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

NCT01845532 | Completed

• 1 other identifier: 4-2013-0101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myoma of Uterus

Outcome Measures

Primary Outcomes (1)

• postoperative shoulder pain

  Postoperative shoulder pain is measured using the VAS at 3 hr after end of surgery.

  3 hr after end of surgery

Study Arms (3)

TPI group

EXPERIMENTAL

Drug: TPI

ELMA group

ACTIVE COMPARATOR

Drug: EMLA cream

None group

NO INTERVENTION

Interventions

TPI DRUG

Trigger point injection with 25G needle on the shoulder before surgery(0.5% procaine, 0.25\~0.5% lidocaine, 0.125% bupivacaine)

Also known as: Trigger Point Injection

TPI group

EMLA cream DRUG

EMLA cream with occluding dressing on the shoulder before surgery(5% of eutectic mixture with 2.5% lidocaine and 2.5% prilocaine)

ELMA group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA class I or II
• age 20\~70
• patients undergoing total laparoscopic hysterectomy

You may not qualify if:

• history of shoulder surgery
• coagulopathy
• infection or trauma of shoulder
• general inflammation
• allergy to local anesthetics

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 5, 2014

Record last verified: 2014-02

Locations

KR (1)