Postoperative PainNCT01204892
Pain After Laparoscopic Cholecystectomy With Bilateral Tranversus Abdominis Plane (TAP) Block Versus Local Anesthetic Infiltration
A study testing TAP Block and Local infiltration in people with Postoperative Pain, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- TAP Block and Local infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to May 2011
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient ages 18-64
- American Society of Anesthesiology Physical Status I, II or III
- Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital
Who cannot join
- Open cholecystectomy - excluded due to increased levels of pain in open procedures
- Scheduled for ambulatory surgery
- Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
- Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
- Allergy or contraindication to any of the study medications or anesthetic agents
- Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
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- Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
- Pregnancy
- Prisoners
- Patient or surgeon refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain After Laparoscopic Cholecystectomy in Patients Receiving Bilateral Ultrasound-guided Transverse Abdominis Plane Block Compared With Local Anesthetic Infiltration of Trochar Insertion Sites With Ropivacaine 0.5%
The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.
Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.
Read the detailed description
The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.
Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.
- Conditions
- Postoperative Pain
- Being tested
- TAP Block, Local infiltration
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP BlockProcedure or surgery
Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia
Local infiltrationProcedure or surgery
20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports
| Study group | Role | What they receive |
|---|---|---|
| TAP Block | Active comparator | Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia Receives: Procedure: TAP Block |
| Local infiltration | Active comparator | 20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports Receives: Procedure: Local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain scores on NAS scale (0-10) at the following times:
Preop, Time 0, Time 1, Time 2, Time 4, Time 8, Time 12, Time 24
Measured: 24 hours
Secondary outcomes (2)
PONV (Postoperative nausea and vomiting)
PONV events in first 24 hours
Measured: 24 hours
Narcotics use
Fentanyl, morphine, and hydrocodone/apap total for 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
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.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ortiz, Baylor College of Medicine
- Investigators
- Jaime Ortiz, MD, Principal investigator, Batylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204892
- Sponsor's protocol ID
- H-27128
- Status last verified
- Jul 2012
- First submitted
- 16 Sep 2010
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Laparoscopic Cholecystectomy in Patients Receiving Bilateral Ultrasound-guided Transverse Abdominis Plane Block Compared With Local Anesthetic Infiltration of Trochar Insertion Sites With Ropivacaine 0.5%
- ClinicalTrials.gov ID
- NCT01204892
- Acronym / sponsor ID
- H-27128
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Sep 2010 (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 if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.
Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.
Detailed description
The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.
Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block | Active comparator | Procedure: TAP BlockPatient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia |
| Local infiltration | Active comparator | Procedure: Local infiltration20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient ages 18-64
- American Society of Anesthesiology Physical Status I, II or III
- Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital
Key exclusion criteria (10 listed)
- Open cholecystectomy - excluded due to increased levels of pain in open procedures
- Scheduled for ambulatory surgery
- Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
- Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
- Allergy or contraindication to any of the study medications or anesthetic agents
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 BlockPatient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia | Procedure or surgery | TAP Block |
| Local infiltration20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports | Procedure or surgery | Local infiltration |
Primary outcome
Pain
Time frame: 24 hours
Pain scores on NAS scale (0-10) at the following times: Preop, Time 0, Time 1, Time 2, Time 4, Time 8, Time 12, Time 24
2 secondary outcomes
PONV (Postoperative nausea and vomiting)
Time frame: 24 hours
Narcotics use
Time frame: 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 12 Jul 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.
Jaime Ortiz, MD principal investigator
Batylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP Block and Local infiltration in people with Postoperative Pain, run by Baylor College of Medicine at 1 site in United States.
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 3 inclusion and 10 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 12 Jul 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 United States. 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 (time frame: 24 hours). 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 12 Jul 2012.