search
Back to results

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Withdrawn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
University of Tennessee, Chattanooga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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.
  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:

  1. Patients who are unable or willing to provide consent and complete the follow up surveys and dairies
  2. Patients who are allergic to Ropivacaine
  3. 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

    First Posted
    October 1, 2019
    Last Updated
    July 13, 2021
    Sponsor
    University of Tennessee, Chattanooga
    search

    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

    Learn more about this trial

    Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery

    We'll reach out to this number within 24 hrs