Comparison of Pneumoinsufflation Modes and Pressure Settings in Gynecology
Condition: Pain; Pneumoperitoneum; Inflammation; Quality of Life
MeSH terms: Pneumoperitoneum; Inflammation
Study type: Interventional

Summary: 
      This study seeks to evaluate post-operative patient pain and quality of life, and
      intra-operative hemodynamic status and changes in inflammatory markers, with use of a
      pressure-barrier insufflator and conventional insufflator at high and low pneumoperitoneum
      pressure settings.
    

Detailed description: 
      This is a randomized-controlled double-blinded trial examining outcomes from total
      laparoscopic hysterectomies performed under low and high pressure pneumoperitoneum with
      either a novel pressure-barrier insufflator (AirSeal®) or conventional insufflator. All
      patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be
      screened for eligibility in the study. If eligible, a standard informed consent process will
      ensue.

      All research activities will commence on the day of surgery, in the pre-operative preparation
      area. Enrolled subjects will undergo standard registration and pre-operative preparation by
      the staff preoperative nurse, including placement of intravenous access line and
      administration of standard pre-operative intravenous medications (typically ondansetron,
      dexamethasone, and ketorolac). While in the pre-operative area, and prior to any sedative
      drug administration by anesthesia, the patient will complete an 11-point Numeric Rating Scale
      (NRS) for baseline pain, as well as a baseline 18-question quality of life survey with the
      Abdominal Surgery Impact Scale (ASIS). Both study instruments will be self-administered by
      the patients and collected by the research team. A baseline blood collection will be
      performed in the pre-operative area by the research team assistant and sent for inflammatory
      markers.

      The subject will be moved to the operating room and the anesthesia team will apply the pads
      for use with the Cheetah Non-Invasive Cardiac Output Monitoring (NICOM) system, in addition
      to other standard anesthesia monitoring equipment. The Cheetah NICOM will be activated for
      baseline measurements prior to anesthesia induction. Induction, intubation, and anesthesia
      administration will be performed according to standard practice by a dedicated group of
      anesthesia providers. A second set of hemodynamic measurements from the Cheetah NICOM will be
      measured after intubation, prior to pneumoperitoneum. A select group of anesthesia providers
      familiar with the protocol will administer anesthesia using non-depolarizing muscle relaxants
      continuously adjusted to be no less than one twitch during pneumoperitoneum.

      Prior to any incision, preoperative prophylactic antibiotics and surgical sterile preparation
      will be performed per usual technique. Bilateral upper extremities will be placed in a tucked
      position, and no shoulder pads will be used in any case. An 18g peripheral IV (ideally
      antecubital) will be placed to allow intra-operative blood draws. This may be placed before
      or after anesthesia induction, but prior to arm tucking.

      Randomization will occur after the patient is anesthetized, but prior to surgical start time
      to allow proper equipment to be opened on the surgical field without waste. Randomization
      will be into one of four groups with equal allocation to each (1:1:1:1 ratio):

        1. Conventional insufflation at 15mmHg intra-abdominal pressure. (Group 1)

        2. Conventional insufflation at 9mmHg intra-abdominal pressure (Group 2)

        3. AirSeal® insufflation at 15mmHg intra-abdominal pressure (Group 3)

        4. AirSeal® insufflation at 9mmHg intra-abdominal pressure (Group 4) If randomized to an
           AirSeal® group, the tri-lumen filtered tube set and dedicated access trocar will be
           opened and placed on the surgical field. If randomized to the conventional insufflation
           group, conventional insufflation tubing with an additional conventional trocar will be
           opened and placed on the surgical field. The patient will remain blinded to
           randomization throughout the study, as will the research team assistant responsible for
           blood draws and administration of NRS and ASIS questionnaires.

      Laparoscopic entry will typically be obtained by optical trocar in the periumbilical region,
      but placement may be modified at the surgeon's discretion. Initial pneumoperitoneum will be
      established through this trocar to a pressure of 15mmHg for all groups. Pressure will remain
      at this setting during Trendelenburg positioning and placement of other necessary
      laparoscopic trocars. Data will be recorded for the third time from the Cheetah NICOM at this
      point. Once all trocars are inserted, the AirSeal® system will be activated if necessary
      based on group randomization, and pressure will be decreased to 9mmHg if indicated based on
      randomization. Additional recordings of data from the Cheetah NICOM will occur 10 minutes and
      30 minutes after pressure decrease, and the surgery will proceed according to the surgeon's
      preferred technique. Any surgeon-directed modifications of intra-abdominal pressure at any
      time for surgery completion and/or patient safety will be recorded.

      Thirty minutes after pneumoperitoneum is established, the research team assistant will
      perform the second blood draw for inflammatory markers. The surgery will be completed per
      typical fashion, and total operative time and estimated blood loss will be recorded. A final
      Cheetah NICOM recording will be made 5 minutes after deflation of pneumoperitoneum.

      The patient will emerge from anesthesia under their usual monitoring and be transferred to
      the post-anesthesia care unit (PACU) when meeting appropriate routine criteria. A staff PACU
      nurse will care for the subject in the PACU and administer pain medications as necessary
      and/or per patient request. All pain medication administration in the hospital will be
      recorded in the Epic electronic health record (EHR). The amount of each patient's narcotic
      administration will be recorded from the EHR and documented in study files. The staff PACU
      nurse will be blinded to subject group allocation.

      The research team assistant will administer a NRS pain survey to the patient two hours
      post-operatively and inquire regarding presence of shoulder pain. The third blood draw will
      also occur at this timepoint by the research team assistant. All patients will undergo
      planned same-day discharge to home. If unable to be discharged, they will stay overnight in
      the hospital with documented rationale.

      On the day after surgery, the subject will be contacted by the research team assistant who
      will administer a NRS pain survey by telephone (or in person if still in hospital) and ask
      patient to report number of narcotic pain pills used since discharge and dosage of each.
      Presence of shoulder pain will again be asked. If patient is still in the hospital, narcotic
      usage will be collected from the EHR.

      Per standard routine, the patients will be asked to return to clinic two weeks
      post-operatively for evaluation and examination. The 18-question ASIS will be administered at
      this visit by the blinded research team assistant. If the patient cannot complete the
      "two-week visit" within 1-3 weeks after surgery, the research team assistant will administer
      the ASIS by telephone. The patient will exit the study after this visit. Blinding of the
      patient will be broken after administration of the ASIS, as it is standard practice to
      provide the patient with a copy of the operative report during this visit, which will
      describe the pneumoperitoneum settings used during their case.
    

Intervention name(s): Pneumoinsufflator mode and setting
Intervention type(s): Procedure
Intervention description(s): Patients undergoing total laparoscopic hysterectomy will be randomized to pneumoperitoneum creation by one of two modes (standard or pressure-barrier) at one of two set pressures (15mmHg or 9mmHg) for a four-armed factorial designed study.
Other intervention name(s): Intra-abdominal pressure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: laparoscopy; hysterectomy