Analgesic Effect of Trigger Point Injection and EMLA for Shoulder Pain in Laparoscopic Hysterectomy
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Myoma of Uterus |
| Intervention | Drug: TPI Drug: EMLA cream |
| Phase | N/A |
| Sponsor | Yonsei University |
| Responsible Party | Yonsei University |
| ClinicalTrials.gov Identifier | NCT01845532 |
| First Received | April 29, 2013 |
| Last Updated | February 4, 2014 |
| Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 29, 2013 |
|---|---|
| Last Updated Date | February 4, 2014 |
| Start Date | April 2013 |
| Estimated Primary Completion Date | January 2014 |
| Current Primary Outcome Measures | postoperative shoulder pain [Time Frame: 3 hr after end of surgery] [Designated as safety issue: No]Postoperative shoulder pain is measured using the VAS at 3 hr after end of surgery. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Analgesic Effect of Trigger Point Injection and EMLA for Shoulder Pain in Laparoscopic Hysterectomy |
|---|---|
| Official Title | Not Provided |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention |
| Condition | 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) Other Names: Trigger Point InjectionDrug: EMLA cream EMLA cream with occluding dressing on the shoulder before surgery(5% of eutectic mixture with 2.5% lidocaine and 2.5% prilocaine) |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 75 |
| Estimated Completion Date | January 2014 |
| Estimated Primary Completion Date | November 2013 |
| Eligibility Criteria | 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 |
| Gender | Female |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01845532 |
|---|---|
| Other Study ID Numbers | 4-2013-0101 |
| Has Data Monitoring Committee | No |
| Information Provided By | Yonsei University |
| Study Sponsor | Yonsei University |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | February 2014 |
Locations[ + expand ][ + ]
| Severance hospital | Seoul, Korea, Republic of, 120-752 |
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