Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Soonchunhyang University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Soonchunhyang University Hospital
Information provided by (Responsible Party):
Kim Sang-Hyun, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01595165
First received: May 7, 2012
Last updated: July 5, 2012
Last verified: July 2012
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Purpose
Transversus abdominis plane (TAP) block has gained popularity for the control of postoperative pain in various surgeries. Three studies showed inconsistent result on pain control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The investigators are going to investigate the effect of subcostal TAP on early postoperative pain after laparoscopic cholecystectomy.
| Condition | Intervention |
|---|---|
|
Laparoscopic Cholecystectomy Postoperative Pain Abdominal Muscles Nerve Block |
Procedure: Ultrasound guided subcostal TAP block Procedure: Placebo Ultrasound guided subcostal TAP block |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Soonchunhyang University Hospital:
Primary Outcome Measures:
- Numerical Rating Scale (NRS) 15 min after entering recovery room [ Time Frame: 15 min after entering recovery room ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fentanyl consumption at recovery room [ Time Frame: Up to 3 hours until discharge from recovery room ] [ Designated as safety issue: No ]
- Recovery room stay [ Time Frame: Up to 3 hours from entering recovery room to discharge ] [ Designated as safety issue: No ]
- Incidence of postoperative nausea and vomiting (PONV) [ Time Frame: Up to 3 hours during recovery room stay ] [ Designated as safety issue: No ]
- NRS at 4h, 24h, and 48 h after surgery [ Time Frame: 4h, 24h, and 48 h after surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control
Control group receiving saline instead of ropivacaine
|
Procedure: Placebo Ultrasound guided subcostal TAP block
Under ultrasound guidance saline 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.
|
|
Experimental: TAP
TAP group receiving ropivacaine total of 150 mg at TAP under US
|
Procedure: Ultrasound guided subcostal TAP block
Under ultrasound guidance0.375% ropivacaine 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.
|
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ASA I-II
- Age 20-65 patients scheduled elective laparoscopic cholecystectomy
Exclusion Criteria:
- Patient refusal
- Allergy to ropivacaine
- Coagulopathy
- Morbid obesity (BMI>35 kg/m2)
- Previous abdominal surgery.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01595165
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595165
Contacts
| Contact: Sang-Hyun Kim, M.D., Ph.D. | 82-32-621-5328 | skim@schmc.ac.kr |
Locations
| Korea, Republic of | |
| Sang-Hyun Kim | Recruiting |
| Bucheon, Gyeonggi, Korea, Republic of, 420767 | |
| Contact: Sang-Hyun Kim, M.D., Ph.D. 82-32-621-5328 skim@schmc.ac.kr | |
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
| Principal Investigator: | Sang-Hyun Kim, M.D., Ph.D. | Soonchunhyang University Hospital |
More Information
No publications provided
| Responsible Party: | Kim Sang-Hyun, Associate professor, Soonchunhyang University Hospital |
| ClinicalTrials.gov Identifier: | NCT01595165 History of Changes |
| Other Study ID Numbers: | schbcanesthesia |
| Study First Received: | May 7, 2012 |
| Last Updated: | July 5, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Soonchunhyang University Hospital:
|
laparoscopic cholecystectomy ultrasound transversus abdominis plane block |
Additional relevant MeSH terms:
|
Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms |
ClinicalTrials.gov processed this record on March 03, 2015