Pain, PostoperativePhase 2NCT00508976

Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic

A Phase 2 study testing Injected bupivacaine post-operatively, Streamed bupivacaine versus streamed normal saline and Aerosolized bupivacaine versus aerosolized saline in people with Pain, Postoperative and Morbid Obesity, run by Pinnacle Health System 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 purpose of this study is to determine if pre-incisional lidocaine injection, instilled liquid bupivacaine, intra-abdominal aerosolized bupivacaine, or post-operative bupivacaine injection is superior in post-operative pain control in laparoscopic bariatric surgical patients. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Pain, Postoperative, Morbid Obesity
What is being tested?: Injected bupivacaine post-operatively, Streamed bupivacaine versus streamed normal saline and Aerosolized bupivacaine versus aerosolized saline
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Apr 2008
Phase: Phase 2
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female patients between 18 and 65 years of age.
Patients undergoing elective bariatric surgery.

Who cannot join

Patients allergic to bupivacaine or any other local anesthetics (amides \& esters).
Patients who have used opiates or opiods within 15 days prior to surgery.
Patients converted to open gastric bypass.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pinnacle Health; Community General Osteopathic Hospital
Harrisburg, Pennsylvania, 17109

Other trials in United States

About this study

Official title: Evaluation of Aerosolized Bupivacaine Versus Pre-incision Lidocaine Versus Instilled Liquid Bupivacaine Versus Post-operative Bupivacaine Injection for Optimization of Post-operative Pain Control in Laparoscopic Bariatric Surgical Patients

Read the detailed description

The research objective is to compare our standard post-operative port site injection of 0.5% bupivacaine against pre-incisional port site injection of 1% lidocaine against the instillation of streamed bupivacaine 0.5% against the instillation of aerosolized 0.5% bupivacaine as it relates to post-operative analgesia usage and pain scale scores. The null hypothesis will be that there is no difference between the four arms of the study in regards to pain score and analgesia usage.

Conditions: Pain, Postoperative, Morbid Obesity
Being tested: Injected bupivacaine post-operatively, Streamed bupivacaine versus streamed normal saline, Aerosolized bupivacaine versus aerosolized saline, Injected lidocaine pre-incision vs saline pre-incision
Keywords: bupivacaine, marcaine, lidocaine, normal saline, narcotics, analog pain scale, postoperative pain, preemptive, aerosolization, streamed
Medical subject headings: Pain, Postoperative, Obesity, Morbid

What participants receive

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

Injected bupivacaine post-operativelyDrug
Also called bupivacaine
Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation, and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
Streamed bupivacaine versus streamed normal salineDrug
Also called bupivacaine, marcaine, normal saline
Patients will receive 30ml of 0.9% normal saline divided equally and injected prior to port site incisions, then 10ml of 0.5% bupivacaine streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
Aerosolized bupivacaine versus aerosolized salineDrug
Also called bupivacaine, marcaine, normal saline, aerosolized
Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.5% bupivacaine aerosolized into coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.
Injected lidocaine pre-incision vs saline pre-incisionDrug
Also called lidocaine, normal saline, pre-emptive
Patients will receive 30ml of 1% lidocaine divided equally and injected prior to port site incisions, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.

Study groups in NCT00508976
Study group	Role	What they receive
3	Experimental	Not described Receives: Drug: Streamed bupivacaine versus streamed normal saline
2	Experimental	Not described Receives: Drug: Injected lidocaine pre-incision vs saline pre-incision
4	Experimental	Not described Receives: Drug: Aerosolized bupivacaine versus aerosolized saline
1	Active comparator	Not described Receives: Drug: Injected bupivacaine post-operatively

What is being measured

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

Measure of reduction in post-operative pain and narcotics usage.
Measured: First 3 days post-operatively.

Timeline

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

Jun 2007Apr 2008

First posted30 Jul 2007 (estimated)
Study startJun 2007
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00508976
Sponsor's protocol ID: PHH#07-005
Status last verified: May 2012
First submitted: 26 Jul 2007
Last updated: 10 May 2012
Results posted: No
Data monitoring committee: Yes

