Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery

University of Tennessee, Chattanooga

Status: Withdrawn

Conditions: Pelvic Prolapse; Pelvic Pain; Endometriosis

Treatments: Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04118777

123

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

0.2 % Ropivacaine

Active Comparator group

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.

Treatment:

Drug: Ropivacaine

Saline

Placebo Comparator group

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

Treatment:

Drug: Ropivacaine