Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery

NCT04118777 | Withdrawn DMC

• 1 other identifier: 123
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Pain; Endometriosis; Pelvic Prolapse

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks after surgery

Secondary Outcomes (3)

• post-operative pain scores

  1,2, 4, and 48 hours after surgery. 1 and 2 weeks after surgery

• nausea and vomiting

  48 hours, 1 week, and 2 weeks after surgery

• Hospital discharge

  post-operative day zero to two

Study Arms (2)

0.2 % Ropivacaine

ACTIVE COMPARATOR

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.

Drug: Ropivacaine

Saline

PLACEBO COMPARATOR

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

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

0.2 % Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr

0.2 % Ropivacaine; Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee, Chattanooga: lead

Related Publications (14)

• 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.

  PMID: 29215508 BACKGROUND

• 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.

  PMID: 29112660 BACKGROUND

• 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.

  PMID: 28889218 BACKGROUND

• 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.

  PMID: 28403427 BACKGROUND

• 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.

  PMID: 28564673 BACKGROUND

• 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.

  PMID: 24185607 BACKGROUND

• 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.

  PMID: 24327987 BACKGROUND

• 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.

  PMID: 15385371 BACKGROUND

• 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.

  PMID: 17658017 BACKGROUND

• 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.

  PMID: 19335329 BACKGROUND

• 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.

  PMID: 21997148 BACKGROUND

• 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.

  PMID: 21418466 BACKGROUND

• 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.

  PMID: 9215018 BACKGROUND

• 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.

  PMID: 27924202 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain; Endometriosis

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 8, 2019
• Study Start: May 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share