A double-blind, randomized, active-controlledstudy for post- hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation

American Surgeon

Volumn 78, Issue 5, 2012, Pages 574-581

  Haas, Eric ^a   Onel, Erol ^b   Miller, Howard ^c   Ragupathi, Madhu ^a   White, Paul F ^d  

^a LLP   (United States)

^b Pacira Pharmaceuticals Inc   (United States)

^c Woman's Hospital of Texas and Fannin Surgicare   (United States)

^d CEDARS SINAI MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADRENALIN; BUPIVACAINE; LIPOSOME;

ABDOMINAL DISTENSION; ADULT; ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CONSTIPATION; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG ERUPTION; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; FEMALE; FLATULENCE; HEMATOCHEZIA; HEMORRHOIDECTOMY; HUMAN; INTESTINAL DYSMOTILITY; LIPOSOMAL DELIVERY; MAJOR CLINICAL STUDY; MALE; NAUSEA; OUTCOME ASSESSMENT; PAIN ASSESSMENT; POSTOPERATIVE CARE; POSTOPERATIVE PAIN; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RECTUM HEMORRHAGE; RHINOPHARYNGITIS; SINGLE DRUG DOSE; SKIN IRRITATION; TREATMENT DURATION; URINARY TRACT INFECTION; VOMITING;

ANALGESIA; ANALGESICS; ANESTHETICS, LOCAL; BUPIVACAINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FOLLOW-UP STUDIES; HEMORRHOIDS; HUMANS; INJECTIONS; LIPOSOMES; PAIN MANAGEMENT; PAIN MEASUREMENT; PAIN, POSTOPERATIVE; RETROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 84862848946     PISSN: 00031348     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (24)

1. Hall MJ, DeFrances CJ,Williams SN, et al. National Hospital Discharge Survey: 2007 summary. Natl Health Stat Report 2010; 29:1-20, 24.
2. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report 2009;11:1-25.
3. Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol 2010;23:697-703.
4. Apfelbaum JL, Chen C,Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg 2003;97:534-40. (Pubitemid 36899761)
5. White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs 2008;9:76-82.
6. Hetzer FH, Demartines N, Handschin AE, Clavien PA. Stapled vs excision hemorrhoidectomy: long-term results of a prospective randomized trial. Arch Surg 2002;137:337-40. (Pubitemid 34207997)
7. Jirasiritham S, Tantivitayatan K, Jirasiritham S. Perianal blockage with 0.5% bupivacaine for postoperative pain relief in hemorrhoidectomy. J Med Assoc Thai 2004;87:660-4. (Pubitemid 39163105)
8. Chester JF, Stanford BJ, Gazet JC. Analgesic benefit of locally injected bupivacaine after hemorrhoidectomy. Dis Colon Rectum 1990;33:487-9. (Pubitemid 20187508)
9. Vinson-Bonnet B, Coltat JC, Fingerhut A, Bonnet F. Local infiltration with ropivacaine improves immediate postoperative pain control after hemorrhoidal surgery. Dis Colon Rectum 2002;45:104-8. (Pubitemid 34072759)
10. Lohsiriwat D, Lohsiriwat V. Outpatient hemorrhoidectomy under perianal anesthetics infiltration. JMed Assoc Thai 2005;88:1821-4. (Pubitemid 43275716)
11. Brunat G, Pouzeratte Y, Mann C, et al. Posterior perineal block with ropivacaine 0.75% for pain control during and after hemorrhoidectomy. Reg Anesth Pain Med 2003;28:228-32. (Pubitemid 36618317)
12. Forastiere E, Sofra M, Giannarelli D, et al. Effectiveness of continuous wound infusion of 0.5% ropivacaine by On-Q pain relief system for postoperative pain management after open nephrectomy. Br J Anaesth 2008;101:841-7.
13. Little K, Pillai A, Fazzi U, Storey N. Local anaesthetic infusion with elastomeric pump after arthroscopic subacromial decompression. Ann R Coll Surg Engl 2007;89:410-3. (Pubitemid 46767049)
14. Wheatley GH III, Rosenbaum DH, Paul MC, et al. Improved pain management outcomes with continuous infusion of a local anesthetic after thoracotomy. J Thorac Cardiovasc Surg 2005;130: 464-8. (Pubitemid 41074179)
15. Yoost TR, McIntyre M, Savage SJ. Continuous infusion of local anesthetic decreases narcotic use and length of hospitalization after laparoscopic renal surgery. J Endourol 2009;23:623-6.
16. Klein SM, Evans H, Nielsen KC, et al. Peripheral nerve block techniques for ambulatory surgery. Anesth Analg 2005;101: 1663-76. (Pubitemid 41720618)
17. International Conference on Harmonisation (ICH) Working Group. ICH harmonised tripartite guideline: guideline for good clinical practice E6 (R1). Presented at International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Washington, DC, June 10, 1996. Available at: http://www.ich.org/fileadmin/Public-Web-Site/ICH- Products/Guidelines/Efficacy/E6-R1/Step4/E6-R1--Guideline.pdf. Accessed March 1, 2011.
18. Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth 1995;7:500-6.
19. Langford RM, Chappell GM, Karrasch JA. A single administration of DepoBupivacaine intraoperatively results in prolonged detectable plasma bupivacaine and analgesia in patients undergoing inguinal hernia repair (Abstr). Presented at Annual Postgraduate Assembly in Anesthesiology of the New York State Society of Anesthesiologists, New York, NY, December 12-16, 2008.
20. Abdi H. The Bonferroni and Sidak corrections for multiple comparisons. In: Salkind N, ed. Encyclopedia of Measurement and Statistics. Thousand Oaks, CA: Sage, 2007, pp 1-9.
21. Gutstein HB, Akil H. Opioid analgesics. In: Gutstein HB, Akil H, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. New York, NY: McGraw-Hill, 2001, pp 569-619.
22. United States Food and Drug Administration. Drug approval package. Caldolor (Ibuprofen) Injection 400 mg/4 mL and 800 mg/ 8 mL, Cumberland Pharmaceuticals: Application No. 022348. Updated 2009. Available at: http://www.accessdata.fda.gov/drugsatfda- docs/nda/2009/022348-caldolor-toc.cfm. Accessed April 6, 2011.
23. White PF, Issioui T, Skrivanek GD, et al. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg 2003;97:1303-9. (Pubitemid 37310125)
24. White PF, Rawal S, Latham P, et al. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology 2003;99:918-23. (Pubitemid 37186084)