Pain, PostoperativeNCT01760174
Comparing the Effect of TAP-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery
A study testing Ropivacaine bolus in transversus abdominis plane catheter and Bupivacain-infusion in epidural catheter in people with Pain, Postoperative, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This study compares the effect on postoperative pain of bolus administration of ropivacaine in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural catheters following open gynecologic surgery.The study is double blind. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ropivacaine bolus in transversus abdominis plane catheter and Bupivacain-infusion in epidural catheter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Feb 2017
- 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 open gynecologic 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 Randomized Double Blind Trial Comparing the Effect of Transversus Abdominal Plane-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery
This study compares the effect on postoperative pain of bolus administration of ropivacaine in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural catheters following open gynecologic surgery.The study is double blind. The hypothesis is that the effect of the two modes of pain treatment are equal.
Read the detailed description
Patients for open gynecologic surgery will all receive both an epidural catheter and bilateral transversus abdominis plane (:TAP) catheters. After randomization in to two groups the patients receive either 1) intermittent boluses of ropivacaine in the TAP-catheters and isotonic potassium chloride-infusion i the epidural catheters or 2) intermittent isotonic potassium chloride-boluses i the TAP-catheters and bupivacain-infusion in the epidural catheters.
The investigators record pain-score and consumption of opioids in the first 24 hours postoperatively as well as thermoanalgesia at dermatome-levels th10-th12.
The investigators assume that the effect on postoperative pain after open gynecologic surgery is equal in the two groups.
- Conditions
- Pain, Postoperative
- Being tested
- Ropivacaine bolus in transversus abdominis plane catheter, Bupivacain-infusion in epidural catheter
- Keywords
- Transversus abdominis plane catheter
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine bolus in transversus abdominis plane catheterDrug
Ropivacaine 7,5 mg/ml, 10-25 ml in each catheter, depending on patient weight, the total dose of ropivacaine is kept less than 3 mg/kg for every bolus. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours.
In the epidural catheter a bolus of 8 ml isotonic potassium chloride is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours.
Bupivacain-infusion in epidural catheterDrug
Isotonic potassium chloride, 10-25 ml in each transversus abdominis catheter, depending on patient weight. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours.
In the epidural catheter a bolus of 8 ml bupivacaine 2,5 mg/ml is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Bupivacain-infusion in epidural catheter | Active comparator | Bupivacain-infusion in epidural catheter and intermittent isotonic potassium chloride bolus in transversus abdominis plane catheter. Receives: Drug: Bupivacain-infusion in epidural catheter |
| Ropivacaine bolus in transversus abdominis plane catheter | Active comparator | Intermittent ropivacaine bolus in bilateral transversus abdominis plane catheter and isotonic potassium chloride infusion in epidural catheter. Receives: Drug: Ropivacaine bolus in transversus abdominis plane catheter |
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 first bolus in tranversus abdominis catheters
Secondary outcomes (3)
Administration of opioids
Measured: The first 24 hours after surgery.
Pain-score on numerical rating scale
Measured: 8 hours after first bolus in tranversus abdominis catheters
Pain-score on numerical rating scale
Measured: 24 hours after first bolus in tranversus abdominis catheters
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 startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: Because of logistic and practical reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Nils Bjerregaard, Aalborg University Hospital
- Investigators
- Nils F Bjerregaard, M.D., Principal investigator, Aalborg University HospitalBodil S Rasmussen, M.D. + PhD, Study director, Aalborg SygehusLone Nikolajsen, M.D, PhD, Study chair, Aarhus University HospitalThomas F Bendtsen, MD, PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760174
- Sponsor's protocol ID
- N-20120041
- Status last verified
- May 2015
- First submitted
- 26 Jul 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 Randomized Double Blind Trial Comparing the Effect of Transversus Abdominal Plane-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT01760174
- Acronym / sponsor ID
- N-20120041
- Conditions
- Pain, Postoperative
- Keywords
- Transversus abdominis plane catheter
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of logistic and practical reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (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.
This study compares the effect on postoperative pain of bolus administration of ropivacaine in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural catheters following open gynecologic surgery.The study is double blind. The hypothesis is that the effect of the two modes of pain treatment are equal.
Detailed description
Patients for open gynecologic surgery will all receive both an epidural catheter and bilateral transversus abdominis plane (:TAP) catheters. After randomization in to two groups the patients receive either 1) intermittent boluses of ropivacaine in the TAP-catheters and isotonic potassium chloride-infusion i the epidural catheters or 2) intermittent isotonic potassium chloride-boluses i the TAP-catheters and bupivacain-infusion in the epidural catheters.
The investigators record pain-score and consumption of opioids in the first 24 hours postoperatively as well as thermoanalgesia at dermatome-levels th10-th12.
The investigators assume that the effect on postoperative pain after open gynecologic surgery is equal in the two groups.
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 |
|---|---|---|
| Bupivacain-infusion in epidural catheter | Active comparator | Drug: Bupivacain-infusion in epidural catheterBupivacain-infusion in epidural catheter and intermittent isotonic potassium chloride bolus in transversus abdominis plane catheter. |
| Ropivacaine bolus in transversus abdominis plane catheter | Active comparator | Drug: Ropivacaine bolus in transversus abdominis plane catheterIntermittent ropivacaine bolus in bilateral transversus abdominis plane catheter and isotonic potassium chloride infusion in epidural catheter. |
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 open gynecologic 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 |
|---|---|---|
| Ropivacaine bolus in transversus abdominis plane catheterRopivacaine 7,5 mg/ml, 10-25 ml in each catheter, depending on patient weight, the total dose of ropivacaine is kept less than 3 mg/kg for every bolus. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours. In the epidural catheter a bolus of 8 ml isotonic potassium chloride is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours. | Drug | Ropivacaine bolus in transversus abdominis plane catheter |
| Bupivacain-infusion in epidural catheterIsotonic potassium chloride, 10-25 ml in each transversus abdominis catheter, depending on patient weight. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours. In the epidural catheter a bolus of 8 ml bupivacaine 2,5 mg/ml is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours | Drug | Bupivacain-infusion in epidural catheter |
Primary outcome
Pain-score on numerical rating scale
Time frame: 4 hours after first bolus in tranversus abdominis catheters
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 first bolus in tranversus abdominis catheters
Pain-score on numerical rating scale
Time frame: 24 hours after first bolus in tranversus abdominis catheters
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Nils F Bjerregaard, M.D. principal investigator
Aalborg University Hospital
Bodil S Rasmussen, M.D. + PhD study director
Aalborg Sygehus
Lone Nikolajsen, M.D, PhD study chair
Aarhus University Hospital
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 bolus in transversus abdominis plane catheter and Bupivacain-infusion in epidural catheter in people with Pain, Postoperative, 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: withdrawn, 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. 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 withdrawn before enrolling participants, so there are no results.
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 first bolus in tranversus abdominis catheters). 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.