Completed

NCT Number: NCT04514887

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdullah Teaching Hospital

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mild intraoperative hyperventilation

Other

Intraoperative mechanical ventilation of patients was adjusted so that end-tidal CO2 readings lie between 30-32 mmHg

Primary outcomes

Postoperative shoulder Pain

Time frame: 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 outcomes

Postoperative nausea and vomiting

Time frame: 3 months

The development of nausea and vomiting among patients after laparoscopic sleeve gastrectomy.

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Aug 17, 2020
Registry last updated: Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.