Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder

September 5, 2021 updated by: Hee-Soo Kim, Seoul National University Hospital

Effect of Abdominal Binder Use on Postoperative Shoulder Pain After Laparoscopic Gynecological Surgery

The aim of the study is to evaluate the effect of the use of an abdominal binder on postoperative shoulder pain according to laparoscopic gynecological surgery. The investigators will compare the incidences of shoulder pain after laparoscopic gynecological surgery in terms of the use of an abdominal binder.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic surgery has advantages over laparotomy in that it reduces postoperative pain and hospital stay. However, postoperative shoulder pain is one of the major concerns of laparoscopic surgery. Shoulder pain has been reported to occur in 35 to 70% of laparoscopic surgeries. The exact mechanism of shoulder pain after laparoscopic surgery is not clear. The main hypothesis is that the presence of residual carbon dioxide (CO2) in the abdominal cavity stimulates the diaphragmatic nerve and causes pain in the shoulder. Alveolar recruitment maneuver in the Trendelenburg position reduced the intensity and incidence of shoulder pain significantly. However, even with these measures, shoulder pain occurred in 63% of patients after surgery. In addition to this measure, The investigators hypothesized that wearing an abdominal binder would promote the absorption of residual CO2 in the abdominal cavity into the peritoneum and pelvis pressure.

The aim of this study was to evaluate the effect of the use of an abdominal binder on shoulder pain after gynecological laparoscopic surgery.

The intraoperative management is carried out in the same manner, except for wearing an abdominal binder after surgery. Laparoscopic procedure is completed, and then intraperitoneal CO2 is passive drained. An anesthetist places the operating table in the Trendelenburg position at 30 degrees and performs the alveolar recruitment maneuver. (CPAP 45 cm H2O is administered 5 times for 7 seconds) In the abdominal binder group, the patient wears an abdominal binder in the Trendelenburg position and then changed to the supine position before the emergence.

In the control group, the patient placed in the supine position, and emergence is started.

Shoulder pain at 12, 24, and 36 hours after surgery is investigated with a Numeric Score Scale (NRS) score.

Study Type

Interventional

Enrollment (Anticipated)

144

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 Contact

Study Locations

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

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult patients aged 20-79 years with ASA I - III undergoing elective laparoscopic gynecological surgery under general anesthesia

Exclusion Criteria:

  • Patients who do not consent to the trial
  • Conversion to open surgery from laparoscopic surgery
  • Patients with previous shoulder disease or history of shoulder surgery
  • Patients who have difficulty wearing an abdominal binder due to skin disease or wounds in the abdomen
  • Development of subcutaneous emphysema
  • Change of intra-abdominal carbon dioxide pressure due to surgical difficulties

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
In the control group, an investigator performed only a pulmonary recruitment maneuver on the Trendelenburg position before the emergence of anesthesia.
Experimental: Abdominal binder
In the abdominal binder group, a pulmonary recruitment maneuver was performed on the Trendelenburg position and the abdominal binder which had a standard height of 22 cm was placed on the abdomen of the patient before the emergence of anesthesia.
Device: abdominal binder
Wearing an abdominal binder postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative shoulder pain
Time Frame: Postoperative shoulder pain at 12 hours after surgery
Investigate occurrence of postoperative shoulder pain at 12 hours, 24 hours, and 36 hours after surgery. The occurrence of shoulder pain is defined as having NRS ≥ 1 pain at least once out of the three measurement time points.
Postoperative shoulder pain at 12 hours after surgery
Postoperative shoulder pain
Time Frame: Postoperative shoulder pain at 24 hours after surgery
Investigate occurrence of postoperative shoulder pain at 12 hours, 24 hours, and 36 hours after surgery. The occurrence of shoulder pain is defined as having NRS ≥ 1 pain at least once out of the three measurement time points.
Postoperative shoulder pain at 24 hours after surgery
Postoperative shoulder pain
Time Frame: Postoperative shoulder pain at 36 hours after surgery
Investigate occurrence of postoperative shoulder pain at 12 hours, 24 hours, and 36 hours after surgery. The occurrence of shoulder pain is defined as having NRS ≥ 1 pain at least once out of the three measurement time points.
Postoperative shoulder pain at 36 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of postoperative shoulder pain
Time Frame: at 12 hours, 24 hours, and 36 hours after surgery
Investigate shoulder pain intensity using numerical rating scale (0-10, 0 representing 'no pain', 10 representing 'worst pain imaginable')
at 12 hours, 24 hours, and 36 hours after surgery
Shoulder pain depending on posture
Time Frame: at 12 hours, 24 hours, and 36 hours after surgery
Investigate whether there is a change in shoulder pain depending on the posture.
at 12 hours, 24 hours, and 36 hours after surgery
Surgical site pain
Time Frame: at 12 hours, 24 hours, and 36 hours after surgery
Investigate Intensity of surgical site pain using numerical rating scale (0-10, 0 representing 'no pain', 10 representing 'worst pain imaginable')
at 12 hours, 24 hours, and 36 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Time Frame: at 12 hours, 24 hours, and 36 hours after surgery
The occurrence of PONV is defined as having PONV at least once out of the three measurement time points.
at 12 hours, 24 hours, and 36 hours after surgery
Time of first walking postoperatively
Time Frame: After transfer to general ward up to 36 hours
Time of first walking after transfer to general ward
After transfer to general ward up to 36 hours

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee-Soo Kim, M.D., PhD, Seoul National University Hospital

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 (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

September 5, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 5, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2107-220-1240

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.

Clinical Trials on Shoulder Pain

Clinical Trials on abdominal binder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe