PainPhase 1/2NCT01866917

Study of TAP and Laparoscopic and Robotic Gynecologic Procedures and Obese Women

A Phase 1/2 study testing Ropivacaine 0.5% 20cc injectate bilaterally in people with Pain, run by Montefiore Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: Ropivacaine 0.5% 20cc injectate bilaterally
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Apr 2013to Apr 2016
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

BMI greater than or equal to 30, women undergoing laparoscopic or robotic in-patient procedures

Who cannot join

Conversions, non-obese women

Trial locations and contacts

1 site in 1 country.

United States1 site

Moses Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Effectiveness of Transversus Abdominis Plane Block in Reducing Immediate Postoperative Pain in Obese Women After Laparoscopic or Robotic Gynecologic Procedures

Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.

Conditions: Pain
Being tested: Ropivacaine 0.5% 20cc injectate bilaterally, Placebo
Keywords: Transversis Abdominis Plane Block, obese, robotic surgery, laparoscopic surgery
Medical subject headings: Pain, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ropivacaine 0.5% 20cc injectate bilaterallyDrug
PlaceboDrug
Also called Saline

Study groups in NCT01866917
Study group	Role	What they receive
TAP	Experimental	Patients will receive Ropivicaine 0.5% 20cc injectate from a study labeled syringe Receives: Drug: Ropivacaine 0.5% 20cc injectate bilaterally
Saline	Placebo comparator	Patients will receive Normal saline 20cc injectate from a study labeled syringe Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)
Pain assessments by verbal numerical pain score (NPS) at 0, 1 and 2 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable
Measured: 0, 1, and 2 hours
Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)
Pain assessments by verbal numerical pain score (NPS) at 4, 8, 12 and 24 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable
Measured: 4hrs, 8hrs, 12hrs, and 24hrs.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Apr 2016

First posted3 Jun 2013 (estimated)
Study startApr 2013
Primary completionApr 2016
Study completionApr 2016

Why it stopped: Pharmacy stopped dispensing study medication

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01866917
Sponsor's protocol ID: 12-11-397
Status last verified: Aug 2020
First submitted: 29 May 2013
Last updated: 20 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Transversus Abdominis Plane Block in Reducing Immediate Postoperative Pain in Obese Women After Laparoscopic or Robotic Gynecologic Procedures
ClinicalTrials.gov ID: NCT01866917
Acronym / sponsor ID: 12-11-397
Conditions: Pain
Keywords: Transversis Abdominis Plane Block, obese, robotic surgery, laparoscopic surgery
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Pharmacy stopped dispensing study medication
Enrolment: 35 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: Apr 2013 (actual)
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 3 Jun 2013 (estimated)
Results: Posted 20 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TAP	Experimental	Drug: Ropivacaine 0.5% 20cc injectate bilaterallyPatients will receive Ropivicaine 0.5% 20cc injectate from a study labeled syringe
Saline	Placebo comparator	Drug: PlaceboPatients will receive Normal saline 20cc injectate from a study labeled syringe

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

BMI greater than or equal to 30, women undergoing laparoscopic or robotic in-patient procedures

Key exclusion criteria (1 listed)

Conversions, non-obese women

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
Ropivacaine 0.5% 20cc injectate bilaterally	Drug	TAP
PlaceboAlso: Saline	Drug	Saline

Primary outcome

Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)
Time frame: 0, 1, and 2 hours
Pain assessments by verbal numerical pain score (NPS) at 0, 1 and 2 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable
Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)
Time frame: 4hrs, 8hrs, 12hrs, and 24hrs.
Pain assessments by verbal numerical pain score (NPS) at 4, 8, 12 and 24 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable

Results and safety

Results posted to the registry on 20 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transversus Abdominal Plane	17	13
Saline	18	12

Primary outcome: Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)

Time frame: 0, 1, and 2 hours. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Transversus Abdominis Plane (TAP) Group B n = 13	Saline Group A n = 12
0 hour	0 (0 to 8)	5.5 (0 to 9)
1 hour	3 (0 to 8)	3.5 (0 to 5)
2 hours	3 (0 to 6)	4.5 (0 to 5)

Transversus Abdominis Plane (TAP) Group B vs Saline Group A: p = .574, Chi-squared

Population analysed: There were 13 participants receiving the Transversus Abdominis Plane TAP (Group B) and 12 participants receiving the placebo Saline (Group A).

Primary outcome: Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)

Time frame: 4hrs, 8hrs, 12hrs, and 24hrs.. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Transversus Abdominis Plane (TAP) Group B n = 13	Saline Group A n = 12
4 hours	0 (0 to 7)	5.5 (0 to 6)
8 hours	1 (0 to 5)	2 (0 to 6)
12 hours	2 (0 to 6)	3 (0 to 5)
24 hours	3 (0 to 6)	1.5 (0 to 7)

Transversus Abdominis Plane (TAP) Group B vs Saline Group A: Interquartile range (IQR): 3, p = .825, Chi-squared

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group B (TAP Block)	0 of 0	0 of 0	0
Group A (Saline)	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Limitations of this study include interim analysis with limited sample size, thus it may result in inadequate power. Early termination due to pharmacist refusal to dispense the experimental Rx (no AEs/SAEs recorded). Only an abstract was written.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pain

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

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.

Ja Hyun Shin principal investigator

Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ropivacaine 0.5% 20cc injectate bilaterally in people with Pain, run by Montefiore Medical Center 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 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: stopped early, as of the sponsor's last update on 20 Aug 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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?

Yes. Results are posted in the registry (first posted 20 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) (time frame: 0, 1, and 2 hours). 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?

On the ClinicalTrials.gov record for NCT01866917.

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 20 Aug 2020.