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| ID | Type | Description | Link |
|---|---|---|---|
| GPPG 08-293 |
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The use of bupivacaine , an anesthesic, in laparoscopic portals is recommended in some surgeries. In the ase of tubal ligation by electrocoagulation, where pain is reduced, there is no evidence of this benefit. The objective of this study is to verify the degree of pain after laparoscopic tubal ligation surgery in patient who received bupivacaine 0.5% in the portal, or placebo
In order to conduct this study, the internal and external validation were considered.
The author will use different gynecological teams, with different expertise to perform the laparoscopic tubal ligation, but using the same surgical and anesthesic technique. Second year residents, during their rotation, and medical staff will perform the surgery.
Anesthesic technique:
Intravenous remifentanil 0.1-0.5 micrograms/kg/min Intravenous Propofol target controlled or sevoflurane Intermittent ventilation using O2 40 - 100%, with or without compressed air. Before incision: 5mL of bupivacaine 0.5% or saline solution 0.9% from the aponeurosis until the skin In the end of the procedure: intravenous 4mg of dexamethasone + 40mg of tenoxican
Post-operation prescription:
NPO util well awake, then free according to patient´s tolerance If nausea/vomit: metoclopramide 10mg IV If pain: dipyrone 1g IV qid If pain is intense: morphine 3mg IV 3/3 h If pain persists: morphine 1mg h/h
After hospital discharge:
If pain: sodium diclofenac 50mg tid
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Saline solution 0.9% 5mL in each portal |
|
| 2 | Active Comparator | Bupivacaine 0.5% 5mL in each portal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline solution (laparoscopic tubal ligation) | Drug | 5ml of saline solution in each portal of the trocar (2 portals) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | at 15, 30 and 120 minutes and 14 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Use of medication for pain | at 15, 30 and 120 minutes after surgery and 14 hours later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo F Savaris, MD | HCPA/UFRGS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11452199 | Background | Rioux JE, Daris M. Female sterilization: an update. Curr Opin Obstet Gynecol. 2001 Aug;13(4):377-81. doi: 10.1097/00001703-200108000-00002. | |
| 9389858 | Background | Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 4, 2010 | |
| Reset | Jul 6, 2010 | |
| Release | Jul 7, 2010 | |
| Reset | Aug 4, 2010 | |
| Release | Feb 15, 2011 | |
| Reset | Mar 10, 2011 | |
| Release | Apr 20, 2011 | |
| Reset | May 12, 2011 | |
| Release | Sep 4, 2012 | |
| Reset | Oct 3, 2012 | |
| Release | Aug 19, 2015 | |
| Reset | Sep 21, 2015 | |
| Release | Jun 28, 2017 | |
| Reset | Jan 26, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 4, 2010 | Jul 6, 2010 | |||
| Jul 7, 2010 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Bupivacaine | Drug | 5ml of bupivacaine 0.5% in each trocar portal |
|
| 10960397 | Background | Colbert ST, Moran K, O'Hanlon DM, Chambers F, Moriarty DC, Blunnie WP. An assessment of the value of intraperitoneal meperidine for analgesia postlaparoscopic tubal ligation. Anesth Analg. 2000 Sep;91(3):667-70. doi: 10.1097/00000539-200009000-00032. |
| 8703457 | Background | Curry CS, Darby JR, Janssen BR. Evaluation of pain following electrocautery tubal ligation and effect of intraoperative fentanyl. J Clin Anesth. 1996 May;8(3):216-9. doi: 10.1016/0952-8180(95)00233-2. |
| 158312 | Background | Chi IC, Cole LP. Incidence of pain among women undergoing laparoscopic sterilization by electrocoagulation, the spring-loaded clip, and the tubal ring. Am J Obstet Gynecol. 1979 Oct 1;135(3):397-401. doi: 10.1016/0002-9378(79)90713-0. |
| 20472124 | Derived | Savaris RF, Chicar LL, Cristovam RS, Moraes GS, Miguel OA. Does bupivacaine in laparoscopic ports reduce postsurgery pain in tubal ligation by electrocoagulation? A randomized controlled trial. Contraception. 2010 Jun;81(6):542-6. doi: 10.1016/j.contraception.2009.12.019. Epub 2010 Feb 10. |
| Aug 4, 2010 |
| Feb 15, 2011 | Mar 10, 2011 |
| Apr 20, 2011 | May 12, 2011 |
| Sep 4, 2012 | Oct 3, 2012 |
| Aug 19, 2015 | Sep 21, 2015 |
| Jun 28, 2017 | Jan 26, 2018 |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |