Clinical trial NCT04125173: Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy
Official title: The Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Pneumoperitoneum
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* female patients
* greater than or equal to 18 years old
* English-speaking
* undergoing laparoscopic or robotic total hysterectomy for benign indications by one of the two minimally invasive gynecologic surgeons at Banner University Medical Center - Phoenix

Exclusion Criteria:

* patients with body max index \>35
* American Society of Anesthesiologists (ASA) score III or IV
* preoperative uterine weight estimated to be greater than 500gm (measured by sonography and using the following formula: length x width x anteroposterior diameter x 0.52)
* patients on chronic opioids for chronic pain (defined as \> 3 months regular opioid use)
* patients who refuse participation in the study
* patients who do not provide informed consent

Primary outcomes:
measure: Physician Satisfaction Part 1
timeFrame: From completion of surgery to one hour postoperative
measure: Physician Satisfaction Part 2
timeFrame: From completion of surgery to one hour postoperative
measure: Physician Satisfaction Part 3
timeFrame: From completion of surgery to one hour postoperative
Secondary outcomes:
measure: Postoperative Pain
timeFrame: From completion of surgery to 24 hours postoperative
measure: Postoperative Shoulder Pain
timeFrame: From completion of surgery to 24 hours postoperative
Other outcomes:
measure: Narcotic usage
timeFrame: From completion of surgery to 24 hours postoperative
measure: Length of hospital stay
timeFrame: From completion of surgery to hospital discharge time up to 7 days
measure: Patient Satisfaction
timeFrame: From completion of surgery to 24 hours postoperative
measure: Intraoperative Respiratory Parameters: Peak inspiratory pressure
timeFrame: From start of surgery to end of surgery
measure: Intraoperative Respiratory Parameters: Tidal volume
timeFrame: From start of surgery to end of surgery
measure: Intraoperative Respiratory Parameters: End tidal CO2
timeFrame: From start of surgery to end of surgery
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: Banner University Medical Center
name: Michael Foley, MD
role: STUDY_CHAIR
References:
citation: Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs Standard Pressures in Gynecologic Laparoscopy: a Systematic Review. JSLS. 2016 Jan-Mar;20(1):e2015.00113. doi: 10.4293/JSLS.2015.00113.
citation: Bogani G, Uccella S, Cromi A, Serati M, Casarin J, Pinelli C, Ghezzi F. Low vs standard pneumoperitoneum pressure during laparoscopic hysterectomy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):466-71. doi: 10.1016/j.jmig.2013.12.091. Epub 2013 Dec 25.
citation: Sroussi J, Elies A, Rigouzzo A, Louvet N, Mezzadri M, Fazel A, Benifla JL. Low pressure gynecological laparoscopy (7mmHg) with AirSeal(R) System versus a standard insufflation (15mmHg): A pilot study in 60 patients. J Gynecol Obstet Hum Reprod. 2017 Feb;46(2):155-158. doi: 10.1016/j.jogoh.2016.09.003. Epub 2017 Jan 30.
citation: 3. Kim DK, Cheong ILY, Lee GY, Cho JH. Low pressure (8 mm Hg) pneumoperitoneum does not reduce the incidence and severity of postoperative nausea and vomiting (PONV) following gynecologic laparoscopy. Korean J Anesthesiol. 2006.
citation: Topcu HO, Cavkaytar S, Kokanali K, Guzel AI, Islimye M, Doganay M. A prospective randomized trial of postoperative pain following different insufflation pressures during gynecologic laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:81-5. doi: 10.1016/j.ejogrb.2014.09.003. Epub 2014 Sep 16.
citation: Nasajiyan N, Javaherfourosh F, Ghomeishi A, Akhondzadeh R, Pazyar F, Hamoonpou N. Comparison of low and standard pressure gas injection at abdominal cavity on postoperative nausea and vomiting in laparoscopic cholecystectomy. Pak J Med Sci. 2014 Sep;30(5):1083-7. doi: 10.12669/pjms.305.5010.