Mild Intraoperative Hyperventilation to Decrease Post-op. Shoulder Pain After LSG

ASA-I and II Risk Class Patients Clinical Trial

Official title:

Intraoperative Mild Hyperventilation as an Intervention to Decrease the Incidence of Postoperative Shoulder Pain After Gastric Sleeve Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514887
• Other study ID #: 56/124/2019
• Status: Completed
• Phase: N/A
• Start date: June 16, 2019
• Est. completion date: February 2, 2020

Study information

• Verified date: August 2020
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ASA-I and II Risk Class Patients
• Hyperventilation
• Laparoscopic Gastric Sleeve Surgery
• Same Surgeon
• Shoulder Pain

Intervention

Other:
• mild intraoperative hyperventilation
Intraoperative mechanical ventilation of patients was adjusted so that end-tidal CO2 readings lie between 30-32 mmHg

Locations

Country	Name	City	State
Jordan	King Abdullah Teaching Hospital	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (4)

Donatsky AM, Bjerrum F, Gögenur 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative shoulder Pain	patient complaining of left of right shoulder pain after laparoscopic sleeve gastrectomy will be evaluated using numerical rating scale, were zero indicates no pain at all, and 10 indicates most severe pain the patient has ever had.	3 months
Secondary	Postoperative nausea and vomiting	The development of nausea and vomiting among patients after laparoscopic sleeve gastrectomy.	3 months