Clinical trial NCT06753292: The Influence of Combining the Pulmonary Recruitment Maneuver with Active Gas Aspiration on Post-laparoscopic Shoulder Pain in Patients Having a Gynecologic Laparoscopy, Randomized Double Blinded Clinical Trial
Official title: The Influence of Combining the Pulmonary Recruitment Maneuver with Active Gas Aspiration on Post-laparoscopic Shoulder Pain in Patients Having a Gynecologic Laparoscopy, Randomized Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Laparoscopic Shoulder Pain
Keywords: pulmonary recruitment maneuver
active gas aspiration
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* • Age 18- 65 years.

  * American Society of Anesthesiologists physical status classification (ASA) I - II
  * scheduled for an elective gyncologic laparoscopic procedures

Exclusion Criteria:

* • Urgent or emergency case.

  * ASA classification more than III.
  * Age less than 16 years.
  * Reduced left and right ventricular function (ejection fraction \<40%).
  * Previous respiratory disease such as chronic obstructive pulmonary disease, restrictive lung disease, or had a history of thoracic or shoulder surgery
  * Patient conversion to a laparotomy.
  * the operation time is more than 3 h

Primary outcomes:
measure: post-laparoscopic shoulder pain by VAS score
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Samarah BM, Shehada FA, Qaddumi J, Almasry NA, Alhroub N, ALBashtawy B, Mohammad K, ALBashtawy S, Alkhawaldeh A, ALBashtawy M, Al Omari O, Aljezawi M, Hamadneh S, Suliman M, Hani SB, ALBashtawy Z. The influence of the pulmonary recruitment maneuver on post-laparoscopic shoulder pain in patients having a laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2023 Nov;37(11):8473-8482. doi: 10.1007/s00464-023-10450-x. Epub 2023 Sep 26.
citation: Ryu KH, Lee SH, Cho EA, Kim JA, Lim GE, Song T. Comparison of impacts of intraperitoneal saline instillation with and without pulmonary recruitment maneuver on post-laparoscopic shoulder pain prevention: a randomized controlled trial. Surg Endosc. 2019 Mar;33(3):870-878. doi: 10.1007/s00464-018-6354-2. Epub 2018 Jul 16.
citation: Demouron M, Selvy M, Dembinski J, Mauvais F, Cheynel N, Slim K, Sabbagh C, Regimbeau JM. Feasibility and Effectiveness of an Enhanced Recovery Program after Early Cholecystectomy for Acute Calculous Cholecystitis: A 2-Step Study. J Am Coll Surg. 2022 May 1;234(5):840-848. doi: 10.1097/XCS.0000000000000123.