Any patient desiring minimally invasive hysterectomy will be contacted by a study team
member during their visit to the MIGS (minimally invasive gynecologic surgery) clinic.
The risks and benefits of participation will be explained to them. If they choose to
participate they will sign the consent form at that time or if they need more time to
consider participation they will sign later. They will then complete the health-related
quality of life (HrQoL) questionnaire UFS-QOL* before surgery.
Computer-generated randomization will be used to randomize patients between 3 groups:
Group A: receiving a continuous infusion of intraperitoneal local anesthetic (LA) during
72 hours
Group B: receiving a continuous infusion of intraperitoneal LA combined with an NSAID
during 72 hours
Group C: receiving a continuous infusion of intraperitoneal placebo during 72 hours.
Study participants will then undergo a minimally invasive hysterectomy by one of the
highly experienced minimally invasive gynecologists using a standard technique. At the
conclusion of the procedure, all women will have an infusion catheter attached to an
ON-Q pump inserted percutaneously into the pelvis under direct laparoscopic vision. The
catheter tip will be placed in the peritoneal cavity at the vaginal vault. In order to
ensure patency of the catheter tubing, a 10 mL bolus of assigned medication will be
given. The ON-Q pump infusion will then provide 540 mL of assigned medication for a
total of 72 hours following surgery.
Surgical variables (length of surgery, estimated blood loss, type of analgesia and
anesthesia used, concomitant procedures, uterine weight, ASA, and intraoperative
complications - organ injury (bladder, bowel, vaginal laceration), EBL > 1000 cc,
conversion to laparotomy, transfusion) will be recorded on a data collection sheet.
Additional analgesia will be administered by the nursing staff in the PACU at the
patient's request. The total dose of analgesia over the 72 postoperative hours will be
calculated for each woman (e.g. each of the following was considered to be one dose; 1 g
of paracetamol, 50 mg diclofenac, 400 mg ibuprofen, 50 mg tramadol). The total morphine
equivalents per patient will also be recorded.
All medication administered for pain as well as VAS pain scores at 1, 2, 4, 6, 24, 48,
and 72 hours postoperatively will be recorded.
Subjects will be discharged when clinically appropriate and according to our usual
hospital procedure, which is usually same day discharge. Subjects staying in hospital
for less than 72 hours will be given verbal and written instructions on catheter
removal.
The subjects will be given a post-operative pain diary to fill out during their 2 week
recovery period including pain scores and amount of pain medication used. This diary
will be collected at their first post-operative visit at around 2 weeks postoperatively.
Subjects will be asked to complete the EQ-5D again during this visit. Postoperative
complications will also be recorded (ICU-admission, reoperation, transfusion, DVT/PE,
readmission, bowel obstruction/ileus, incision
seroma/cellulitis/hematoma/separation/hernia, and cuff
cellulitis/abscess/dehiscence/granulation tissue).
Hospital (operative and pathology reports) and clinical (clinical visit notes) reports
will be reviewed to compare baseline demographics, past surgical history, past medical
history, comorbidities, and complications between groups.
Pumps and syringes will be filled with study drugs depending on the assigned group to a
max of 540 mL for pumps and a max of 10 mL for syringes:
Group A: receiving a continuous infusion of intraperitoneal local anesthetic (LA) during
72 hours: 10 mL bolus of 0.2% Ropivacaine + 540 mL of 0.2% Ropivacaine at 8 mL/hour
infusion
Group B: receiving a continuous infusion of intraperitoneal LA combined with an NSAID
during 72 hours: 10 mL bolus of 0.2% Ropivacaine combined with 30mg/550mL toradol + 540
mL of 0.2% Ropivacaine combined with 30mg/550mL toradol at 8 mL/hour infusion
Group C: receiving a continuous infusion of intraperitoneal placebo during 72 hours: 10
mL bolus of 0.9% normal saline + 540 mL of 0.9% normal saline at 8 mL/hour infusion
The IDS research pharmacist will fill the pumps for use and a member of the research
team will transport the filled pumps to the hospital for the surgeries.
Statistical Analysis: Pre-operative variables such as patient demographic and clinical
information (medical and surgical history) will be recorded and compared as well as
intra-operative variables such as surgical modality, length of surgery, estimated blood
loss, concomitant procedures, uterine weight, ASA, and complications. Before and after
their surgery, patients will complete a questionnaire regarding quality of life and
pain. To combine the results of both sites, REDCap will be used to securely share
de-identified data. These outcome variables will be analyzed by calculating the
unadjusted and adjusted means and 95% confidence intervals using simple and multiple
linear regressions.