ACTRN12621000070831
Recruiting
Phase 2
A four arm, multi-centered, randomized, blinded, placebo-controlled phase 2 study in gynaecological patients undergoing a total laparoscopic hysterectomy comparing Pulmonary RecruItment Maneuver with closed Drainage vs. closed drainage vs. pulmonary recruitment vs. placebo in reducing shoulder tip pain.
St John of God Subiaco Hospital WA0 sites264 target enrollmentJanuary 28, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- St John of God Subiaco Hospital WA
- Enrollment
- 264
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. All women aged 18 years and over undergoing total laparoscopic hysterectomy
- •2\. American Society of Anesthesilogists (ASA) Score 1 or 2
- •3\. Undergoing a total laparascopic hysterectomy for one of the following conditions:\-
- •1\. Abnormal uterine bleeding.
- •2\.Early stage uterine cancer
- •3\.Atypical hyperplasia
- •4\. Uterine fibroids where the uterine size should not exceed 10cm.
- •5\. Risk reducing surgery
Exclusion Criteria
- •1\.Pregnancy
- •2\.Endometriosis
- •3\.Severe lung disorder
- •4\.Pre\-operative shoulder or neck pain
- •5\.Chronic pelvic pain
- •6\.Severe Cardiovascular disease
- •7\.History of high intracranial pressure
- •8\.Not proficient in English
Outcomes
Primary Outcomes
Not specified
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