Clinical trial NCT05043844: Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder
Official title: Effect of Abdominal Binder Use on Postoperative Shoulder Pain After Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Keywords: Laparoscopic Surgery
Gynecology
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 144
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative shoulder pain
timeFrame: Postoperative shoulder pain at 12 hours after surgery
measure: Postoperative shoulder pain
timeFrame: Postoperative shoulder pain at 24 hours after surgery
measure: Postoperative shoulder pain
timeFrame: Postoperative shoulder pain at 36 hours after surgery
Secondary outcomes:
measure: Intensity of postoperative shoulder pain
timeFrame: at 12 hours, 24 hours, and 36 hours after surgery
measure: Shoulder pain depending on posture
timeFrame: at 12 hours, 24 hours, and 36 hours after surgery
measure: Surgical site pain
timeFrame: at 12 hours, 24 hours, and 36 hours after surgery
measure: Incidence of postoperative nausea and vomiting (PONV)
timeFrame: at 12 hours, 24 hours, and 36 hours after surgery
measure: Time of first walking postoperatively
timeFrame: After transfer to general ward up to 36 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
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