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Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery

Sponsor
University of Tennessee, Chattanooga (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04118777
Collaborator
(none)
0
Enrollment
2
Arms
3
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Jul 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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

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

Outcome Measures

Primary Outcome Measures

  1. Amount of rescue narcotics consumed in the postoperative period, calculated as morphine equivalents. [6 weeks after surgery]

    All rescue oral narcotics taken in the post-operative period will be converted to morphine equivalents and recorded

Secondary Outcome Measures

  1. post-operative pain scores [1,2, 4, and 48 hours after surgery. 1 and 2 weeks after surgery]

    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.

  2. nausea and vomiting [48 hours, 1 week, and 2 weeks after surgery]

    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).

  3. Hospital discharge [post-operative day zero to two]

    Time to discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Tennessee, Chattanooga

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Tennessee, Chattanooga
ClinicalTrials.gov Identifier:
NCT04118777
Other Study ID Numbers:
  • 123
First Posted:
Oct 8, 2019
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Endometriosis
Prolapse
Pelvic Pain
Ropivacaine

Study Results

No Results Posted as of Jul 20, 2021