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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Shoulder Pain

Intervention / Treatment
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* Device: abdominal binder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>In the control group, an investigator performed only a pulmonary recruitment maneuver on the Trendelenburg position before the emergence of anesthesia. | |
| Experimental: Abdominal binder<br>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<br>* Wearing an abdominal binder postoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative shoulder pain | 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 | 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 | 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 | 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 | 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 | 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) | 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 of first walking after transfer to general ward | After transfer to general ward up to 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Surgery, Gynecology