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

August 17, 2020 updated by: Adel Mefleh Abdallah Bataineh, Jordan University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • King Abdullah Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mild Hyperventilation
In this study arm, patients were mildly hyperventilated intraoperatively so their end-tidal CO2 levels are brought down to 30-32 mmHg.
Other: mild intraoperative hyperventilation
Intraoperative mechanical ventilation of patients was adjusted so that end-tidal CO2 readings lie between 30-32 mmHg
No Intervention: Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting
Time Frame: 3 months
The development of nausea and vomiting among patients after laparoscopic sleeve gastrectomy.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Investigators

  • Principal Investigator: Adel M Bataineh, MD, Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2019

Primary Completion (Actual)

February 2, 2020

Study Completion (Actual)

February 2, 2020

Study Registration Dates

First Submitted

August 9, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 17, 2020

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56/124/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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