Clinical trial NCT04514887: Mild Intraoperative Hyperventilation to Decrease Post-op. Shoulder Pain After LSG
Official title: Intraoperative Mild Hyperventilation as an Intervention to Decrease the Incidence of Postoperative Shoulder Pain After Gastric Sleeve Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Gastric Sleeve Surgery
ASA-I and II Risk Class Patients
Same Surgeon
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Shoulder pain is common after laparoscopic surgeries. multiple maneuvers are in use to decrease its incidence with variable results. This study aims to investigate the effect of mild hyperventilation to an End-tidal CO2 level of 30-32 mmHg on the occurrence of postoperative shoulder pain. This is carried out through a comparison of the incidence of postoperative shoulder pain an intervention group to that in a control one with a normal End Tidal CO2 35-40 mmHg). controlling for all other variables.

Detailed description: This novel technique is based on the theory that shoulder pain is caused by diaphragmatic irritation by CO2 during laparoscopic surgery. The investigators postulate that lowering the CO2 level in the plasma, will lower tissue CO2 level in the diaphragm and decrease the hypothesized irritation. In this study, patients will be divided into an interventional group which will receive mild intraoperative hyperventilation determined by an End-Tidal CO2 level of 30-32 mm Hg and a control group in which End Tidal CO2 is kept at normal levels (35-40 mmHg). All other intraoperative factors will be standardized for all patients. Patients will be followed up postoperatively and asked whether the participants developed shoulder pain as a primary study outcome. The pain will be recorded in terms of severity, site, and position, and any associations (Nausea and vomiting). Appropriate statistical tests will be used to check for any significant effects of the technique.

Eligibility criteria: Inclusion Criteria:

* 18 years old
* No mental illnesses
* American Society of Anesthesiologists (ASA) class I\&II,
* Patients undergoing laparoscopic sleeve gastrectomy.
* No previous intrabdominal surgeries.

Exclusion Criteria:

* ASA class \>II,
* previous abdominal surgeries.
* mental illnesses.

Primary outcomes:
measure: Postoperative shoulder Pain
timeFrame: 3 months
Secondary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: 3 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: King Abdullah Teaching Hospital
Study officials:
affiliation: Jordan University of Science and Technology
name: Adel M Bataineh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sao CH, Chan-Tiopianco M, Chung KC, Chen YJ, Horng HC, Lee WL, Wang PH. Pain after laparoscopic surgery: Focus on shoulder-tip pain after gynecological laparoscopic surgery. J Chin Med Assoc. 2019 Nov;82(11):819-826. doi: 10.1097/JCMA.0000000000000190.
citation: Donatsky AM, Bjerrum F, Gogenur I. Surgical techniques to minimize shoulder pain after laparoscopic cholecystectomy. A systematic review. Surg Endosc. 2013 Jul;27(7):2275-82. doi: 10.1007/s00464-012-2759-5. Epub 2013 Jan 24.
citation: Pergialiotis V, Vlachos DE, Kontzoglou K, Perrea D, Vlachos GD. Pulmonary recruitment maneuver to reduce pain after laparoscopy: a meta-analysis of randomized controlled trials. Surg Endosc. 2015 Aug;29(8):2101-8. doi: 10.1007/s00464-014-3934-7. Epub 2014 Nov 1.
citation: Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.