TAP and RS BlockPhase 2NCT03536741
Role of TAP and RS Block in Reduction of Postoperative Pain for Gynecological Surgical Laparoscopic Procedures
A Phase 2 study testing TAP block and RS block + General Intravenous Anesthestic and General Intravenous Anesthetic in people with TAP and RS Block, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The present study aims to demonstrate the effectiveness of loco-regional wall anesthesia of the transversus abdominis plane block (TAP block) and the rectus sheath block (RS block), compared to intravenous analgesia, in terms of pain reduction, postoperative analgesic drugs consumption, patient satisfaction and… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- TAP and RS Block
- What is being tested?
- TAP block and RS block + General Intravenous Anesthestic and General Intravenous Anesthetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2017to 12 Jul 2018
- Phase
- Phase 2
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing benign laparoscopic gynecological surgery
- age between 18 and 75 years
- BMI >18 e <35
- ECOG Performance Status 0-1
Who cannot join
- age < 18 or > 75 years
- BMI <18 or > 35
- ECOG Performance Status >1
- Allergy to local anesthetics
- Allergy to NSAIDs
- Chronic kidney failure > II class
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- Systemic neoplastic disease actual or previous
- Actual pregnancy
- Active or recent pelvic inflammation
- Persistent coagulopathy
- Previous opioids consumption for chronic pain
- Neurological or cognitive disorders
- Conversion from laparoscopic to open surgery
- Onset of intraoperative complications
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Campus Bio-medico
Roma, RM, 00128
Corrado Terranova, 06225411203, c.terranova@unicampus.it
About this study
Official title: The Role of Transversus Abdominis Plane Block and Rectus Sheath Block in Reduction of Postoperative Pain for Gynecological Benign Surgical Laparoscopic Procedures: a Randomized Controlled Trial
The present study aims to demonstrate the effectiveness of loco-regional wall anesthesia of the transversus abdominis plane block (TAP block) and the rectus sheath block (RS block), compared to intravenous analgesia, in terms of pain reduction, postoperative analgesic drugs consumption, patient satisfaction and decrease of LOS (length of stay), in patients undergoing benign gynecological laparoscopic surgical procedures.
- Conditions
- TAP and RS Block
- Being tested
- TAP block and RS block + General Intravenous Anesthestic, General Intravenous Anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block and RS block + General Intravenous AnesthesticProcedure or surgery
transversus abdominis plane block and rectus sheath block
General Intravenous AnestheticDrug
General Intravenous Anesthetic
| Study group | Role | What they receive |
|---|---|---|
| ALR | Experimental | Not described Receives: Procedure: TAP block and RS block + General Intravenous Anesthestic |
| EV | Active comparator | Not described Receives: Drug: General Intravenous Anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain in the first 72 hours after gynecological surgical procedures
postoperative pain in the first 72 hours after gynecological surgical procedures
Measured: postoperative pain in the first 72 hours after gynecological surgical procedures
analgesic consumption in the first 72 hours after gynecological surgical procedures
analgesic consumption in the first 72 hours after gynecological surgical procedures
Measured: analgesic consumption in the first 72 hours after gynecological surgical procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start12 Oct 2017
- Primary completion12 Jul 2018 (estimated)
- Study completion12 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAP and RS BlockStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corrado Terranova, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536741
- Sponsor's protocol ID
- GIN-TAP 2017
- Status last verified
- May 2018
- First submitted
- 9 Mar 2018
- Last updated
- 25 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Transversus Abdominis Plane Block and Rectus Sheath Block in Reduction of Postoperative Pain for Gynecological Benign Surgical Laparoscopic Procedures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03536741
- Acronym / sponsor ID
- GIN-TAP 2017
- Conditions
- TAP and RS Block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 12 Jul 2018 (estimated)
- Study completion
- 12 Jul 2018 (estimated)
- First posted
- 25 May 2018 (actual)
- 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 present study aims to demonstrate the effectiveness of loco-regional wall anesthesia of the transversus abdominis plane block (TAP block) and the rectus sheath block (RS block), compared to intravenous analgesia, in terms of pain reduction, postoperative analgesic drugs consumption, patient satisfaction and decrease of LOS (length of stay), in patients undergoing benign gynecological laparoscopic surgical procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALR | Experimental | Procedure: TAP block and RS block + General Intravenous Anesthestic |
| EV | Active comparator | Drug: General Intravenous Anesthetic |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing benign laparoscopic gynecological surgery
- age between 18 and 75 years
- BMI >18 e <35
- ECOG Performance Status 0-1
Key exclusion criteria (14 listed)
- age < 18 or > 75 years
- BMI <18 or > 35
- ECOG Performance Status >1
- Allergy to local anesthetics
- Allergy to NSAIDs
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 |
|---|---|---|
| TAP block and RS block + General Intravenous Anesthestictransversus abdominis plane block and rectus sheath block | Procedure or surgery | ALR |
| General Intravenous AnestheticGeneral Intravenous Anesthetic | Drug | EV |
Primary outcome
postoperative pain in the first 72 hours after gynecological surgical procedures
Time frame: postoperative pain in the first 72 hours after gynecological surgical procedures
postoperative pain in the first 72 hours after gynecological surgical procedures
analgesic consumption in the first 72 hours after gynecological surgical procedures
Time frame: analgesic consumption in the first 72 hours after gynecological surgical procedures
analgesic consumption in the first 72 hours after gynecological surgical procedures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAP block and RS block + General Intravenous Anesthestic and General Intravenous Anesthetic in people with TAP and RS Block, run by Campus Bio-Medico University at 1 site in Italy.
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 4 inclusion and 14 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 25 May 2018. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain in the first 72 hours after gynecological surgical procedures (time frame: postoperative pain in the first 72 hours after gynecological surgical procedures). The study lists 2 primary outcomes in all. 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 25 May 2018.