Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy
Condition: Hysterectomy; Pneumoperitoneum
MeSH terms: Pneumoperitoneum
Study type: Interventional

Summary: 
      With the limited evidence that lower pneumoperitoneum pressures improve postoperative pain in
      laparoscopic or robotic hysterectomy for benign indications, we would like to determine if we
      can both further validate this idea but also show that it has minimal effect on physician
      satisfaction performing the surgery.
    

Detailed description: 
      Minimally invasive hysterectomy, including conventional laparoscopic and robotic-assisted
      hysterectomy, is a commonly performed gynecologic surgery that universally results in
      postoperative pain for patients. Opioid medications are helpful to control postoperative pain
      and are routinely given to women who undergo minimally invasive hysterectomy. However, opioid
      abuse is on the rise in the United States, and there is increased awareness of misuse leading
      to abuse, overdose, and chronic opioid use. In addition to narcotic usage, postoperative pain
      also has negative effects on patient satisfaction and length of stay in the post-anesthesia
      care unit (PACU) leading to potential hospital admission. There is existing evidence that
      reducing the pressure used to create the pneumoperitoneum during laparoscopic surgery may
      affect pain scores that patients endorse in the PACU. Due to improved postoperative pain,
      patients may have decreased opioid use in the PACU and at home, shorter hospital stay, and
      improved overall patient satisfaction. If lower pneumoperitoneum pressures during
      laparoscopic surgery can be shown to reduce postoperative pain, then the ultimate question
      becomes whether there is ability to adapt this practice of using lower pressures to maintain
      pneumoperitoneum. It is unclear whether physician satisfaction will be affected.

      There are several publications investigating the effect of lower pneumoperitoneum pressures
      on postoperative pain. A systematic review in 2016 included 238 patients (three RCTs), showed
      pneumoperitoneum pressures of 8mmHg had a statistically significant although minimal decrease
      in postoperative pain compared to 12mmHg, although lower pressures were associated with worse
      visualization. The authors concluded that the systematic review was inconclusive and further
      studies were necessary. A randomized pilot study with 60 patients comparing low pressure
      (7mmHg) using the AirSeal System versus standard insufflation (15mmHg), showed lower
      postoperative shoulder pain in the group with lower pressure using the AirSeal system. Two
      abstracts in the Journal of Minimally Invasive Gynecology present retrospective studies
      showing decreased postoperative pain with lower pneumoperitoneum pressure. The first abstract
      is from 2015, included a sample size of 170 patients who underwent benign robotic gynecologic
      surgery, 85 patients in each arm (12mmHg and 15mmHg). They showed no difference in median
      recovery time in the PACU and significantly lower median first pain score (5 vs 6, p=.04).
      The second abstract is from 2018 and included a sample size of 598 patients who underwent
      benign robotic gynecologic surgery, 99 patients in 15mmHg arm, 100 patients in 12mmHg arm, 99
      patients in 10mmHg arm, and 300 patients in 8mmHg arm. They showed lower initial pain scores
      with each degree of lower pressure (5.9 vs 5.4 vs 4.4 vs 3.8, p=<.0001) and shorter hospital
      stays with lower pressures. They showed no difference in operative times or blood loss in the
      four arms. Similar studies have been done with cholecystectomy patients that have shown
      improved postoperative shoulder pain with lower pneumoperitoneum pressures. There is also an
      ongoing clinical trial that is still recruiting patients that is studying this similar
      comparison using 9mmHg vs 15mmHg with and without the AirSeal system.

      However, the literature summarized here has never included blinding the intervention of lower
      pneumoperitoneum pressure to the surgeon to determine awareness of pressure and its effect on
      visualization and physician satisfaction.
    

Intervention name(s): Pneumoperitoneum pressure = 15mmHg; Pneumoperitoneum pressure = 12mm Hg; Pneumoperitoneum pressure = 10mmHg
Intervention type(s): Other; Other; Other
Intervention description(s): Randomized pneumoperitoneum 1; Randomized pneumoperitoneum 2; Randomized pneumoperitoneum 3
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three arms including those with pneumoperitoneum pressure of 15mmgHg versus 12mmgHg vs 10 mmHg during laparoscopic or robotic hysterectomy for benign indications.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other