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

Not Applicable

• Conditions: Shoulder Pain
• Interventions: Device: abdominal binder

• Registration Number: NCT05043844
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-08-27
• Status Verified: 2021-09
• Study Start: 2021-09
• Study First Submitted QC: 2021-09-05
• Last Update Submitted: 2021-09-05
• Study First Posted: 2021-09-14
• Last Update Posted: 2021-09-14
• Primary Completion: 2022-07
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abdominal binder	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.

Primary Outcome Measures

Name	Time	Method
Postoperative shoulder pain	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.

Secondary Outcome Measures

Name	Time	Method
Surgical site pain	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')
Shoulder pain depending on posture	at 12 hours, 24 hours, and 36 hours after surgery	Investigate whether there is a change in shoulder pain depending on the posture.
Incidence of postoperative nausea and vomiting (PONV)	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.
Time of first walking postoperatively	After transfer to general ward up to 36 hours	Time of first walking after transfer to general ward
Intensity of postoperative shoulder pain	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')

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of