Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504277
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
The LOw PRESSuRE Trial Laparoscopic Optimization With Pressure Reduction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The LOw PRESSuRE Trial Laparoscopic Optimization With Pressure Reduction Effects on Shoulder-tip Pain Surgical Outcomes and Recovery Enhancement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOw PRESSuRE
Brief Summary:
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 the to standard group or the intervention group low pressure and surgeons will be blinded to study pressure Data on post operative recovery and pain scores will be recorded for each group
Detailed Description:
Primary Objective The primary objective of this study is to determine the effect of low 10 mm Hg versus standard pressure 15 mm Hg pneumoperitoneum on post-operative shoulder pain on post operative day one following laparoscopic gynecologic surgery for benign indication
Secondary Objective Secondary outcomes measured will include post-operative shoulder tip pain at 1 and 2 hours QoR score Appendix A on POD 1 incidence of post-operative shoulder tip pain defined as pain rating above zero at 1 2 and POD 1 generalized pain nausea and bloating at 1 and 2 hours and POD 1 as well as rescue analgesia consumption before discharge and use up to POD1 The investigators will also measure intraoperative time complication rates estimated blood loss surgeon visibility rating and anesthetist satisfaction rating and time to patient discharge Additionally investigators will assess rate of failure to complete the surgery at designated pressure ie request to increase pressure
This proposed study is a single-center 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 Participants will be selected using a convenience sample from Womens College Hospital operating room list All potentially eligible patients will be invited to participate in this study by the MIS fellow on the day of surgery up to 2 hours before the scheduled surgery Study consent will be obtained by the MIS fellow or research assistant after the patient has had sufficient time to consider participation in the study
The INvestigators will create a randomization list using a computer-generated allocation sequence in equal ratio with study numbers 1 to 128 A member of the research team who will have no interaction with patients in this study will prepare the low and standard pressure envelopes and label them according to the randomization list Study participants will be randomized on the day of surgery and the research nurse will set the insufflation pressure to the pre-randomized pressure identified in the envelope The surgeon research team participants and data analysts will be blinded to treatment group Patients will receive standardized peri-operative care during their operation
Post-operative pain nausea and medication use will be assessed in the PACU Patients will also be contacted on POD1 to assess post-operative pain scores calculate total narcotic consumption and elicit any adverse events
Primary Endpoints The primary endpoint is post-operative shoulder tip pain measured on POD 1 following surgery by a self-administered NRS for pain A NRS is a line measuring from 0-10 that rates pain from none 0 though to the worst pain 10 A NRS for subjective pain assessment is a well-established validated measurement tool that has been shown in numerous studies to provide a clinically useful distribution of responses and a detectable treatment effect Clivatti et al 2009
Secondary Endpoints Secondary outcome measures will include a NRS scores for shoulder-tip pain at 1 and 2 hours b QoR score on POD1 c NRS scores for generalized pain at 1 and 2 hours and on POD1 d post operative nausea vomiting and bloating at 1 and 2 hours and on POD1 e narcotic consumption measured as total dose of narcotics in PACU and between discharge and the POD1 phone call f surgical time g estimated blood loss h adverse effectscomplication rates in hospital and reported by the POD1 phone call i surgeon visibility rating and j anesthetist satisfaction rating
Secondary Objective Secondary outcomes measured will include post-operative shoulder tip pain at 1 and 2 hours QoR score Appendix A on POD 1 incidence of post-operative shoulder tip pain defined as pain rating above zero at 1 2 and POD 1 generalized pain nausea and bloating at 1 and 2 hours and POD 1 as well as rescue analgesia consumption before discharge and use up to POD1 The investigators will also measure intraoperative time complication rates estimated blood loss surgeon visibility rating and anesthetist satisfaction rating and time to patient discharge Additionally investigators will assess rate of failure to complete the surgery at designated pressure ie request to increase pressure
This proposed study is a single-center 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 Participants will be selected using a convenience sample from Womens College Hospital operating room list All potentially eligible patients will be invited to participate in this study by the MIS fellow on the day of surgery up to 2 hours before the scheduled surgery Study consent will be obtained by the MIS fellow or research assistant after the patient has had sufficient time to consider participation in the study
The INvestigators will create a randomization list using a computer-generated allocation sequence in equal ratio with study numbers 1 to 128 A member of the research team who will have no interaction with patients in this study will prepare the low and standard pressure envelopes and label them according to the randomization list Study participants will be randomized on the day of surgery and the research nurse will set the insufflation pressure to the pre-randomized pressure identified in the envelope The surgeon research team participants and data analysts will be blinded to treatment group Patients will receive standardized peri-operative care during their operation
Post-operative pain nausea and medication use will be assessed in the PACU Patients will also be contacted on POD1 to assess post-operative pain scores calculate total narcotic consumption and elicit any adverse events
Primary Endpoints The primary endpoint is post-operative shoulder tip pain measured on POD 1 following surgery by a self-administered NRS for pain A NRS is a line measuring from 0-10 that rates pain from none 0 though to the worst pain 10 A NRS for subjective pain assessment is a well-established validated measurement tool that has been shown in numerous studies to provide a clinically useful distribution of responses and a detectable treatment effect Clivatti et al 2009
Secondary Endpoints Secondary outcome measures will include a NRS scores for shoulder-tip pain at 1 and 2 hours b QoR score on POD1 c NRS scores for generalized pain at 1 and 2 hours and on POD1 d post operative nausea vomiting and bloating at 1 and 2 hours and on POD1 e narcotic consumption measured as total dose of narcotics in PACU and between discharge and the POD1 phone call f surgical time g estimated blood loss h adverse effectscomplication rates in hospital and reported by the POD1 phone call i surgeon visibility rating and j anesthetist satisfaction rating
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None