Publications

Aida S, Baba H, Yamakura T, Taga K, Fukuda S, Shimoji K. The effectiveness of preemptive analgesia varies according to the type of surgery: a randomized, double-blind study. Anesth Analg. 1999 Sep;89(3):711-6. doi: 10.1097/00000539-199909000-00034.
PubMed 10475311
Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.
PubMed 17180268
Barczynski M, Konturek A, Herman RM. Superiority of preemptive analgesia with intraperitoneal instillation of bupivacaine before rather than after the creation of pneumoperitoneum for laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. Surg Endosc. 2006 Jul;20(7):1088-93. doi: 10.1007/s00464-005-0458-1. Epub 2006 May 13.
PubMed 16703434
Chou YJ, Ou YC, Lan KC, Jawan B, Chang SY, Kung FT. Preemptive analgesia installation during gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):330-5. doi: 10.1016/j.jmig.2005.05.005.
PubMed 16036193
Einarsson JI, Sun J, Orav J, Young AE. Local analgesia in laparoscopy: a randomized trial. Obstet Gynecol. 2004 Dec;104(6):1335-9. doi: 10.1097/01.AOG.0000146283.90934.fd.
PubMed 15572499
Fletcher D, Kayser V, Guilbaud G. Influence of timing of administration on the analgesic effect of bupivacaine infiltration in carrageenin-injected rats. Anesthesiology. 1996 May;84(5):1129-37. doi: 10.1097/00000542-199605000-00015.
PubMed 8624007
Huang SJ, Wang JJ, Ho ST, Liu HS, Liaw WJ, Li MJ, Liu YH. The preemptive effect of pre-incisional bupivacaine infiltration on postoperative analgesia following lower abdominal surgery under epidural anesthesia. Acta Anaesthesiol Sin. 1997 Jun;35(2):97-102.
PubMed 9293650
Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5. doi: 10.1016/s0029-7844(98)00303-2.
PubMed 9840560
Kundu S, Achar S. Principles of office anesthesia: part II. Topical anesthesia. Am Fam Physician. 2002 Jul 1;66(1):99-102.
PubMed 12126037
Lam KW, Pun TC, Ng EH, Wong KS. Efficacy of preemptive analgesia for wound pain after laparoscopic operations in infertile women: a randomised, double-blind and placebo control study. BJOG. 2004 Apr;111(4):340-4. doi: 10.1111/j.1471-0528.2004.00083.x.
PubMed 15008770
Lohsiriwat V, Lert-akyamanee N, Rushatamukayanunt W. Efficacy of pre-incisional bupivacaine infiltration on postoperative pain relief after appendectomy: prospective double-blind randomized trial. World J Surg. 2004 Oct;28(10):947-50. doi: 10.1007/s00268-004-7471-8. Epub 2004 Sep 29.
PubMed 15573244
Jiranantarat V, Rushatamukayanunt W, Lert-akyamanee N, Sirijearanai R, Piromrat I, Suwannanonda P, Muangkasem J. Analgesic effect of intraperitoneal instillation of bupivacaine for postoperative laparoscopic cholecystectomy. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S897-903.
PubMed 12452227
Maestroni U, Sortini D, Devito C, Pour Morad Kohan Brunaldi F, Anania G, Pavanelli L, Pasqualucci A, Donini A. A new method of preemptive analgesia in laparoscopic cholecystectomy. Surg Endosc. 2002 Sep;16(9):1336-40. doi: 10.1007/s00464-001-9181-8. Epub 2002 May 7.
PubMed 11988800
Mixter CG 3rd, Hackett TR. Preemptive analgesia in the laparoscopic patient. Surg Endosc. 1997 Apr;11(4):351-3. doi: 10.1007/s004649900361.
PubMed 9094275
Moiniche S, Kehlet H, Dahl JB. A qualitative and quantitative systematic review of preemptive analgesia for postoperative pain relief: the role of timing of analgesia. Anesthesiology. 2002 Mar;96(3):725-41. doi: 10.1097/00000542-200203000-00032. No abstract available.
PubMed 11873051

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 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Aerosolized Bupivacaine Versus Pre-incision Lidocaine Versus Instilled Liquid Bupivacaine Versus Post-operative Bupivacaine Injection for Optimization of Post-operative Pain Control in Laparoscopic Bariatric Surgical Patients
ClinicalTrials.gov ID: NCT00508976
Acronym / sponsor ID: PHH#07-005
Conditions: Pain, Postoperative, Morbid Obesity
Keywords: bupivacaine, marcaine, lidocaine, normal saline, narcotics, analog pain scale, postoperative pain, preemptive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Pinnacle Health SystemUniversity, hospital or other
Study start: Jun 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 30 Jul 2007 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
3	Experimental	Drug: Streamed bupivacaine versus streamed normal saline
2	Experimental	Drug: Injected lidocaine pre-incision vs saline pre-incision
4	Experimental	Drug: Aerosolized bupivacaine versus aerosolized saline
1	Active comparator	Drug: Injected bupivacaine post-operatively

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male and female patients between 18 and 65 years of age.
Patients undergoing elective bariatric surgery.

