search
Back to results

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

Primary Purpose

Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
abdominal binder
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shoulder Pain focused on measuring Laparoscopic Surgery, Gynecology

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Abdominal binder

Arm Description

In the control group, an investigator performed only a pulmonary recruitment maneuver on the Trendelenburg position before the emergence of anesthesia.

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.

Outcomes

Primary Outcome Measures

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
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
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

Intensity of postoperative shoulder pain
Investigate shoulder pain intensity using numerical rating scale (0-10, 0 representing 'no pain', 10 representing 'worst pain imaginable')
Shoulder pain depending on posture
Investigate whether there is a change in shoulder pain depending on the posture.
Surgical site pain
Investigate Intensity of surgical site pain using numerical rating scale (0-10, 0 representing 'no pain', 10 representing 'worst pain imaginable')
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.
Time of first walking postoperatively
Time of first walking after transfer to general ward

Full Information

First Posted
August 27, 2021
Last Updated
September 5, 2021
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05043844
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Laparoscopic Surgery, Gynecology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
In the control group, an investigator performed only a pulmonary recruitment maneuver on the Trendelenburg position before the emergence of anesthesia.
Arm Title
Abdominal binder
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
abdominal binder
Intervention Description
Wearing an abdominal binder postoperatively
Primary Outcome Measure Information:
Title
Postoperative shoulder pain
Description
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.
Time Frame
Postoperative shoulder pain at 12 hours after surgery
Title
Postoperative shoulder pain
Description
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.
Time Frame
Postoperative shoulder pain at 24 hours after surgery
Title
Postoperative shoulder pain
Description
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.
Time Frame
Postoperative shoulder pain at 36 hours after surgery
Secondary Outcome Measure Information:
Title
Intensity of postoperative shoulder pain
Description
Investigate shoulder pain intensity using numerical rating scale (0-10, 0 representing 'no pain', 10 representing 'worst pain imaginable')
Time Frame
at 12 hours, 24 hours, and 36 hours after surgery
Title
Shoulder pain depending on posture
Description
Investigate whether there is a change in shoulder pain depending on the posture.
Time Frame
at 12 hours, 24 hours, and 36 hours after surgery
Title
Surgical site pain
Description
Investigate Intensity of surgical site pain using numerical rating scale (0-10, 0 representing 'no pain', 10 representing 'worst pain imaginable')
Time Frame
at 12 hours, 24 hours, and 36 hours after surgery
Title
Incidence of postoperative nausea and vomiting (PONV)
Description
The occurrence of PONV is defined as having PONV at least once out of the three measurement time points.
Time Frame
at 12 hours, 24 hours, and 36 hours after surgery
Title
Time of first walking postoperatively
Description
Time of first walking after transfer to general ward
Time Frame
After transfer to general ward up to 36 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoon Jung KIM
Phone
821090886452
Email
imovax4@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Soo Kim, M.D., PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2952160
Citation
Dobbs FF, Kumar V, Alexander JI, Hull MG. Pain after laparoscopy related to posture and ring versus clip sterilization. Br J Obstet Gynaecol. 1987 Mar;94(3):262-6. doi: 10.1111/j.1471-0528.1987.tb02365.x.
Results Reference
background
PubMed Identifier
26905574
Citation
Ko-Iam W, Paiboonworachat S, Pongchairerks P, Junrungsee S, Sandhu T. Combination of etoricoxib and low-pressure pneumoperitoneum versus standard treatment for the management of pain after laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2016 Nov;30(11):4800-4808. doi: 10.1007/s00464-016-4810-4. Epub 2016 Feb 23.
Results Reference
background
PubMed Identifier
18448749
Citation
Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
Results Reference
background
PubMed Identifier
8890423
Citation
Korell M, Schmaus F, Strowitzki T, Schneeweiss SG, Hepp H. Pain intensity following laparoscopy. Surg Laparosc Endosc. 1996 Oct;6(5):375-9.
Results Reference
background
PubMed Identifier
10971421
Citation
Sarli L, Costi R, Sansebastiano G, Trivelli M, Roncoroni L. Prospective randomized trial of low-pressure pneumoperitoneum for reduction of shoulder-tip pain following laparoscopy. Br J Surg. 2000 Sep;87(9):1161-5. doi: 10.1046/j.1365-2168.2000.01507.x.
Results Reference
background
PubMed Identifier
17043939
Citation
Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. doi: 10.1007/s00268-005-0752-z.
Results Reference
background
PubMed Identifier
22184293
Citation
Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
Results Reference
background
PubMed Identifier
9820719
Citation
Berberoglu M, Dilek ON, Ercan F, Kati I, Ozmen M. The effect of CO2 insufflation rate on the postlaparoscopic shoulder pain. J Laparoendosc Adv Surg Tech A. 1998 Oct;8(5):273-7. doi: 10.1089/lap.1998.8.273.
Results Reference
background
PubMed Identifier
23256585
Citation
Das K, Karateke F, Menekse E, Ozdogan M, Aziret M, Erdem H, Cetinkunar S, Ozdogan H, Sozen S. Minimizing shoulder pain following laparoscopic cholecystectomy: a prospective, randomized, controlled trial. J Laparoendosc Adv Surg Tech A. 2013 Mar;23(3):179-82. doi: 10.1089/lap.2012.0410. Epub 2012 Dec 20.
Results Reference
background
PubMed Identifier
31996139
Citation
Zeeni C, Chamsy D, Khalil A, Abu Musa A, Al Hassanieh M, Shebbo F, Nassif J. Effect of postoperative Trendelenburg position on shoulder pain after gynecological laparoscopic procedures: a randomized clinical trial. BMC Anesthesiol. 2020 Jan 29;20(1):27. doi: 10.1186/s12871-020-0946-9.
Results Reference
background
PubMed Identifier
33332919
Citation
Kimura Kuroiwa K, Shiko Y, Kawasaki Y, Aoki Y, Nishizawa M, Ide S, Miura K, Kobayashi N, Sehmbi H. Phrenic Nerve Block at the Azygos Vein Level Versus Sham Block for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Jun 1;132(6):1594-1602. doi: 10.1213/ANE.0000000000005305.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs