PainNCT01075087

The Effect of Pre-Operative Transversus Abdominis Plane (TAP) Block in the Post Operative Opioid Consumption in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study

A study testing (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. in people with Pain and Obesity, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The use of preoperative TAP block in laparoscopic bariatric surgery can improve the postoperative pain and quality of recovery in patients undergoing these procedures. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pain, Obesity, Surgery
What is being tested?: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: 1 siteUnited States
Study dates: Mar 2010to Aug 2012
Phase: Interventional
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: 18-65 years
BMI >35 Kg/m2
Surgery: laparoscopic gastric bypass surgery
ASA status: I, II and III
Fluent in English

Who cannot join

History of allergy to local anesthetics
Chronic opioid use
Pregnant patients
Patients who remained intubated after surgery
Drop-out criteria:
Patient or surgeon request Complications related to the procedure or conversion to open route Patient requiring mechanical ventilation after surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern Memorial Hospital
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: TAP) Block in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study

The use of preoperative TAP block in laparoscopic bariatric surgery can improve the postoperative pain and quality of recovery in patients undergoing these procedures.

Conditions: Pain, Obesity, Surgery
Being tested: Placebo, (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
Keywords: TAP Block, Pain, Obesity, Surgery, Laparoscopic Banding
Medical subject headings: Pain, Obesity

What participants receive

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

PlaceboDrug
Bilateral TAP block using sterile normal saline.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.Drug
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

Study groups in NCT01075087
Study group	Role	What they receive
Placebo	Placebo comparator	(control group) will receive sterile normal saline in the block Receives: Drug: Placebo
Active comparator	Active comparator	(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. Receives: Drug: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

What is being measured

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

Quality of Recovery 40 Score
Quality of Recovery 40 Score at 24 hours postoperative.
Measured: 24 hours post operatively

Secondary outcomes (1)

24 Hour Total Opioid Consumption.
24 Hour total opioid consumption translated into IV morphine equivalents.
Measured: 24 hours

Timeline

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

Mar 2010Aug 2012

First posted24 Feb 2010 (estimated)
Study startMar 2010
Primary completionJul 2012
Study completionAug 2012

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.
Publications (11)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01075087
Sponsor's protocol ID: STU00023482
Status last verified: May 2014
First submitted: 23 Feb 2010
Last updated: 26 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mun EC, Blackburn GL, Matthews JB. Current status of medical and surgical therapy for obesity. Gastroenterology. 2001 Feb;120(3):669-81. doi: 10.1053/gast.2001.22430.
PubMed 11179243
Peiser J, Lavie P, Ovnat A, Charuzi I. Sleep apnea syndrome in the morbidly obese as an indication for weight reduction surgery. Ann Surg. 1984 Jan;199(1):112-5. doi: 10.1097/00000658-198401000-00020.
PubMed 6691724
Kyzer S, Charuzi I. Obstructive sleep apnea in the obese. World J Surg. 1998 Sep;22(9):998-1001. doi: 10.1007/s002689900506.
PubMed 9717428
Rosenberg-Adamsen S, Kehlet H, Dodds C, Rosenberg J. Postoperative sleep disturbances: mechanisms and clinical implications. Br J Anaesth. 1996 Apr;76(4):552-9. doi: 10.1093/bja/76.4.552. No abstract available.
PubMed 8652329
Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82.
PubMed 3354874
Dhonneur G, Combes X, Leroux B, Duvaldestin P. Postoperative obstructive apnea. Anesth Analg. 1999 Sep;89(3):762-7. doi: 10.1097/00000539-199909000-00045.
PubMed 10475322
Chung F, Crago RR. Sleep apnoea syndrome and anaesthesia. Can Anaesth Soc J. 1982 Sep;29(5):439-45. doi: 10.1007/BF03009406.
PubMed 6751498
Passannante AN, Tielborg M. Anesthetic management of patients with obesity with and without sleep apnea. Clin Chest Med. 2009 Sep;30(3):569-79, x. doi: 10.1016/j.ccm.2009.05.009.
PubMed 19700053
Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.
PubMed 10718794
Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.
PubMed 10910857
Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. doi: 10.1046/j.1365-2044.2001.02215.x.
PubMed 11703235

