Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain

Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain in the Gynecological Laparoscopy

To investigate if the level of preoperative lower back pain has the effect on the acute postoperative pain after gynecological laparoscopy

Study Overview

• Status: Completed
• Conditions: Benign Gynecological Disease

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seocho-gu
    • Seoul, Seocho-gu, Korea, Republic of, 07651
      • Seoul St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

the women scheduled for elective gynecological laparoscopy in the tertiary care clinic

Description

Inclusion Criteria:

• women scheduled for elective gynecological laparoscopy

Exclusion Criteria:

• psychiatric disease eg. anxiety, depression, etc.
• diagnosed as cancer
• the use of vasoactive drug
• chronic pain except lower back pain

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the intensity of acute postoperative pain	The intensity of pain is assessed using the numeric rating scale (0=no pain; 10=the worst pain)	during 30 min in the recovery room

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: Young Eun Moon, MD, PhD, Department of Anesthesiology and Pain Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Back Pain; Low Back Pain
• Other Study ID Numbers: Back Pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No