Postoperative PainEarly Phase 1NCT00819962
Perioperative Analgesia Using Ultrasound (US) Guided Transversus Abdominis Plane (TAP) Block
A Early Phase 1 study testing Bupivacaine and TAP in people with Postoperative Pain, run by King Saud University at 2 sites in Saudi Arabia.
Trial summary
Perioperative analgesia using US guided TAP block Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine and TAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Sep 2014to Dec 2016
- Phase
- Early 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult undergoing laparoscopic cholecystectomy
Who cannot join
- history of cardiorespiratory disease
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
A Dawlatly
Riyadh, Riyadh Region
a dawlatly a abdelaz, 00966 503261042, dawlatly@ksu.edu.sa
a a daw, md
- Recruiting
A Dawlatly
Riyadh, Riyadh Region
a dawlatly a abdelaz
a a daw, md
About this study
Perioperative analgesia using US guided TAP block
Read the detailed description
Perioperative analgesia using US guided TAP block
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine, TAP
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Local anesthetic
TAPOther
| Study group | Role | What they receive |
|---|---|---|
| TAP | Other | ksu Receives: Drug: Bupivacaine; Other: TAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Measured: after US TAP block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.Eldawlatly, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819962
- Sponsor's protocol ID
- 08-652
- Status last verified
- Nov 2014
- First submitted
- 6 Jan 2009
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesia Using Ultrasound (US) Guided Transversus Abdominis Plane (TAP) Block
- ClinicalTrials.gov ID
- NCT00819962
- Acronym / sponsor ID
- 08-652
- Conditions
- Postoperative Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Jan 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.
Perioperative analgesia using US guided TAP block
Detailed description
Perioperative analgesia using US guided TAP block
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAP | Other | Drug: Bupivacaine, Other: TAPksu |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult undergoing laparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- history of cardiorespiratory disease
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 |
|---|---|---|
| BupivacaineLocal anesthetic | Drug | TAP |
| TAP | Other | TAP |
Primary outcome
Pain relief
Time frame: after US TAP block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bupivacaine and TAP in people with Postoperative Pain, run by King Saud University at 2 sites in Saudi Arabia.
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: status not confirmed, as of the sponsor's last update on 15 Sep 2015. 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 Saudi Arabia. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdelazeem a dawlat, md (4692007, dawlatly@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: after US TAP block). 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 15 Sep 2015.