- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02431065
Ultrasonography-guided and Surgical Rectus Sheath Block in Single-port Access Laparoscopy
Comparing the Analgesic Effects of Ultrasonography-guided and Direct-surgical Rectus Sheath Block in Single-port Access Laparoscopy Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, prospective study comparing the analgesic effects of ultrasonography-guided and direct-surgical rectus sheath block after single-port access laparoscopy in benign ovary cyst patients.
Patients will be randomly divided into 3 groups based on the procedure: control group, ultrasonography group and direct injection group. Each group consists of 30 patients.
Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.
Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.
- Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.
Analgesic efficiency will be assessed using the VAS (visual analogue scale) pain scale and the total amount of self-administered fentanyl via PCA (patient controlled analgesia) devices at multiple time scales (1, 6, 10, 24 and 48 hours after surgery). We will also compare the incidence of fentanyl complications, such as nausea, vomiting, pruritus and dizziness
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Heon Jong Yoo
- Phone Number: 82-42-280-8277
- Email: bell4184@cnuh.co.kr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients scheduled for a single port laparoscopic surgery at Chung Nam University hospital due to benign tumor of the ovary or the fallopian tube
- Between age of twenty to seventy
- Patients with a physical rating of 1 or 2 according to the American Anesthesiology guidelines
- Patients who have not had laparoscopic surgery within two months
Exclusion Criteria:
- Hysterectomy via single port laparoscopic surgery
- Patients with chronic pelvic pain
- Abdominal pain of unknown origin
- Suspected malignant tumor
- Diagnosed with malignant tumor of any origin
- Patients currently taking psychiatric medicine
- Pregnancy
- Patients with a history of hypersensitivity to amide type local anesthetics
- Patients with a history of hypersensitivity to opioid
- Risk of bleeding
- Unable to comprehend or does not agree to the consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 3, Direct injection group
Test group 2, Rectus sheath block will be performed under direct visualization.
Ropivacaine (0.75%, 10ml) will be directly injected into the right and left rectus sheath at the end of the operation.
|
Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:
Other Names:
Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:
Other Names:
|
Active Comparator: Group 2, ultrasonography group
Test group 1, Rectus sheath block will be performed under sonographic guidance.
Ropivacaine (0.75%, 10ml) will be injected into the right and left rectus sheath under ultrasonographic guidance at the end of the operation.
|
Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:
Other Names:
Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:
Other Names:
|
Placebo Comparator: Group 1
Control group, Rectus sheath block will be performed under sonographic guidance.
Normal saline 10 ml will be injected into the right, left rectus sheath under ultrasonography guidance at the end of the operation.
|
Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:
Other Names:
Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The intensity of pain as assessed by Dose of fentanyl(opioid)
Time Frame: within 24 hours of surgery
|
Dose of fentanyl(opioid) self-administered by the patients within 24 hours of surgery
|
within 24 hours of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incident rate of side effects of fentanyl
Time Frame: within 24 hours of surgery
|
Incident rate of side effects of fentanyl including nausea and vomiting by the patients within 24 hours of surgery
|
within 24 hours of surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Heon Jong Yoo, MD. PhD, Chung Nam National University Hospital, clinical vice professor
Publications and helpful links
General Publications
- Crosbie EJ, Massiah NS, Achiampong JY, Dolling S, Slade RJ. The surgical rectus sheath block for post-operative analgesia: a modern approach to an established technique. Eur J Obstet Gynecol Reprod Biol. 2012 Feb;160(2):196-200. doi: 10.1016/j.ejogrb.2011.10.015. Epub 2011 Nov 21.
- Osaka Y, Kashiwagi M, Nagatsuka Y, Oosaku M, Hirose C. [Ultrasound-guided rectus sheath block for upper abdominal surgery]. Masui. 2010 Aug;59(8):1039-41. Japanese.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GyAne-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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