Analgesic Effect of Trigger Point Injection and EMLA for Shoulder Pain in Laparoscopic Hysterectomy

Myoma of Uterus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845532
• Other study ID #: 4-2013-0101
• Status: Completed
• Phase: N/A
• First received: April 29, 2013
• Last updated: February 4, 2014
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: February 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. Trigger point injection removes the pain developing point and block the pain signal. EMLA cream shows analgesic effect when being spread on the skin. An literature showed that patch of local anesthetics showed the effect of trigger point inject. The purpose of this study is to investigate the alleviation of shoulder pain, headache, abdominal pain, and back pain after trigger point injection or EMLA cream applying on shoulder in patients undergoing total laparoscopic hysterectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA class I or II

• age 20~70

• patients undergoing total laparoscopic hysterectomy

Exclusion Criteria:

• history of shoulder surgery

• coagulopathy

• infection or trauma of shoulder

• general inflammation

• allergy to local anesthetics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myoma of Uterus

Intervention

Drug:
• TPI
Trigger point injection with 25G needle on the shoulder before surgery(0.5% procaine, 0.25~0.5% lidocaine, 0.125% bupivacaine)
• EMLA cream
EMLA cream with occluding dressing on the shoulder before surgery(5% of eutectic mixture with 2.5% lidocaine and 2.5% prilocaine)

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	postoperative shoulder pain	Postoperative shoulder pain is measured using the VAS at 3 hr after end of surgery.	3 hr after end of surgery	No