Trial Outcomes & Findings for Ultralow Versus Standard Pneumoperitoneum Pressure (NCT NCT03630393)

Results Overview

The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

170 participants

Primary outcome timeframe

Through 1 week postoperatively

Results posted on

2022-02-18

Participant Flow

170 participants were consented/enrolled 31 participants were withdrawn prior to randomization (10 due to coronavirus-19 concerns; 9 due to principal investigator leaving the institution; 5 due to patient request; 3 due to change in eligibility; 3 due to resource availability; 1 at principal investigator request)

Participant milestones

Participant milestones
Measure	Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.	Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.
Overall Study STARTED	68	71
Overall Study COMPLETED	67	71
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.	Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.
Overall Study Death	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pressure 6 mmHg n=68 Participants Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.	Pressure 15 mmHg n=71 Participants Pneumoperitoneum Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.	Total n=139 Participants Total of all reporting groups
Age, Continuous	64.2 years STANDARD_DEVIATION 6.52 • n=68 Participants	62.8 years STANDARD_DEVIATION 6.67 • n=71 Participants	63.5 years STANDARD_DEVIATION 6.61 • n=139 Participants
Sex: Female, Male Female	0 Participants n=68 Participants	0 Participants n=71 Participants	0 Participants n=139 Participants
Sex: Female, Male Male	68 Participants n=68 Participants	71 Participants n=71 Participants	139 Participants n=139 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Through 1 week postoperatively

The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.

Outcome measures

Outcome measures
Measure	Pressure 6 mmHg n=67 Participants Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.	Pressure 15 mmHg n=71 Participants Pneumoperitoneum Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.
Postoperative Pain Medication Use	56.6 morphine milligram equivalents Standard Deviation 40.72	61.2 morphine milligram equivalents Standard Deviation 37.33

SECONDARY outcome

Timeframe: Through discharge (post-operative day 0 or post-operative day 1)

Population: Post-operative pain scores were not recorded for one participant in the Pneumoperitoneum pressure 6 mmHg group

Each participant was asked to rate their pain on a 0-10 scale, with higher numbers representing worse pain. Patients rated their pain at the following time points: in the post-anesthesia care unit (PACU) upon waking from anesthesia, at hours 4, 12, 16, and 20 after transfer to the floor, and immediately prior to discharge. The pain scores for each patient were averaged.

Outcome measures

Outcome measures
Measure	Pressure 6 mmHg n=67 Participants Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.	Pressure 15 mmHg n=71 Participants Pneumoperitoneum Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.
Post Operative Pain Scores	1.4 Units on a scale Standard Deviation 1.61	1.8 Units on a scale Standard Deviation 1.86

SECONDARY outcome

Timeframe: Intraoperatively

Average tidal volume (ml)

Outcome measures

Outcome measures
Measure	Pressure 6 mmHg n=68 Participants Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.	Pressure 15 mmHg n=71 Participants Pneumoperitoneum Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.
Operative Ventilation	629.1 milliliters Standard Deviation 81.9	629.4 milliliters Standard Deviation 83.1

SECONDARY outcome

Timeframe: Through discharge (post-operative day 0 or 1)

Population: The post-operative discharge day was not recorded for one participant in each group

The day of discharge (post-operative day 0 or post-operative day 1) was recorded for each participant

Outcome measures

Outcome measures
Measure	Pressure 6 mmHg n=67 Participants Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.	Pressure 15 mmHg n=70 Participants Pneumoperitoneum Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.
Discharge Day (Post-operative Day 0 or 1) Discharged on Post-operative day 0	56 Participants	62 Participants
Discharge Day (Post-operative Day 0 or 1) Discharged on Post-operative day 1	11 Participants	8 Participants

Adverse Events

Pressure 6 mmHg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Pressure 15 mmHg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pressure 6 mmHg n=68 participants at risk Pneumoperitoneum Pressure 6 mmHg Pneumoperitoneum Pressure 6 mmHg: A pneumoperitoneum insufflation pressure of 6 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.	Pressure 15 mmHg n=71 participants at risk Pneumoperitoneum Pressure 15 mmHg Pneumoperitoneum Pressure 15 mmHg: A pneumoperitoneum insufflation pressure of 15 mmHg will be used during Robotic-assisted laparoscopic prostatectomy.
Gastrointestinal disorders Epigastric bleed	1.5% 1/68 • Number of events 1 • Events were tracked through 90 days following discharge via review of medical records	0.00% 0/71 • Events were tracked through 90 days following discharge via review of medical records

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ryan Hedgepeth

OhioHealth

Phone: 614-788-2870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place