An interventional study of active gas aspiration and pulmonary recruitment maneuver in Post Laparoscopic Shoulder Pain, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
Laparoscopy is among the most used minimally invasive procedures that can reduce postoperative pain, lessen the duration of hospital stay and facilitate recovery. Laparoscopy has been widely used in various abdominal surgeries, such as gastrectomy, cholecystectomy, appendectomy, hernia and gynecological surgery . However, the post-laparoscopic shoulder pain (PLSP) often occurs following laparoscopic surgeries, and its reported incidence varies from 35-80% This study aims to assess the effect of combining pulmonary recruitment maneuvers (PRM) with active gas aspiration on post-laparoscopic shoulder pain in patients undergoing gynecological laparoscopic procedures.
The PLSP can even remain for up to three days and often upsets the patients . Moreover, it can increase the costs of healthcare owing to an increased usage of analgesics, delayed discharge, and even re-admission .
Therefore, necessary measures should be taken to diminish the intensity of PLSP. Although the exact mechanism of PLSP remains unclear, some studies have suggested that it is caused by the trapping of carbon dioxide (CO2) between the liver and the right diaphragm and subsequent conversion into carbonic acid, which irritates the diaphragm and subsequently generates referred shoulder pain (C4 dermatomal) . Therefore, several studies have attempted to decrease the incidence or severity of PLSP by promoting the removal of remaining CO2 from the abdominal cavity. These efforts include drainage tube insertion, intraperitoneal saline instillation (IPSI), and the usage of intraperitoneal local anesthetic agents . More-over, the pulmonary recruitment maneuver (PRM) can also facilitate the removal of CO2 from the abdominal cavity by increasing positive airway pressure and intrathoracic pressure. PRM is more commonly used in clinical practice because it does not require drugs, specialized apparatus, or additional medical costs, unlike the other methods . Several trials have described the advantages of PRM in patients undergoing laparoscopic operations compared to passive abdominal compression.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Age 18- 65 years.
Exclusion Criteria:
Urgent or emergency case.
The surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas
Procedure: active gas aspiration
The surgeon will be instructed to apply PRM pressures. patients will receive the PRM which consisted of five manual pulmonary inflations,
Procedure: pulmonary recruitment maneuver
surgeon will be instructed to actively aspirate the intraperitoneal CO2 gas
patients will receive the PRM which consisted of five manual pulmonary inflations, where each positive pressure inflation will be done for 5 s at a maximum pressure of 30 cm H2O, manually by using the APL valve in the anesthesia machine. The patient will be in a Trendelenburg position (30°). The fifth positive pressure inflation lasted for approximately 5 s. During that time, the patient will be closely monitored, while the anesthesiologist performed PRM
post-laparoscopic shoulder pain by VAS score
post-laparoscopic shoulder pain by VAS score
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Assiut University