Postoperative PainPhase 4NCT01501565
Analgesic Efficacy of Ultrasound-guided Transverse-abdominal Plain Blockade in Urological Surgery
A Phase 4 study testing Postoperative transverse abdominal plain (TAP) blockade in people with Postoperative Pain, run by Fundacio Puigvert at 1 site in Spain.
Trial summary
The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12 and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP) and patients under conventional analgesia. Also the opioid consumption is assessed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Postoperative transverse abdominal plain (TAP) blockade
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2011to Nov 2012
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 yrs.
- Patients undergo laparoscopic urologic surgery
- Physical status ASA < 3
- Surgical procedure without complications
- Signed informed consent
Who cannot join
- Allergy to bupivacaine chlorhydrate
- Patients with chronic pain treatment
- Alcoholism
- Decompensated hepatic disease
- Coagulation disorders
- BMI > 35
- Patient involved in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.
The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12 and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP) and patients under conventional analgesia. Also the opioid consumption is assessed.
- Conditions
- Postoperative Pain
- Being tested
- Postoperative transverse abdominal plain (TAP) blockade
- Keywords
- Postoperative pain, Transverse abdominal blockade, Efficacy, Safety, Urology
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative transverse abdominal plain (TAP) blockadeProcedure or surgery
Also called Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.)
Bupivacaine 0.25%. Maximum 150 mg. A maximum of 75 mg bupivacaine is administered in each side (posterior and subcostal TAP) in a single puncture.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard analgesic therapy: iv Metamizol 2 g q8h |
| TAP | Experimental | Transverse abdominal plain (TAP) blockade with local anesthetic: Bupivacaine chlorhydrate 0.25% adjusted by weight and type of surgery. Maximum dose: 150 mg of bupivacaine.
Two approaches are done: 1)Posterior TAP: the needle insertion point is cephalad to the iliac crest, behind the midaxillary line. The needle is inserted under ultrasound guidance in plane. Local anesthetics is deposited between the internal oblique and transversus abdominis muscles, 2)Subcostal TAP: the needle is inserted ultrasound guided perpendicularly to abdominal wall, directed parallel to the costal margin but oblique to the sagittal plane. Local anesthestic is deposited between transversus abdominis and the rectus abdominis muscles. Receives: Procedure: Postoperative transverse abdominal plain (TAP) blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Pain is assessed by numerical scale (0 to 10) where 0 is no pain and 10 is the most intense pain possible. Pain will be assessed at 4, 6 , 8, 12 and 24 hours.
Measured: Change in pain from admittance to 24 hours postoperatively
Secondary outcomes (5)
Analgesic consumption as a rescue therapy
Analgesic consumption: morphine in miligrams.
Measured: within 24 postoperative hours
Incidence of postoperative nausea and vomiting (PONV) related to therapy
Assessment of PONV incidence and antiemetic drugs consumption.
Measured: within 24 postoperative hours
Incidence of urethral/bladder spasm
Pain due to bladder catheter.
Measured: within 24 postoperative hours
Assessment of oral intake tolerance
Assessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours.
Measured: within 24 postoperative hours
Patient satisfaction
Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased
Measured: within 24 postoperative 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 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2012
- Study completionNov 2012
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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Puigvert
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Francisco Mayoral Farre, Fundacio Puigvert
- Investigators
- Juan Francisco Mayoral, MD, Principal investigator, Fundació Puigvert (IUNA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501565
- Sponsor's protocol ID
- FP2011/01
- Other IDs
- 2011-003219-53
- Status last verified
- Nov 2012
- First submitted
- 22 Dec 2011
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.
- ClinicalTrials.gov ID
- NCT01501565
- Acronym / sponsor ID
- FP2011/01
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Transverse abdominal blockade, Efficacy, Safety, Urology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Fundacio PuigvertUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Dec 2011 (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 purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12 and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP) and patients under conventional analgesia. Also the opioid consumption is assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard analgesic therapy: iv Metamizol 2 g q8h |
| TAP | Experimental | Procedure: Postoperative transverse abdominal plain (TAP) blockadeTransverse abdominal plain (TAP) blockade with local anesthetic: Bupivacaine chlorhydrate 0.25% adjusted by weight and type of surgery. Maximum dose: 150 mg of bupivacaine. Two approaches are done: 1)Posterior TAP: the needle insertion point is cephalad to the iliac crest, behind the midaxillary line. The needle is inserted under ultrasound guidance in plane. Local anesthetics is deposited between the internal oblique and transversus abdominis muscles, 2)Subcostal TAP: the needle is inserted ultrasound guided perpendicularly to abdominal wall, directed parallel to the costal margin but oblique to the sagittal plane. Local anesthestic is deposited between transversus abdominis and the rectus abdominis muscles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 18 yrs.
- Patients undergo laparoscopic urologic surgery
- Physical status ASA < 3
- Surgical procedure without complications
- Signed informed consent
Key exclusion criteria (7 listed)
- Allergy to bupivacaine chlorhydrate
- Patients with chronic pain treatment
- Alcoholism
- Decompensated hepatic disease
- Coagulation disorders
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 |
|---|---|---|
| Postoperative transverse abdominal plain (TAP) blockadeAlso: Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.)Bupivacaine 0.25%. Maximum 150 mg. A maximum of 75 mg bupivacaine is administered in each side (posterior and subcostal TAP) in a single puncture. | Procedure or surgery | TAP |
Primary outcome
Pain level
Time frame: Change in pain from admittance to 24 hours postoperatively
Pain is assessed by numerical scale (0 to 10) where 0 is no pain and 10 is the most intense pain possible. Pain will be assessed at 4, 6 , 8, 12 and 24 hours.
5 secondary outcomes
Analgesic consumption as a rescue therapy
Time frame: within 24 postoperative hours
Incidence of postoperative nausea and vomiting (PONV) related to therapy
Time frame: within 24 postoperative hours
Incidence of urethral/bladder spasm
Time frame: within 24 postoperative hours
Assessment of oral intake tolerance
Time frame: within 24 postoperative hours
Patient satisfaction
Time frame: within 24 postoperative 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 16 Nov 2012.
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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.
Juan Francisco Mayoral, MD principal investigator
Fundació Puigvert (IUNA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Postoperative transverse abdominal plain (TAP) blockade in people with Postoperative Pain, run by Fundacio Puigvert at 1 site in Spain.
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 5 inclusion and 7 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 16 Nov 2012. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain level (time frame: Change in pain from admittance to 24 hours postoperatively). 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 16 Nov 2012; AzTrials last refreshed its copy on 8 Nov 2026.