Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery

Not Applicable

Withdrawn

• Conditions: Endometriosis; Pelvic Pain; Pelvic Prolapse
• Interventions: Drug: Ropivacaine

• Registration Number: NCT04118777
• Lead Sponsor: University of Tennessee, Chattanooga

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.

Study Timeline

• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-08
• Study Start: 2020-05-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.2 % Ropivacaine	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.
Saline	Ropivacaine	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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.
Hospital discharge	post-operative day zero to two	Time to discharge