PainPhase 1NCT00682136
Analgesic Efficacy of Local Anesthetic Transversus Abdominis Plane (TAP) Blocks in Abdominal Surgery
A Phase 1 study testing US-Guided Ropivacaine TAP Block in people with Pain, run by Hunter Colorectal Research at 4 sites in Australia.
Trial summary
The aim of the study is to establish the efficacy of local anaesthetic TAP (transversus abdominis plane) blocks in providing pain relief in the first 24hrs following open or laparoscopic elective abdominal colorectal operations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- US-Guided Ropivacaine TAP Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 4 sitesAustralia
- Study dates
- Apr 2008to Dec 2009
- Phase
- Phase 1
- 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
- All patients aged 18 and over undergoing elective open or laparoscopic colorectal surgery performed by the participating surgeons within the study period will be considered for the trial.
Who cannot join
- History of adverse reaction to Ropivicaine or similar drug.
- Inability or refusal to give consent
- Coagulopathic
- Severe renal impairment
- Aged <18 years
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
John Hunter Hospital
New Lambton, New South Wales, 2305
Newcastle Private Hospital
New Lambton, New South Wales, 2305
Private Medical Suites
New Lambton, New South Wales, 2305
Mater Misericordiae Hospital
Waratah, New South Wales, 2298
About this study
Official title: Efficacy of Local Anesthetic TAP Blocks in Providing Pain Relief Following Laparoscopic and Open Abdominal Surgery
The aim of the study is to establish the efficacy of local anaesthetic TAP (transversus abdominis plane) blocks in providing pain relief in the first 24hrs following open or laparoscopic elective abdominal colorectal operations.
TAP blocks involve the injection of local aesthetic (ropivicaine) into the transversus abdominis plane in the abdominal wall. This injection takes place after induction of anaesthesia, but before the commencement of surgery. TAP blocks have been proposed as a potential safer alternative to epidural anaesthesia. The blocks have been extensively used in the Hunter New England system over the last 18 months. As yet there is no clear evidence for there efficacy, hence the need for this trial.
This trial would establish the efficacy of this practice. If the technique proves effective it could be widely used and provide a simpler method of managing post operative pain.
- Conditions
- Pain
- Being tested
- US-Guided Ropivacaine TAP Block
- Keywords
- postoperative analgesia, abdominal surgery, ropivacaine, local anaesthesia, tap block, pain management
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-Guided Ropivacaine TAP BlockProcedure or surgery
Also called TAP Block
Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Open Laparotomy Arm: All patients enrolled in the study who are undergoing elective open laparotomy surgery. Receives: Procedure: US-Guided Ropivacaine TAP Block |
| 2 | Active comparator | Laparoscopic Arm: All patients enrolled in the study who are undergoing elective laparoscopic abdominal surgery. Receives: Procedure: US-Guided Ropivacaine TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
mg/kg of morphine equivalent used by patients post operatively.
Measured: From operation until discharge.
Secondary outcomes (2)
Lung Function (spirometry), including FVC, FEV1 and PEFR
Measured: 24, 48 and 72 hours postoperatively
Visual Analogue Scale for pain at rest, deep breathing and coughing.
Measured: 24, 48 and 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter Colorectal Research
- Sponsor type
- University, hospital or other
- Investigators
- Brian Draganic, B.Med.,B.Med.Sci.(Hons),FRACS, Principal investigator, Hunter Colorectal ResearchStephen Smith, B.Med.,F.R.A.C.S., Principal investigator, Hunter Colorectal Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682136
- Sponsor's protocol ID
- TAPTRIAL
- Other IDs
- 08/02/20/3.02
- Status last verified
- Jun 2010
- First submitted
- 20 May 2008
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Local Anesthetic TAP Blocks in Providing Pain Relief Following Laparoscopic and Open Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00682136
- Acronym / sponsor ID
- TAPTRIAL
- Conditions
- Pain
- Keywords
- postoperative analgesia, abdominal surgery, ropivacaine, local anaesthesia, tap block, pain management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Hunter Colorectal ResearchUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 May 2008 (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 aim of the study is to establish the efficacy of local anaesthetic TAP (transversus abdominis plane) blocks in providing pain relief in the first 24hrs following open or laparoscopic elective abdominal colorectal operations.
TAP blocks involve the injection of local aesthetic (ropivicaine) into the transversus abdominis plane in the abdominal wall. This injection takes place after induction of anaesthesia, but before the commencement of surgery. TAP blocks have been proposed as a potential safer alternative to epidural anaesthesia. The blocks have been extensively used in the Hunter New England system over the last 18 months. As yet there is no clear evidence for there efficacy, hence the need for this trial.
This trial would establish the efficacy of this practice. If the technique proves effective it could be widely used and provide a simpler method of managing post operative pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: US-Guided Ropivacaine TAP BlockOpen Laparotomy Arm: All patients enrolled in the study who are undergoing elective open laparotomy surgery. |
| 2 | Active comparator | Procedure: US-Guided Ropivacaine TAP BlockLaparoscopic Arm: All patients enrolled in the study who are undergoing elective laparoscopic abdominal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged 18 and over undergoing elective open or laparoscopic colorectal surgery performed by the participating surgeons within the study period will be considered for the trial.
Key exclusion criteria (5 listed)
- History of adverse reaction to Ropivicaine or similar drug.
- Inability or refusal to give consent
- Coagulopathic
- Severe renal impairment
- Aged <18 years
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 |
|---|---|---|
| US-Guided Ropivacaine TAP BlockAlso: TAP BlockBilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound. | Procedure or surgery | 1, 2 |
Primary outcome
mg/kg of morphine equivalent used by patients post operatively.
Time frame: From operation until discharge.
2 secondary outcomes
Lung Function (spirometry), including FVC, FEV1 and PEFR
Time frame: 24, 48 and 72 hours postoperatively
Visual Analogue Scale for pain at rest, deep breathing and coughing.
Time frame: 24, 48 and 72 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 3 Jun 2010.
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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.
Brian Draganic, B.Med.,B.Med.Sci.(Hons),FRACS principal investigator
Hunter Colorectal Research
Stephen Smith, B.Med.,F.R.A.C.S. principal investigator
Hunter Colorectal Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing US-Guided Ropivacaine TAP Block in people with Pain, run by Hunter Colorectal Research at 4 sites in Australia.
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 5 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 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
mg/kg of morphine equivalent used by patients post operatively. (time frame: From operation until discharge.). 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 3 Jun 2010.