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

NCT00508976 | Completed Phase 2 DMC

• 1 other identifier: PHH#07-005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Morbid Obesity

Keywords

bupivacaine; marcaine; lidocaine; normal saline; narcotics; analog pain scale; postoperative pain; preemptive; aerosolization; streamed

Outcome Measures

Primary Outcomes (1)

• Measure of reduction in post-operative pain and narcotics usage.

  First 3 days post-operatively.

Study Arms (4)

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

Interventions

Injected bupivacaine post-operatively DRUG

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.

Also known as: bupivacaine

1

Streamed bupivacaine versus streamed normal saline DRUG

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.

Also known as: bupivacaine, marcaine, normal saline

3

Aerosolized bupivacaine versus aerosolized saline DRUG

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.

Also known as: bupivacaine, marcaine, normal saline, aerosolized

4

Injected lidocaine pre-incision vs saline pre-incision DRUG

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.

Also known as: lidocaine, normal saline, pre-emptive

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pinnacle Health System: lead

Study Sites (1)

Pinnacle Health; Community General Osteopathic Hospital

Harrisburg, Pennsylvania, 17109, United States

Location

Related Publications (19)

• 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.

  PMID: 10475311 BACKGROUND

• 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.

  PMID: 17180268 BACKGROUND

• 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.

  PMID: 16703434 BACKGROUND

• 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.

  PMID: 16036193 BACKGROUND

• 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.

  PMID: 15572499 BACKGROUND

• 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.

  PMID: 8624007 BACKGROUND

• 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.

  PMID: 9293650 BACKGROUND

• 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.

  PMID: 9840560 BACKGROUND

• Kundu S, Achar S. Principles of office anesthesia: part II. Topical anesthesia. Am Fam Physician. 2002 Jul 1;66(1):99-102.

  PMID: 12126037 BACKGROUND

• 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.

  PMID: 15008770 BACKGROUND

• 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.

  PMID: 15573244 BACKGROUND

• 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.

  PMID: 12452227 BACKGROUND

• 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.

  PMID: 11988800 BACKGROUND

• Mixter CG 3rd, Hackett TR. Preemptive analgesia in the laparoscopic patient. Surg Endosc. 1997 Apr;11(4):351-3. doi: 10.1007/s004649900361.

  PMID: 9094275 BACKGROUND

• 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.

  PMID: 11873051 BACKGROUND

• Mouton WG, Bessell JR, Otten KT, Maddern GJ. Pain after laparoscopy. Surg Endosc. 1999 May;13(5):445-8. doi: 10.1007/s004649901011.

  PMID: 10227938 BACKGROUND

• Mouton WG, Bessell JR, Pfitzner J, Dymock RB, Brealey J, Maddern GJ. A randomized controlled trial to determine the effects of humidified carbon dioxide insufflation during thoracoscopy. Surg Endosc. 1999 Apr;13(4):382-5. doi: 10.1007/s004649900994.

  PMID: 10094752 BACKGROUND

• Mouton WG, Bessell JR, Millard SH, Baxter PS, Maddern GJ. A randomized controlled trial assessing the benefit of humidified insufflation gas during laparoscopic surgery. Surg Endosc. 1999 Feb;13(2):106-8. doi: 10.1007/s004649900915.

  PMID: 9918607 BACKGROUND

• Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute postoperative pain management: a meta-analysis. Anesth Analg. 2005 Mar;100(3):757-773. doi: 10.1213/01.ANE.0000144428.98767.0E.

  PMID: 15728066 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Obesity, Morbid

Interventions

Bupivacaine; Saline Solution; Aerosolized Particles and Droplets; Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Complex Mixtures; Acetanilides

Study Officials

• Troy A Moritz, DO

  Pinnacle Health; Community General Osteopathic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Troy Moritz DO

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: June 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

US (1)