Pain Characteristics After Total Laparoscopic Hysterectomy

Myoma of Uterus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838382
• Other study ID #: 4-2012-0871
• Status: Completed
• Phase: N/A
• First received: April 16, 2013
• Last updated: January 12, 2014
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Laparoscopic operative procedures have revolutionized gynecological surgery. These have several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter postoperative stay, which cuts down on hospital costs. However, postoperative pain continues to be one complication, which results in an unpleasant experience for the patient and at times causes a delayed discharge. There are few studies about pain characteristics as one of laparoscopic hysterectomy complications. The purpose of this study is to investigate the prevalence and characteristics of shoulder pain, headache, abdominal pain, and back pain in patients undergoing total laparoscopic hysterectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA I or II

• age >=20, <= 80 years

• female

• patients undergoing elective total laparoscopic hysterectomy

Exclusion Criteria:

• age < 19 years or > 80 years

• abnormal mental status

• drug abuse

• chronic alcoholism

• immunosuppressants or steroid user

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myoma of Uterus

Intervention

Device:
• classic LMA insertion
Classic LMA (cLMA) will be inserted when no response is obtained in the train-of-four stimulation. The fiberoptic view through the LMA, intraoperative complications of the cLMA, any complication during anesthesia emergence will be recorded. The device is examined and noted for the presence of visible blood.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall pain	evaluated with visual analogue score (VAS)	3 days	No