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?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TAP) Block in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study
ClinicalTrials.gov ID: NCT01075087
Acronym / sponsor ID: STU00023482
Conditions: Pain, Obesity, Surgery
Keywords: TAP Block, Pain, Obesity, Surgery, Laparoscopic Banding
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: Mar 2010
Primary completion: Jul 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 24 Feb 2010 (estimated)
Results: Posted 26 Jun 2014

Clinical summary

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

The use of preoperative TAP block in laparoscopic bariatric surgery can improve the postoperative pain and quality of recovery in patients undergoing these procedures.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo(control group) will receive sterile normal saline in the block
Active comparator	Active comparator	Drug: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age: 18-65 years
BMI >35 Kg/m2
Surgery: laparoscopic gastric bypass surgery
ASA status: I, II and III
Fluent in English

Key exclusion criteria (6 listed)

History of allergy to local anesthetics
Chronic opioid use
Pregnant patients
Patients who remained intubated after surgery
Patient or surgeon request Complications related to the procedure or conversion to open route Patient requiring mechanical ventilation after surgery

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
PlaceboBilateral TAP block using sterile normal saline.	Drug	Placebo
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.	Drug	Active comparator

Primary outcome

Quality of Recovery 40 Score
Time frame: 24 hours post operatively
Quality of Recovery 40 Score at 24 hours postoperative.

1 secondary outcome

24 Hour Total Opioid Consumption.
Time frame: 24 hours

Results and safety

Results posted to the registry on 26 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	9	9
Active Comparator	10	10

Primary outcome: Quality of Recovery 40 Score

Time frame: 24 hours post operatively. Median (Inter-Quartile Range). Unit: units on scale 40 (low) - 200 (high)

Measure	Placebo n = 9	Active Comparator n = 10
Value	170 (160 to 175)	175.5 (170 to 189)

Placebo vs Active Comparator: Median Difference (Net): -5.5 (90% CI -26 to 3), p = .05, Wilcoxon (Mann-Whitney)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 9 (0%)	3 of 9 (33.3%)	Not reported
Active Comparator	0 of 10 (0%)	1 of 10 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11179243Mun EC, Blackburn GL, Matthews JB. Current status of medical and surgical therapy for obesity. Gastroenterology. 2001 Feb;120(3):669-81. doi: 10.1053/gast.2001.22430.
Background: PubMed 6691724Peiser J, Lavie P, Ovnat A, Charuzi I. Sleep apnea syndrome in the morbidly obese as an indication for weight reduction surgery. Ann Surg. 1984 Jan;199(1):112-5. doi: 10.1097/00000658-198401000-00020.
Background: PubMed 9717428Kyzer S, Charuzi I. Obstructive sleep apnea in the obese. World J Surg. 1998 Sep;22(9):998-1001. doi: 10.1007/s002689900506.
Background: PubMed 8652329Rosenberg-Adamsen S, Kehlet H, Dodds C, Rosenberg J. Postoperative sleep disturbances: mechanisms and clinical implications. Br J Anaesth. 1996 Apr;76(4):552-9. doi: 10.1093/bja/76.4.552. No abstract available.
Background: PubMed 3354874Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82.
Background: PubMed 10475322Dhonneur G, Combes X, Leroux B, Duvaldestin P. Postoperative obstructive apnea. Anesth Analg. 1999 Sep;89(3):762-7. doi: 10.1097/00000539-199909000-00045.
Background: PubMed 6751498Chung F, Crago RR. Sleep apnoea syndrome and anaesthesia. Can Anaesth Soc J. 1982 Sep;29(5):439-45. doi: 10.1007/BF03009406.
Background: PubMed 19700053Passannante AN, Tielborg M. Anesthetic management of patients with obesity with and without sleep apnea. Clin Chest Med. 2009 Sep;30(3):569-79, x. doi: 10.1016/j.ccm.2009.05.009.
Background: PubMed 10718794Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.
Background: PubMed 10910857Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.
Background: PubMed 11703235Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. doi: 10.1046/j.1365-2044.2001.02215.x.

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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.

Gildasio DeOliveira, MD principal investigator

Northwestern University

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

Questions about this trial

What is this clinical trial studying?

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 6 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 26 Jun 2014. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2014). 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?

Quality of Recovery 40 Score (time frame: 24 hours post operatively). 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 NCT01075087, which also lists 11 linked publications.

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 26 Jun 2014.