PainNCT01180660

IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery

A study testing Lidocaine Infusion and Normal Saline 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

Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Pain, Obesity
What is being tested?: Lidocaine Infusion and Normal Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Nov 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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ASA I, II,III;
BMI > 35 kg/m2,
Age between 18-70,
Fluent in English,
Patients undergoing laparoscopic gastric bypass,
EKG within 3 months.

Who cannot join

History of allergy to local anesthetics,
History of chronic opioid use,
Pregnant patients,
History of EKG abnormalities.
Dropout: Conversion to open, patient or surgeon request.

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: The Effect of Systemic Intraoperative Lidocaine on Postoperative Pain and Quality of Recovery on Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery

This study has the potential to confirm an opioid sparing strategy for morbid obese patients undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea and the increased risk of postoperative hypoxemia make the development of opioid sparing techniques in this patient population warranted.

Conditions: Pain, Obesity
Being tested: Lidocaine Infusion, Normal Saline
Keywords: Gastric Surgery, Pain, Recovery, 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.

Lidocaine InfusionDrug
1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period
Normal SalineDrug
Also called Placebo infusion
Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period

Study groups in NCT01180660
Study group	Role	What they receive
Lidocaine	Active comparator	Lidocaine infusion Receives: Drug: Lidocaine Infusion
Placebo	Placebo comparator	Placebo Normal Saline Infusion Receives: Drug: Normal Saline

What is being measured

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

Quality of Recovery 40 on the Day After Surgery
Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high.
The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery.
Measured: 24 hours

Secondary outcomes (1)

24 Hour Total Opioid Consumption
24 hour total opioid consumption using IV morphine equivalents
Measured: 24 hours post surgery

Timeline

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

Jun 2010Nov 2012

First posted12 Aug 2010 (estimated)
Study startJun 2010
Primary completionOct 2012
Study completionNov 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 (9)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: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01180660
Sponsor's protocol ID: STU00032300
Status last verified: Jul 2014
First submitted: 19 Jul 2010
Last updated: 7 Aug 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
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
Moiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth. 1998 Sep;81(3):377-83. doi: 10.1093/bja/81.3.377.
PubMed 9861124

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 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Systemic Intraoperative Lidocaine on Postoperative Pain and Quality of Recovery on Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery
ClinicalTrials.gov ID: NCT01180660
Acronym / sponsor ID: STU00032300
Conditions: Pain, Obesity
Keywords: Gastric Surgery, Pain, Recovery, Laparoscopic Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: Jun 2010
Primary completion: Oct 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 12 Aug 2010 (estimated)
Results: Posted 7 Aug 2014

Clinical summary

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

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
Lidocaine	Active comparator	Drug: Lidocaine InfusionLidocaine infusion
Placebo	Placebo comparator	Drug: Normal SalinePlacebo Normal Saline Infusion

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

ASA I, II,III;
BMI > 35 kg/m2,
Age between 18-70,
Fluent in English,
Patients undergoing laparoscopic gastric bypass,

Key exclusion criteria (5 listed)

History of allergy to local anesthetics,
History of chronic opioid use,
Pregnant patients,
History of EKG abnormalities.
Dropout: Conversion to open, patient or surgeon request.

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
Lidocaine Infusion1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period	Drug	Lidocaine
Normal SalineAlso: Placebo infusionSaline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period	Drug	Placebo

Primary outcome

Quality of Recovery 40 on the Day After Surgery
Time frame: 24 hours
Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high. The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery.

1 secondary outcome

24 Hour Total Opioid Consumption
Time frame: 24 hours post surgery

Results and safety

Results posted to the registry on 7 Aug 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
Lidocaine	25	24
Placebo	26	26

Primary outcome: Quality of Recovery 40 on the Day After Surgery

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

Measure	Lidocaine n = 24	Placebo n = 26
Value	165 (151 to 170)	146 (130 to 169)

Lidocaine vs Placebo: Median Difference (Net): 19 (95% CI 3 to 27), p = .01, Regression, Linear

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 hours after surgery. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lidocaine	0 of 24 (0%)	5 of 24 (20.8%)	Not reported
Placebo	0 of 26 (0%)	14 of 26 (53.8%)	Not reported

Limitations and caveats (from the sponsor): We did not evaluate if the opioid sparing properties of systemic lidocaine resulted in a lower incidence of adverse respiratory events (hypoxemia/hypoventilation). We were underpowered to detect significant differences in certain parts of the qor-40.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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 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.
Background: PubMed 9861124Moiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth. 1998 Sep;81(3):377-83. doi: 10.1093/bja/81.3.377.

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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 De Oliveira, M.D 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?

A study testing Lidocaine Infusion and Normal Saline in people with Pain and Obesity, run by Northwestern University 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 6 inclusion and 5 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 7 Aug 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 7 Aug 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 on the Day After Surgery (time frame: 24 hours). 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 NCT01180660, which also lists 9 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 7 Aug 2014.