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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508976
• Other study ID #: PHH#07-005
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2007
• Last updated: May 9, 2012
• Start date: June 2007
• Est. completion date: April 2008

Study information

• Verified date: May 2012
• Source: Pinnacle Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male and female patients between 18 and 65 years of age.

2. Patients undergoing elective bariatric surgery.

Exclusion Criteria:

1. Patients allergic to bupivacaine or any other local anesthetics (amides & esters).

2. Patients who have used opiates or opiods within 15 days prior to surgery.

3. Patients converted to open gastric bypass.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Pain, Postoperative

Intervention

Drug:
• Injected bupivacaine post-operatively
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 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 saline
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-incision
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.

Locations

Country	Name	City	State
United States	Pinnacle Health; Community General Osteopathic Hospital	Harrisburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pinnacle Health System

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Epub 2006 Dec 16. — View Citation

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. Epub 2006 May 13. — View Citation

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. — View Citation

Einarsson JI, Sun J, Orav J, Young AE. Local analgesia in laparoscopy: a randomized trial. Obstet Gynecol. 2004 Dec;104(6):1335-9. — View Citation

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. — View Citation

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. Erratum in: Acta Anaesthesiol Sin 1997 Sep;35(3):191. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Epub 2004 Sep 29. — View Citation

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. Epub 2002 May 7. — View Citation

Mixter CG 3rd, Hackett TR. Preemptive analgesia in the laparoscopic patient. Surg Endosc. 1997 Apr;11(4):351-3. — View Citation

Møiniche 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. Review. — View Citation

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. — View Citation

Mouton WG, Bessell JR, Otten KT, Maddern GJ. Pain after laparoscopy. Surg Endosc. 1999 May;13(5):445-8. Review. — View Citation

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. — View Citation

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):757-73, table of contents. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of reduction in post-operative pain and narcotics usage.		First 3 days post-operatively.	No