Injection of Local Anesthetic to Trocar Insertion Sites After Laparoscopy
NCT ID: NCT01688596
Last Updated: 2019-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
135 participants
INTERVENTIONAL
2012-09-30
2013-01-31
Brief Summary
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Detailed Description
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Published data regarding the effects of preemptive port site local anesthesia in gynecologic operative laparoscopy have been limited and controversial. Visceral pain control through afferent nerve block could minimize pain perception especially during the first postoperative hours. This study aims to assess the influence of infiltration of local anesthetic to trocar insertion sites after laparoscopic hysterectomy on postoperative pain.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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No Treatment
The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.
No interventions assigned to this group
Bupivacaine
The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.
Bupivacaine
Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Interventions
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Bupivacaine
Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
FEMALE
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Matthew Davies
Professor, Division of Urogynecology and Minimally Invasive GYN Surgery
Principal Investigators
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Gerald Harkins, MD
Role: STUDY_DIRECTOR
Milton S. Hershey Medical Center
Maria Teresa Tam, MD
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Matthew Davies, MD
Role: STUDY_CHAIR
Milton S. Hershey Medical Center
Locations
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Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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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.
Kim JH, Lee YS, Shin HW, Chang MS, Park YC, Kim WY. Effect of administration of ketorolac and local anaesthetic infiltration for pain relief after laparoscopic-assisted vaginal hysterectomy. J Int Med Res. 2005 Jul-Aug;33(4):372-8. doi: 10.1177/147323000503300402.
Saleh A, Fox G, Felemban A, Guerra C, Tulandi T. Effects of local bupivacaine instillation on pain after laparoscopy. J Am Assoc Gynecol Laparosc. 2001 May;8(2):203-6. doi: 10.1016/s1074-3804(05)60578-6.
Ghezzi F, Cromi A, Bergamini V, Raffaelli R, Crotti S, Segredini R, Bolis P. Preemptive port site local anesthesia in gynecologic laparoscopy: a randomized, controlled trial. J Minim Invasive Gynecol. 2005 May-Jun;12(3):210-5. doi: 10.1016/j.jmig.2005.03.007.
Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):545-53. doi: 10.1016/j.jmig.2012.04.002. Epub 2012 Jul 3.
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.
Fong SY, Pavy TJ, Yeo ST, Paech MJ, Gurrin LC. Assessment of wound infiltration with bupivacaine in women undergoing day-case gynecological laparoscopy. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):131-6. doi: 10.1053/rapm.2001.21836.
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.
Salman MA, Yucebas ME, Coskun F, Aypar U. Day-case laparoscopy: a comparison of prophylactic opioid, NSAID or local anesthesia for postoperative analgesia. Acta Anaesthesiol Scand. 2000 May;44(5):536-42. doi: 10.1034/j.1399-6576.2000.00508.x.
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.
Other Identifiers
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40708
Identifier Type: -
Identifier Source: org_study_id
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