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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05043844
• Other study ID #: 2107-220-1240
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: Seoul National University Hospital
• Contact: Yoon Jung KIM
• Phone: 821090886452
• Email: imovax4[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: September 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Device:
• abdominal binder
Wearing an abdominal binder postoperatively

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

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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. — View 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. — View 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. — View 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. — View 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. Epub 2016 Feb 23. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time of first walking postoperatively	Time of first walking after transfer to general ward	After transfer to general ward up to 36 hours