Postoperative Pain Score of Laparoscopic Gynecological Surgeries

Postoperative Pain Clinical Trial

Official title:

The Effect of the Umbilicus and Sub-umbilicus Incisions Used in Laparoscopic Gynecological Surgeries on the Postoperative Pain Score

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05296928
• Other study ID #: BaskentU KA21/186
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: December 21, 2022

Study information

• Verified date: July 2022
• Source: Baskent University
• Contact: didem alkas yaginç
• Phone: 05398394853
• Email: didem.alkas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, it was aimed to compare the embryonic route, the umbilicus, and the sub-umbilicus incision in terms of postoperative pain scoring. For this purpose, in laparoscopic hysterectomies performed for benign reasons, it is planned to measure the pain score at the 8th hour and 1st day postoperatively in the umbilicus and subumbilical incision. Visual analog scoring system will be used for pain scoring.

Description:

In this prospective randomized study, Baskent University Adana Dr. Turgut Noyan Application and Research Center for benign reasons (myomas that cause abnormal uterine bleeding, resistant to medical and hysterescopic surgery, treatment-resistant adenomyosis in which the uterus reaches 12 weeks of gestation, recurrent endometrial hyperplasia, endometriosis, stage 1 endometrial cancers that only underwent hysterectomy) in laparoscopic hysterectomies; at the entrance to the abdomen, it is planned to apply the umbilicus, which is the anatomical route, to some of the patients, and to the other part of the sub-umbilicus incision. It will be compared in terms of pain score on the 8th hour and 1st day after surgery. The minimum quorum for each group was determined by calculating 41 and taking a total of 82 patients. The simple randomization technique will be applied in the distribution to the study sets. Based on the studies, it is thought that the anatomical path may be less painful.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: December 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

1. Patients who underwent laparoscopic hysterectomy for benign reasons

2. Stage 1 endometrial cancers that only underwent hysterectomy

Exclusion Criteria:

1. Malign disorders

2. Uterus larger than 12 weeks of gestation

Related Conditions & MeSH terms

• Gynecologic Surgery
• Pain, Postoperative
• Postoperative Pain
• Surgical Incision
• Surgical Wound

Intervention

Procedure:
• laparoscopic incision
laparoscopic umbilical trocar entry pathways

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain score	The umbilicus, which is the embryonic pathway used in laparoscopic surgery, is expected to cause less postoperative pain.In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.	8 hour
Secondary	postoperative pain score after 24 hour	The umbilicus, which is the embryonic pathway used in laparoscopic surgery, is expected to cause less postoperative pain.In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.	24 hour