Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery
Primary Purpose
Pelvic Pain, Endometriosis, Pelvic Prolapse
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Pain
Eligibility Criteria
Inclusion Criteria:
- All patients undergoing laparoscopic gynecologic surgery with either the traditional "straight stick" or robotic assisted techniques will be considered for eligibility. Eligible patients will include those with pelvic pain and endometriosis as well as those who present for pelvic floor reconstruction. Surgical procedures performed will include excision of endometriosis, lysis of adhesions, hysterectomy, bilateral or unilateral salpingo-oophorectomy, cystectomy, and pelvic reconstruction.
- Patients who are 18 years or older
- Patients who provide written surgical consent
- Patients who are capable and willing to follow up with surveys and complete pain and pill diaries
Exclusion Criteria:
- Patients who are unable or willing to provide consent and complete the follow up surveys and dairies
- Patients who are allergic to Ropivacaine
- Patients whose minimally invasive procedures were converted to laparotomies
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
0.2 % Ropivacaine
Saline
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Amount of rescue narcotics consumed in the postoperative period, calculated as morphine equivalents.
All rescue oral narcotics taken in the post-operative period will be converted to morphine equivalents and recorded
Secondary Outcome Measures
post-operative pain scores
Pain scores will be obtained via the visual analog scale (VAS). The VAS tool measures pain on a scale from 0 to 10 with 0 being no pain and 10 being unbearable pain.
nausea and vomiting
The postoperative nausea and vomiting impact scale will be used to measure the presence and amount of nausea and vomiting. The scale measures the amount of vomiting from 0 ( no vomiting) to 3 ( three or more episodes of vomiting). The second questions measures the presence of nausea and then the amount from o ( no nausea) to 3 ( all of the time).
Hospital discharge
Time to discharge
Full Information
NCT ID
NCT04118777
First Posted
October 1, 2019
Last Updated
July 13, 2021
Sponsor
University of Tennessee, Chattanooga
1. Study Identification
Unique Protocol Identification Number
NCT04118777
Brief Title
Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery
Official Title
Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery: A Randomized, Double-blind, Placebo-controlled Trial Comparing Continuous Intraperitoneal Infusion of Ropivacaine Versus Saline for Post-operative Pain Control
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Misregistered to wrong sponsor.
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee, Chattanooga
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This will be a prospective, randomized, double blinded placebo-controlled study at Erlanger hospital. Eligible patients who provide consent will be randomized into one of two arms receiving continuous intra-peritoneal local anesthetic with 0.2% Ropivacaine or saline.
Detailed Description
This will be a prospective, randomized, double blinded placebo-controlled study at Erlanger hospital. Eligible patients who provide consent will be randomized into one of two arms receiving continuous intra-peritoneal local anesthetic with 0.2% Ropivacaine or saline. After inclusion criteria are met and consents are obtained all patients will be sent home with a pain measurement, a pill diary to record the quantity of narcotic tablets taken, and a questionnaire nausea and vomiting symptoms.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Endometriosis, Pelvic Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
this will be a double-blinded study. Study participants will be randomized into one of two study arms by the pharmacy staff after using a random number generator.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.2 % Ropivacaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
0.2 % Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr
Primary Outcome Measure Information:
Title
Amount of rescue narcotics consumed in the postoperative period, calculated as morphine equivalents.
Description
All rescue oral narcotics taken in the post-operative period will be converted to morphine equivalents and recorded
Time Frame
6 weeks after surgery
Secondary Outcome Measure Information:
Title
post-operative pain scores
Description
Pain scores will be obtained via the visual analog scale (VAS). The VAS tool measures pain on a scale from 0 to 10 with 0 being no pain and 10 being unbearable pain.
Time Frame
1,2, 4, and 48 hours after surgery. 1 and 2 weeks after surgery
Title
nausea and vomiting
Description
The postoperative nausea and vomiting impact scale will be used to measure the presence and amount of nausea and vomiting. The scale measures the amount of vomiting from 0 ( no vomiting) to 3 ( three or more episodes of vomiting). The second questions measures the presence of nausea and then the amount from o ( no nausea) to 3 ( all of the time).
Time Frame
48 hours, 1 week, and 2 weeks after surgery
Title
Hospital discharge
Description
Time to discharge
Time Frame
post-operative day zero to two
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients undergoing laparoscopic gynecologic surgery with either the traditional "straight stick" or robotic assisted techniques will be considered for eligibility. Eligible patients will include those with pelvic pain and endometriosis as well as those who present for pelvic floor reconstruction. Surgical procedures performed will include excision of endometriosis, lysis of adhesions, hysterectomy, bilateral or unilateral salpingo-oophorectomy, cystectomy, and pelvic reconstruction.
Patients who are 18 years or older
Patients who provide written surgical consent
Patients who are capable and willing to follow up with surveys and complete pain and pill diaries
Exclusion Criteria:
Patients who are unable or willing to provide consent and complete the follow up surveys and dairies
Patients who are allergic to Ropivacaine
Patients whose minimally invasive procedures were converted to laparotomies
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29215508
Citation
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.
Results Reference
background
PubMed Identifier
29112660
Citation
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.
Results Reference
background
PubMed Identifier
28889218
Citation
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.
Results Reference
background
PubMed Identifier
28403427
Citation
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. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
Results Reference
background
PubMed Identifier
28564673
Citation
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.
Results Reference
background
PubMed Identifier
24185607
Citation
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.
Results Reference
background
PubMed Identifier
24327987
Citation
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.
Results Reference
background
PubMed Identifier
15385371
Citation
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.
Results Reference
background
PubMed Identifier
17658017
Citation
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. Erratum In: Obes Surg. 2007 Jul;17(7):996.
Results Reference
background
PubMed Identifier
19335329
Citation
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.
Results Reference
background
PubMed Identifier
21997148
Citation
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.
Results Reference
background
PubMed Identifier
21418466
Citation
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.
Results Reference
background
PubMed Identifier
9215018
Citation
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.
Results Reference
background
PubMed Identifier
27924202
Citation
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.
Results Reference
background
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Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery
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