Pain TreatmentNCT01760161
Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery
A study testing Ropivacaine and Isotonic potassium chloride in people with Pain Treatment and Robotic Assisted Laparoscopic Surgery, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Treatment, Robotic Assisted Laparoscopic Surgery, Bilateral Dual Transversus Abdominis Plane Block
- What is being tested?
- Ropivacaine and Isotonic potassium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Feb 2016
- 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 scheduled for robotic assisted laparoscopis surgery
- acceptance to participate
Who cannot join
- allergies to local analgetics
- daily use of strong opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind Study to Evaluate the Effect of Bilateral Dual Transversus Abdominis Plane Block on Postoperative Pain and Plasma Concentration of Ropivacaine After Robotic Assisted Laparoscopic Surgery
To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.
Read the detailed description
After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.
The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.
Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.
The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.
- Conditions
- Pain Treatment, Robotic Assisted Laparoscopic Surgery, Bilateral Dual Transversus Abdominis Plane Block
- Being tested
- Ropivacaine, Isotonic potassium chloride
- Keywords
- postoperative pain, opioid consumption, termanalgesia, plasmaropivacain level
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block
Isotonic potassium chlorideDrug
Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacain | Active comparator | Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block Receives: Drug: Ropivacaine |
| Isotonic potassium chloride | Placebo comparator | Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block. Receives: Drug: Isotonic potassium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-score on numerical rating scale
Measured: 4 hours after surgery
Secondary outcomes (3)
Administration of opioids
Measured: The first 24 hours after surgery.
Pain-score on numerical rating scale
Measured: 8 hours after surgery
Pain-score on numerical rating scale
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startApr 2014
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Why it stopped: No signal on pain-score
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain TreatmentStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nils Bjerregaard, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760161
- Sponsor's protocol ID
- 20120042
- Status last verified
- May 2015
- First submitted
- 19 Dec 2012
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind Study to Evaluate the Effect of Bilateral Dual Transversus Abdominis Plane Block on Postoperative Pain and Plasma Concentration of Ropivacaine After Robotic Assisted Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01760161
- Acronym / sponsor ID
- 20120042
- Conditions
- Pain Treatment, Robotic Assisted Laparoscopic Surgery, Bilateral Dual Transversus Abdominis Plane Block
- Keywords
- postoperative pain, opioid consumption, termanalgesia, plasmaropivacain level
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No signal on pain-score
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 4 Jan 2013 (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.
To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.
Detailed description
After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.
The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.
Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.
The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.
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 |
|---|---|---|
| Ropivacain | Active comparator | Drug: RopivacaineRopicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block |
| Isotonic potassium chloride | Placebo comparator | Drug: Isotonic potassium chlorideIsotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block. |
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 scheduled for robotic assisted laparoscopis surgery
- acceptance to participate
Key exclusion criteria (2 listed)
- allergies to local analgetics
- daily use of strong opioids
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 |
|---|---|---|
| RopivacaineRopicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block | Drug | Ropivacain |
| Isotonic potassium chlorideIsotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block. | Drug | Isotonic potassium chloride |
Primary outcome
Pain-score on numerical rating scale
Time frame: 4 hours after surgery
3 secondary outcomes
Administration of opioids
Time frame: The first 24 hours after surgery.
Pain-score on numerical rating scale
Time frame: 8 hours after surgery
Pain-score on numerical rating scale
Time frame: 24 hours after surgery
Results and safety
The study was stopped early (reason given: No signal on pain-score). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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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 study testing Ropivacaine and Isotonic potassium chloride in people with Pain Treatment and Robotic Assisted Laparoscopic Surgery, run by Aalborg 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 2 inclusion and 2 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 12 May 2015. 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 was stopped early (reason given: No signal on pain-score). 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?
Pain-score on numerical rating scale (time frame: 4 hours after surgery). 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 12 May 2015.