infusion of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements
Extent of sensory block using pinprick and ice
Measured: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Secondary outcomes (4)
Heat pain detection threshold (abdomen)
Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.
Measured: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Heat pain detection threshold (dominant forearm)
Gradually heating of the skin from 32 to 52 degrees Celcius. The participant indicates the temperature where the stimulus is painful.
Measured: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Long Thermal stimulation (abdomen)
Heating of the skin, 45 degrees Celsius 1 minute. The participant indicates pain scores on a Visuel Analog Scale from 0 (no pain) to 100 (worst imaginable)
Measured: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Lung function
Inspiratory and expiratory force
Measured: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
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 Postoperative PainStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pernille Lykke Petersen, Glostrup University Hospital, Copenhagen
- Investigators
- Pernille L Petersen, MD, Principal investigator, HOC, anesthesiology, Rigshospitalet, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577940
- Sponsor's protocol ID
- SM1-PLP-11
- Other IDs
- 2011-005118-13
- Status last verified
- May 2012
- First submitted
- 21 Nov 2011
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Petersen PL, Hilsted KL, Dahl JB, Mathiesen O. Bilateral transversus abdominis plane (TAP) block with 24 hours ropivacaine infusion via TAP catheters: A randomized trial in healthy volunteers. BMC Anesthesiol. 2013 Oct 10;13(1):30. doi: 10.1186/1471-2253-13-30.
PubMed 24106815
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method Study of Bilateral Transversus Abdominis Plane (TAP) Block With 24 Hours Infusion. Extent of Sensory Block, Analgetic Effect and Lung Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01577940
- Acronym / sponsor ID
- SM1-PLP-11
- Conditions
- Postoperative Pain
- Keywords
- Transversus abdominis plane block, postoperative pain, Postoperative pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Apr 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 method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infusion of local anesthetic | Experimental | Procedure: Infusion of ropivacaineTAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours. |
| Infusion of saline | Placebo comparator | Procedure: Infusion of salineTAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age between 18 and 30 years
- written consent
- ASA 1
- BMI between 18 and 25
- males
Key exclusion criteria (6 listed)
- unable to communicate in Danish
- relevant drug allergy
- alcohol or/and drug abuse
- daily intake of prescription pain medication the last 4 weeks
- pain medication in the last 48 hours
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 |
|---|---|---|
| Infusion of ropivacaineTAP block with ropivacaine 20 ml 0,5%. Catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours on one side of the abdomen. | Procedure or surgery | Infusion of local anesthetic |
| Infusion of salineTAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours. | Procedure or surgery | Infusion of saline |
Primary outcome
Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements
Time frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Extent of sensory block using pinprick and ice
4 secondary outcomes
Heat pain detection threshold (abdomen)
Time frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Heat pain detection threshold (dominant forearm)
Time frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Long Thermal stimulation (abdomen)
Time frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
Lung function
Time frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block
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 4 May 2012.
- Derived from this study: PubMed 24106815Petersen PL, Hilsted KL, Dahl JB, Mathiesen O. Bilateral transversus abdominis plane (TAP) block with 24 hours ropivacaine infusion via TAP catheters: A randomized trial in healthy volunteers. BMC Anesthesiol. 2013 Oct 10;13(1):30. doi: 10.1186/1471-2253-13-30.
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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.
Pernille L Petersen, MD principal investigator
HOC, anesthesiology, Rigshospitalet, Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infusion of ropivacaine and Infusion of saline in people with Postoperative Pain, run by Glostrup University Hospital, Copenhagen at 2 sites 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 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 4 May 2012. 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 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?
Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements (time frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block). 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 NCT01577940, 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 4 May 2012.