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

NCT05043844 | Unknown

• 1 other identifier: 2107-220-1240
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

Laparoscopic Surgery; Gynecology

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Intensity of postoperative shoulder pain

  at 12 hours, 24 hours, and 36 hours after surgery

• Shoulder pain depending on posture

  at 12 hours, 24 hours, and 36 hours after surgery

• Surgical site pain

  at 12 hours, 24 hours, and 36 hours after surgery

• Incidence of postoperative nausea and vomiting (PONV)

  at 12 hours, 24 hours, and 36 hours after surgery

• Time of first walking postoperatively

  After transfer to general ward up to 36 hours

Study Arms (2)

Control

NO INTERVENTION

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

Abdominal binder

EXPERIMENTAL

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

Interventions

abdominal binder DEVICE

Wearing an abdominal binder postoperatively

Abdominal binder

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (11)

• 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.

  PMID: 2952160 BACKGROUND

• 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.

  PMID: 26905574 BACKGROUND

• 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.

  PMID: 18448749 BACKGROUND

• Korell M, Schmaus F, Strowitzki T, Schneeweiss SG, Hepp H. Pain intensity following laparoscopy. Surg Laparosc Endosc. 1996 Oct;6(5):375-9.

  PMID: 8890423 BACKGROUND

• 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.

  PMID: 10971421 BACKGROUND

• 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.

  PMID: 17043939 BACKGROUND

• 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.

  PMID: 22184293 BACKGROUND

• 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.

  PMID: 9820719 BACKGROUND

• 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.

  PMID: 23256585 BACKGROUND

• 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.

  PMID: 31996139 BACKGROUND

• 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.

  PMID: 33332919 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hee-Soo Kim, M.D., PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoon Jung KIM

CONTACT

821090886452; imovax4@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 14, 2021
• Study Start: September 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)