Health TrialsbyHealthPanel

Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

ConditionsHysterectomyGynecologic Surgical ProceduresNarcotic UsePain, Postoperative
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorYing Liu

About this trial

The study is a prospective, double-blinded, placebo-controlled multi-center trial to measure if postoperative pain and the amount of narcotics used are reduced by a clinically significant amount in women undergoing minimally invasive hysterectomy receiving a continuous infusion of intraperitoneal (IP) local anesthetic (LA) or a continuous infusion of LA combined with an NSAID compared with a control group who receives only 0.9% normal saline.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Hysterectomy planned for a benign gynecologic reason (no evidence of, or concern for, malignancy in the cervix, uterus, tubes or ovaries. Benign gynecologic reasons to have a hysterectomy include fibroids, abnormal uterine bleeding, endometriosis, and pelvic pain.)

Patient is scheduled to have surgery with a fellowship trained minimally invasive gynecologic surgeons at one of the study sites.

Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH).

Patient is capable of informed consent.

Disqualifiers

Concern for malignancy

The procedure is scheduled outside MIGS department.

Allergy to any study related medication (i.e. Ketorolac and Ropivacaine)

Patient is enrolled in another pain management study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine Infusion from ON-Q Pump

    Drug

    Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours

  • Ropivacaine + Ketorolac Infusion from ON-Q Pump

    Drug

    Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours

  • Normal Saline Infusion from ON-Q Pump

    Drug

    Infusion of 0.9% normal saline at 8 mL/hour for 72 hours

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: RopivacaineExperimental treatment 1 intervention
Group B: Ropivacaine + KetorolacExperimental treatment 1 intervention
Group C: Normal SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Level 1 Hour Postoperative

Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

Time frame
1 hour postoperative
2

Pain Level 2 Hours Postoperative

Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

Time frame
2 hours postoperative
3

Pain Level 4 Hours Postoperative

Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

Time frame
4 hours postoperative
4

Pain Level 6 Hours Postoperative

Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

Time frame
6 hours postoperative

Secondary outcomes

1

The total dose of analgesics taken over the 72 postoperative hours

Each of the following was considered to be one dose: 1 g of paracetamol, 50 mg diclofenac, 400 mg ibuprofen, 50 mg tramadol

Time frame
Within 72 hours postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ying Liu

Lead sponsor

George Washington University

Sponsor institution

Avanos Medical

Collaborator

Source ClinicalTrials.gov
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