Postoperative PainNCT01040234
Bilateral Dual TAP Block: Description of a Novel Four-point Approach
An observational study of Postoperative Pain, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
A prospective study of 30 patients with severe postoperative pain following abdominal surgery, in which the dual TAP block technique has been used successfully to achieve pain relief. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bilateral dual TAP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to Jan 2010
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with postoperative pain following abdominal surgery that do not respond to moderate doses of opioid analgesics or patients with failed epidurals
Who may be able to join
- Patients with pain VAS >5 following abdominal surgery, in which conventional pain treatment or epidural block is either ineffective or contraindicated
Who cannot join
- Hypersensitivity to local anaesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Bilateral Dual Transversus Abdominis Plane (BD-TAP) Block: Description of a Novel Four-point Ultrasound-guided TAP Block Approach
A prospective study of 30 patients with severe postoperative pain following abdominal surgery, in which the dual TAP block technique has been used successfully to achieve pain relief. A description of ultrasound technique, effectiveness, duration and potential side effects of the pain treatment, with possible recommendations for future use.
Read the detailed description
This prospective cohort study is designed to describe a novel ultrasound-guided bilateral dual transversus abdominis plane (BD-TAP) block and to evaluate the postoperative analgesic efficacy in a selection of patients having undergone major abdominal surgery under general anaesthesia where neuraxial anaesthesia and/or intravenous administration of analgesics had failed or was unwanted by the patient, or if the placement of an epidural catheter was deemed impossible by the anaesthetist in charge. 30 consecutive patients planned for the study. BD-TAP to be performed bilaterally with a high frequency linear ultrasound probe, with bupivacaine. Success rate, decline in VAS score, postoperative demand of opioids and block performance time to be recorded.
- Conditions
- Postoperative Pain
- Being tested
- Bilateral dual TAP block
- Keywords
- postoperative pain, abdominal surgery, bilateral dual TAP block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral dual TAP blockProcedure or surgery
Also called Marcain, TAP block
Bupivacaine 2.5 mg/ml 15 ml per injection. 4 injections per patient according to dual TAP block procedure
| Study group | Role | What they receive |
|---|---|---|
| Active pain treatment | Bilateral dual TAP block Receives: Procedure: Bilateral dual TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS after the intervention compared to pre-intervention VAS
Measured: 10-20 minutes after intervention
Secondary outcomes (1)
Pain medication required following intervention
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Jensen, MD, BBA, Bispebjerg Hospital
- Investigators
- Jens N Børglum, MD, PhD, Principal investigator, Dept Z, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040234
- Sponsor's protocol ID
- BBH_Z-Regional-001
- Status last verified
- Oct 2015
- First submitted
- 17 Dec 2009
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Bilateral Dual Transversus Abdominis Plane (BD-TAP) Block: Description of a Novel Four-point Ultrasound-guided TAP Block Approach
- ClinicalTrials.gov ID
- NCT01040234
- Acronym / sponsor ID
- BBH_Z-Regional-001
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, abdominal surgery, bilateral dual TAP block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 29 Dec 2009 (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 study of 30 patients with severe postoperative pain following abdominal surgery, in which the dual TAP block technique has been used successfully to achieve pain relief. A description of ultrasound technique, effectiveness, duration and potential side effects of the pain treatment, with possible recommendations for future use.
Detailed description
This prospective cohort study is designed to describe a novel ultrasound-guided bilateral dual transversus abdominis plane (BD-TAP) block and to evaluate the postoperative analgesic efficacy in a selection of patients having undergone major abdominal surgery under general anaesthesia where neuraxial anaesthesia and/or intravenous administration of analgesics had failed or was unwanted by the patient, or if the placement of an epidural catheter was deemed impossible by the anaesthetist in charge. 30 consecutive patients planned for the study. BD-TAP to be performed bilaterally with a high frequency linear ultrasound probe, with bupivacaine. Success rate, decline in VAS score, postoperative demand of opioids and block performance time to be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active pain treatment | – | Procedure: Bilateral dual TAP blockBilateral dual TAP block |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with postoperative pain following abdominal surgery that do not respond to moderate doses of opioid analgesics or patients with failed epidurals
Key inclusion criteria (1 listed)
- Patients with pain VAS >5 following abdominal surgery, in which conventional pain treatment or epidural block is either ineffective or contraindicated
Key exclusion criteria (1 listed)
- Hypersensitivity to local anaesthetics
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 |
|---|---|---|
| Bilateral dual TAP blockAlso: Marcain, TAP blockBupivacaine 2.5 mg/ml 15 ml per injection. 4 injections per patient according to dual TAP block procedure | Procedure or surgery | Active pain treatment |
Primary outcome
Pain VAS after the intervention compared to pre-intervention VAS
Time frame: 10-20 minutes after intervention
1 secondary outcome
Pain medication required following intervention
Time frame: First 24 hours
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 23 Oct 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.
Jens N Børglum, MD, PhD principal investigator
Dept Z, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Bispebjerg 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 1 inclusion and 1 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 23 Oct 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 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?
Pain VAS after the intervention compared to pre-intervention VAS (time frame: 10-20 minutes after intervention). 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 23 Oct 2015.