Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low Pressure Penumoperitoneum, Standard Pressure Group (No intervention- active comparator).
- Who it may be relevant to
- Registry conditions: Surgery, Laparoscopic, Laparoscopy, Penumoperitoneum. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial (RCT) Comparing the Effect of Low Versus Standard Pressure Pneumoperitoneum on Post-operative Shoulder Tip Pain in Patients Undergoing Laparoscopic Gynecologic Surgery for Benign Indications
Overview
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.
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 (i.e. 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 Women's 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 82. 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) to the worst pain imaginable (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 effects/complication rates in hospital and reported by the POD1 phone call (i) surgeon visibility rating and (j) anesthetist satisfaction rating.
Interventions
- Procedure Low Pressure Penumoperitoneum
Maintained Pneumoperitoneum with low pressure of 10 mm Hg - Other Standard Pressure Group (No intervention- active comparator)
Maintained Pneumoperitoneum at standard pressure of 15 mm Hg
Primary outcome measures
- Shoulder Tip Pain [Time frame: Post-op day 1]
Secondary outcome measures (10)
- Shoulder Tip Pain (Short-term) [Time frame: 1 and 2 hours after surgery]
- Quality of Recovery (QoR) score [Time frame: Post-op day 1]
- Generalized Pain Score [Time frame: 1, 2 hours post-op and post-op day 1]
- Incidence of Nausea and Vomitting [Time frame: 1, 2 hours post-op and post-op day 1]
- Narcotic use [Time frame: Post-op day 1]
- Surgical time [Time frame: Duration of surgery (day surgery)]
- Estimated blood loss [Time frame: Duration of surgery (day surgery)]
- Adverse Effect/Complications [Time frame: Post-op day 1]
- Surgeon visibility [Time frame: Duration of surgery]
- Anesthetist satisfaction [Time frame: Duration of surgery]
Eligibility criteria
Inclusion Criteria: The participant must meet all of the inclusion criteria to eligible for this clinical trial:
- 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;
- Must be undergoing unilateral or bilateral salpingo-oopherectomy or salpingectomy or ovarian cystectomy;
Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
- Previous midline laparotomy;
- Gynecological cancer beyond stage 1 disease;
- Chronic pain;
- Known diagnosis of endometriosis or evidence of endometriosis intra-operatively;
- Fibromyalgia;
- BMI >50;
- Language barrier;
- Inability to communicate or provide informed consent;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Women's College Hospital — Toronto
Identifiers
NCT: NCT06504277 · 2023-0008-E