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

Jordan University of Science and Technology

Status: Completed

Conditions: Same Surgeon; Laparoscopic Gastric Sleeve Surgery; ASA-I and II Risk Class Patients

Treatments: Other: mild intraoperative hyperventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT04514887

56/124/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Mild Hyperventilation

Experimental group

Description:

In this study arm, patients were mildly hyperventilated intraoperatively so their end-tidal CO2 levels are brought down to 30-32 mmHg.

Treatment:

Other: mild intraoperative hyperventilation

Control

No Intervention group

Description:

In this study arm patients' ventilation is managed according to guidelines with end-tidal CO2 levels kept in the normal range of 35-40 mm Hg