Key exclusion criteria (3 listed)

Patients allergic to bupivacaine or any other local anesthetics (amides \& esters).
Patients who have used opiates or opiods within 15 days prior to surgery.
Patients converted to open gastric bypass.

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
Injected bupivacaine post-operativelyAlso: bupivacainePatients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation, and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.	Drug	1
Streamed bupivacaine versus streamed normal salineAlso: bupivacaine, marcaine, normal salinePatients will receive 30ml of 0.9% normal saline divided equally and injected prior to port site incisions, then 10ml of 0.5% bupivacaine streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.	Drug	3
Aerosolized bupivacaine versus aerosolized salineAlso: bupivacaine, marcaine, normal saline, aerosolizedPatients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.5% bupivacaine aerosolized into coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.	Drug	4
Injected lidocaine pre-incision vs saline pre-incisionAlso: lidocaine, normal saline, pre-emptivePatients will receive 30ml of 1% lidocaine divided equally and injected prior to port site incisions, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.	Drug	2

Primary outcome

Measure of reduction in post-operative pain and narcotics usage.
Time frame: First 3 days post-operatively.

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 10 May 2012.
Background: PubMed 10475311Aida S, Baba H, Yamakura T, Taga K, Fukuda S, Shimoji K. The effectiveness of preemptive analgesia varies according to the type of surgery: a randomized, double-blind study. Anesth Analg. 1999 Sep;89(3):711-6. doi: 10.1097/00000539-199909000-00034.
Background: PubMed 17180268Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.
Background: PubMed 16703434Barczynski M, Konturek A, Herman RM. Superiority of preemptive analgesia with intraperitoneal instillation of bupivacaine before rather than after the creation of pneumoperitoneum for laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. Surg Endosc. 2006 Jul;20(7):1088-93. doi: 10.1007/s00464-005-0458-1. Epub 2006 May 13.
Background: PubMed 16036193Chou YJ, Ou YC, Lan KC, Jawan B, Chang SY, Kung FT. Preemptive analgesia installation during gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):330-5. doi: 10.1016/j.jmig.2005.05.005.
Background: PubMed 15572499Einarsson JI, Sun J, Orav J, Young AE. Local analgesia in laparoscopy: a randomized trial. Obstet Gynecol. 2004 Dec;104(6):1335-9. doi: 10.1097/01.AOG.0000146283.90934.fd.
Background: PubMed 8624007Fletcher D, Kayser V, Guilbaud G. Influence of timing of administration on the analgesic effect of bupivacaine infiltration in carrageenin-injected rats. Anesthesiology. 1996 May;84(5):1129-37. doi: 10.1097/00000542-199605000-00015.
Background: PubMed 9293650Huang SJ, Wang JJ, Ho ST, Liu HS, Liaw WJ, Li MJ, Liu YH. The preemptive effect of pre-incisional bupivacaine infiltration on postoperative analgesia following lower abdominal surgery under epidural anesthesia. Acta Anaesthesiol Sin. 1997 Jun;35(2):97-102.
Background: PubMed 9840560Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5. doi: 10.1016/s0029-7844(98)00303-2.
Background: PubMed 12126037Kundu S, Achar S. Principles of office anesthesia: part II. Topical anesthesia. Am Fam Physician. 2002 Jul 1;66(1):99-102.
Background: PubMed 15008770Lam KW, Pun TC, Ng EH, Wong KS. Efficacy of preemptive analgesia for wound pain after laparoscopic operations in infertile women: a randomised, double-blind and placebo control study. BJOG. 2004 Apr;111(4):340-4. doi: 10.1111/j.1471-0528.2004.00083.x.
Background: PubMed 15573244Lohsiriwat V, Lert-akyamanee N, Rushatamukayanunt W. Efficacy of pre-incisional bupivacaine infiltration on postoperative pain relief after appendectomy: prospective double-blind randomized trial. World J Surg. 2004 Oct;28(10):947-50. doi: 10.1007/s00268-004-7471-8. Epub 2004 Sep 29.
Background: PubMed 12452227Jiranantarat V, Rushatamukayanunt W, Lert-akyamanee N, Sirijearanai R, Piromrat I, Suwannanonda P, Muangkasem J. Analgesic effect of intraperitoneal instillation of bupivacaine for postoperative laparoscopic cholecystectomy. J Med Assoc Thai. 2002 Sep;85 Suppl 3:S897-903.

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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.

Troy A Moritz, DO principal investigator

Pinnacle Health; Community General Osteopathic Hospital

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 2 inclusion and 3 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 10 May 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.

What does this phase mean?

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?

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?

Measure of reduction in post-operative pain and narcotics usage. (time frame: First 3 days 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 NCT00508976, which also lists 19 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 10 May 2012.