Health TrialsbyHealthPanel

Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain

ConditionsSurgeryLaparoscopicLaparoscopyPenumoperitoneumPost-operative PainPost-operative Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMount Sinai Hospital, Canada

About this trial

This proposed study is a single-center, double blind, parallel group RCT comparing the use of low (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum at the time of benign gynecologic laparoscopic surgery. Patients will be randomized to the control group (standard pressure) or the intervention group (low pressure) and surgeons will be blinded to the study pressure. Data on post-operative recovery and pain scores will be recorded for each patient.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

All ages > or = to 18 years old;

Must be deemed to have capacity to provide informed consent;

Must sign and date the informed consent form;

Stated willingness to comply with all study procedures;

Disqualifiers

Previous midline laparotomy;

Gynecological cancer beyond stage 1 disease;

Chronic pain;

Known diagnosis of endometriosis or evidence of endometriosis intra-operatively;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low Pressure Penumoperitoneum

    Procedure/Surgery

    Maintained Pneumoperitoneum with low pressure of 10 mm Hg

  • Standard Pressure Group (No intervention- active comparator)

    Other intervention

    Maintained Pneumoperitoneum at standard pressure of 15 mm Hg

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Standard PressureActive comparator 1 intervention
Group B: Low PressureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Shoulder Tip Pain

The primary endpoint is post-operative shoulder tip pain measured on post-op day 1 following surgery by a self-administered NRS (numeric rating score) for pain, on a scale from 0 (no pain) to 10 (worst pain imaginable).

Time frame
Post-op day 1

Secondary outcomes

1

Shoulder Tip Pain (Short-term)

NRS (numeric rating score) scores for shoulder-tip pain at 1 and 2 hours on a scale from 0 (no pain) to 10 (worst pain imaginable)

Time frame
1 and 2 hours after surgery
2

Quality of Recovery (QoR) score

QoR (Quality of Recovery) score on post-op day 1: a pre-validated score out of 150 (higher score corresponds to better recovery)

Time frame
Post-op day 1
3

Generalized Pain Score

Generalized pain at 1 and 2 hours and on post-op day 1. Self-reported NRS pain score on a scale 0-10.

Time frame
1, 2 hours post-op and post-op day 1
4

Incidence of Nausea and Vomitting

Documented incidence (yes or no) of nausea, vomiting, and bloating at 1 and 2 hours and on post-op day 1. Incidence/presence of nausea and vomiting is worse.

Time frame
1, 2 hours post-op and post-op day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mount Sinai Hospital, Canada

Lead sponsor

Women's College Hospital

Collaborator

Source ClinicalTrials.gov
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