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

Not Applicable

Completed

• Conditions: Laparoscopic Gastric Sleeve Surgery; Same Surgeon; ASA-I and II Risk Class Patients
• Interventions: Other: mild intraoperative hyperventilation

• Registration Number: NCT04514887
• Lead Sponsor: Jordan University of Science and Technology

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.

Study Timeline

• Study Start: 2019-06-16
• Primary Completion: 2020-02-02
• Study Completion: 2020-02-02
• Status Verified: 2020-08
• Study First Submitted: 2020-08-09
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-17
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Hyperventilation	mild intraoperative hyperventilation	In this study arm, patients were mildly hyperventilated intraoperatively so their end-tidal CO2 levels are brought down to 30-32 mmHg.

Primary Outcome Measures

Name	Time	Method
Postoperative shoulder Pain	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting	3 months	The development of nausea and vomiting among patients after laparoscopic sleeve gastrectomy.

Trial Locations

Locations (1)

King Abdullah Teaching Hospital; 🇯🇴 Irbid, Jordan