Pain After Laparoscopic Hysterectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Study group
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria: all of cases that had laparoscopic hysterectomy for bening conditions Exclusion Criteria: maling cases conversion to laparotomy
Sites / Locations
- Namik Kemal University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Washing by heated saline group
Washing by normal room temperature saline group
Arm Description
Outcomes
Primary Outcome Measures
Pain assessed by visual analog scale
To assess postoperative pain incidence by using visual analog scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05784493
First Posted
March 2, 2023
Last Updated
March 13, 2023
Sponsor
Namik Kemal University
Collaborators
Fırat Can Sogut, Ozlem Sevinc Ergul, Mehmet Veysel Arın
1. Study Identification
Unique Protocol Identification Number
NCT05784493
Brief Title
Pain After Laparoscopic Hysterectomy
Official Title
The Effect of Intraabdominal Saline Washing After Laparoscopic Hysterectomy on Postoperative Pain: Double Blind Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Namik Kemal University
Collaborators
Fırat Can Sogut, Ozlem Sevinc Ergul, Mehmet Veysel Arın
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators evaluated postoperative pain after total laparoscopic hysterectomy. Two arm are evaluated. During laparoscopic hysterectomy, in one arm; abdominal cavity was washed by saline at normal room temperature. In another arm; abdominal cavity was washed heated saline . Postoperative pain was evaluated by using visual analogy scale.
Detailed Description
The aim of this study was evaluated the effect of washing abdominal cavity by heated or normal temperature saline on postoperative pain.
This study is double blind randomized controlled study.
inclusion criteria: all of cases that had laparoscopic hysterectomy for bening condition
exclusion criteria: maling cases and conversion to laparotomy
after randomization and completion of surgery, investigator was evaluated postoperative pain at 0-4-8 th hours by using visual analog scale participants and investigator were blinded .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Washing by heated saline group
Arm Type
Experimental
Arm Title
Washing by normal room temperature saline group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Study group
Intervention Description
Washing by heated saline group
Primary Outcome Measure Information:
Title
Pain assessed by visual analog scale
Description
To assess postoperative pain incidence by using visual analog scale
Time Frame
5 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all of cases that had laparoscopic hysterectomy for bening conditions
Exclusion Criteria:
maling cases
conversion to laparotomy
Facility Information:
Facility Name
Namik Kemal University
City
Tekirdag
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Pain After Laparoscopic Hysterectomy
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