RecruitingPhase 2ACTRN12621000070831

Investigating the efficacy of a pulmonary recruitment maneuver and closed drainage in reducing shoulder tip pain in women undergoing a total laparoscopic hysterectomy.

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.


Sponsor

St John of God Subiaco Hospital WA

Enrollment

264 participants

Start Date

Jun 21, 2021

Study Type

Interventional

Conditions

Summary

This study will compare four different techniques for reducing the incidence of shoulder tip pain after total laparoscopic hysterectomy. Shoulder tip pain occurs commonly after the procedure and although the exact cause is unknown, it is thought that the carbon dioxide (CO2) gas that is introduced into the abdomen to allow laparoscopic surgery to be performed safely may be the cause. We believe that by combining two techniques - closed drainage and the pulmonary recruitment maneuver - after surgery may allow CO2 gas to be removed more effectively from the abdomen and allow patients to experience less shoulder tip pain than if these techniques are used on their own or not used at all.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After keyhole (laparoscopic) surgery on the uterus, many women experience a surprising and uncomfortable symptom: pain in the shoulder or the tip of the shoulder. This happens because carbon dioxide gas used to inflate the abdomen during surgery can irritate the diaphragm, and this irritation is felt as referred pain in the shoulder. It can last several days and be quite bothersome. This trial is testing whether combining two gas-removal techniques — a "pulmonary recruitment manoeuvre" (where the anaesthetist uses the breathing machine to help expel remaining gas) and "closed drainage" (where the surgical team carefully drains residual gas before closing) — is more effective than using either technique alone or neither technique. Women are randomly assigned to one of four groups. Women aged 18 or older who are having a total laparoscopic hysterectomy (full uterus removal via keyhole surgery) for conditions like heavy periods, fibroids, early uterine cancer, or risk-reducing surgery, with good general health (ASA score 1 or 2) may be eligible. Women who are pregnant, have endometriosis, chronic shoulder pain, severe lung disease, or are not proficient in English are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants that meet the study exclusion inclusion criteria will be randomised into one of four study groups. Group A - Participants will receive the combined treatment of closed drainage for 4 h

Participants that meet the study exclusion inclusion criteria will be randomised into one of four study groups. Group A - Participants will receive the combined treatment of closed drainage for 4 hours and the pulmonary recruitment maneuver. Group B - Participants will receive the single treatment of closed drainage for 4 hours. Group C - Participants will receive the single treatment of the pulmonary recruitment maneuver plus a sham drain. Group D - Participants will receive the current standard of care (no treatment) plus a sham drain. The method of entry into the patient’s abdomen will be left to the discretion of the surgeon. The maximum number of ports allowed to complete the surgery will be four. Only one 10mm port will be allowed. Intraabdominal pressure during the surgical procedure should not exceed 15mmHg and the maximum flow rate should not exceed 40ml/min. Closed Drain method The drain will be administered by the surgeon. A 15cm Blakes drain will be inserted through one of the existing 5mm port sites at the end of the surgery if the patient is randomized to arm A or B of the study. The drain will be placed on low suction, sutured down at its proximal end and removed 4 hours later by the ward nurse. Patient’s randomized to arm C or D of the study will have a sham drain tube placed beneath a strip of sterile gauze taped to the skin, with no intraperitoneal or subcutaneous insertion and removed 4 hours later by the ward nurse. Documentation will be provided to ward staff to ensure awareness of the presence of the sham drain tube. Pulmonary recruitment maneuver The pulmonary recruitment maneuver will be administered by the anaesthetist. The pulmonary recruitment maneuver will involve a series of positive pressure ventilations after the completion of the laparoscopic procedure. It will be restricted to a maximum of five inflations and to a positive ventilation pressure of 40 mmHg, with the patients placed in the Trendelenburg position (30º) and with the laparoscopic ports left open. Post-operative assessment The surgeon will note in the participant’s medical file that the Visual Analogue Scale (VAS) numerical score and 15-item Quality of Recovery questionnaire (QoR-15) are required to be completed approximately 24-36 hours after the start of the operation. The time of completion of these assessments must be clearly recorded on the assessment sheets. A Study Coordinator will approach the participants the day after their operation to provide them with the VAS and QoR-15 for completion. The Study Coordinator will: •Record the details of consultation, including the time, on the computer data sheet assessment (eCRF). The medical records will be used to assess adherence to the interventions. •Book an appointment for follow-up consultation for 6 weeks’ time.


Locations(3)

St John of God Hospital, Subiaco - Subiaco

WA, Australia

Hollywood Private Hospital - Nedlands

WA, Australia

St John of God Hospital, Murdoch - Murdoch

WA, Australia

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ACTRN12621000070831