Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery
NCT ID: NCT04118777
Last Updated: 2021-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-05-01
2020-07-30
Brief Summary
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Detailed Description
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After placement of the ON-Q pain pump the select-a-flow rate will be set to 6 mL/hr for all study participants. . All study participants will be provided with rescue pain medications as needed. If possible non-narcotic medications such as Tylenol and non-steroidal anti-inflammatory's will be utilized first. If pain persists narcotic medications will be provided. Oxycodone 5 mg will be utilized unless a patient reported allergy exists. All rescue narcotics utilized will be converted into morphine equivalents and documented. All patients will be discharged with Oxycodone 5 mg with 35 tablets which provides pain coverage for 7 days after surgery. In addition to Oxycodone all patients will be discharged with Sprix, a nasal non-steroidal anti-inflammatory medication, as well as Zofran and movantik, a medication for narcotic induced constipation. All patients will be instructed to administer Sprix by placing one puff into each nostril every 6 hours for a total of 5 days after surgery. They will further be instructed to take oral Tylenol 1000 mg every 6 hours for a total of 4 days after surgery. Assigned research personnel will contact all patients to obtain the results of their survey and pill dairy at 48 hours and one week after surgery. Patients will then present for a two-week post-operative visit where study personnel will complete data collection. All study participants who request a narcotic refill within 6 weeks of surgery will be documented.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.2 % Ropivacaine
An ON-Q pain pump will be placed into the pelvic cavity and 0.2% Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr.
Ropivacaine
0.2 % Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr
Saline
An ON-Q pain pump will be placed into the pelvic cavity and saline will be continuously administered intraperitoneally at a rate of 6 mL/hr
Ropivacaine
0.2 % Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr
Interventions
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Ropivacaine
0.2 % Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr
Eligibility Criteria
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Inclusion Criteria
2. Patients who are 18 years or older
3. Patients who provide written surgical consent
4. Patients who are capable and willing to follow up with surveys and complete pain and pill diaries
Exclusion Criteria
2. Patients who are allergic to Ropivacaine
3. Patients whose minimally invasive procedures were converted to laparotomies
18 Years
65 Years
FEMALE
Yes
Sponsors
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University of Tennessee, Chattanooga
OTHER
Responsible Party
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References
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Madsen AM, Stark LM, Has P, Emerson JB, Schulkin J, Matteson KA. Opioid Knowledge and Prescribing Practices Among Obstetrician-Gynecologists. Obstet Gynecol. 2018 Jan;131(1):150-157. doi: 10.1097/AOG.0000000000002407.
As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
Hota LS, Warda HA, Haviland MJ, Searle FM, Hacker MR. Opioid use following gynecologic and pelvic reconstructive surgery. Int Urogynecol J. 2018 Oct;29(10):1441-1445. doi: 10.1007/s00192-017-3474-5. Epub 2017 Sep 9.
Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
Perniola A, Fant F, Magnuson A, Axelsson K, Gupta A. Postoperative pain after abdominal hysterectomy: a randomized, double-blind, controlled trial comparing continuous infusion vs patient-controlled intraperitoneal injection of local anaesthetic. Br J Anaesth. 2014 Feb;112(2):328-36. doi: 10.1093/bja/aet345. Epub 2013 Oct 31.
Chung D, Lee YJ, Jo MH, Park HJ, Lim GW, Cho H, Nam EJ, Kim SW, Kim JH, Kim YT, Kim S. The ON-Q pain management system in elective gynecology oncologic surgery: Management of postoperative surgical site pain compared to intravenous patient-controlled analgesia. Obstet Gynecol Sci. 2013 Mar;56(2):93-101. doi: 10.5468/OGS.2013.56.2.93. Epub 2013 Mar 12.
Gupta A, Perniola A, Axelsson K, Thorn SE, Crafoord K, Rawal N. Postoperative pain after abdominal hysterectomy: a double-blind comparison between placebo and local anesthetic infused intraperitoneally. Anesth Analg. 2004 Oct;99(4):1173-1179. doi: 10.1213/01.ANE.0000130260.24433.A2.
Cottam DR, Fisher B, Atkinson J, Link D, Volk P, Friesen C, Link D, Grace B, Trovar R. A randomized trial of bupivicaine pain pumps to eliminate the need for patient controlled analgesia pumps in primary laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2007 May;17(5):595-600. doi: 10.1007/s11695-007-9103-5.
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 Apr;23(4):623-6. doi: 10.1089/end.2008.0586.
Thornton PC, Buggy DJ. Local anaesthetic wound infusion for acute postoperative pain: a viable option? Br J Anaesth. 2011 Nov;107(5):656-8. doi: 10.1093/bja/aer293. No abstract available.
Kahokehr A, Sammour T, Soop M, Hill AG. Intraperitoneal local anaesthetic in abdominal surgery - a systematic review. ANZ J Surg. 2011 Apr;81(4):237-45. doi: 10.1111/j.1445-2197.2010.05573.x. Epub 2010 Nov 17.
Williamson KM, Cotton BR, Smith G. Intraperitoneal lignocaine for pain relief after total abdominal hysterectomy. Br J Anaesth. 1997 Jun;78(6):675-7. doi: 10.1093/bja/78.6.675.
Lee SH, Sim WS, Kim GE, Kim HC, Jun JH, Lee JY, Shin BS, Yoo H, Jung SH, Kim J, Lee SH, Yo DK, Na YR. Randomized trial of subfascial infusion of ropivacaine for early recovery in laparoscopic colorectal cancer surgery. Korean J Anesthesiol. 2016 Dec;69(6):604-613. doi: 10.4097/kjae.2016.69.6.604. Epub 2016 Sep 28.
Other Identifiers
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123
Identifier Type: -
Identifier Source: org_study_id
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