the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01418391
First received: August 16, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
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Purpose
Transversus abdominis plane block (TAP block) is a new regional block for abdominal wall.It had been reported the effect of post-operative pain control in minor abdominal surgery, such as inguinal hernia repair and appendectomy. On the other hand, because of the accurate of the pre-operative images, the minimal laparotomy for colon cancer was accomplished. Thus, the purpose of this study is to investigate the effect, such as analgesic effect, hemodynamic stability, and post-operative morphine consumption, of TAP block in minimal laparotomy.
| Condition | Intervention |
|---|---|
|
Colon Cancer |
Procedure: Transversus Abdominis Plane block |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Primary Outcome Measures:
- amount of post-operative morphine consumption [ Time Frame: post-operative 48 hours ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale [ Time Frame: post-operative 48 hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: morphine consumption |
Procedure: Transversus Abdominis Plane block
TAP BLOCK: dosage form: 0.5% bupivacaine 75mg with 2% xylocaine 300 mg mixed dosage: total 30 ml frequency: single shot duration: 12~18 hours upon to the regional anesthetics choose Other Name: TAP block
|
Detailed Description:
outcome measures:
- Hemodynamic parameters (mean artery pressure, heart rate): recorded at time points of before induction of general anesthesia (baseline), after tracheal intubation immediately, after surgery started 1, 2, 3, 4, 5, 10, 15, 20, 25, and 30 min; then recorded them every 10 mins.
- Post-operative morphine consumption: recorded morphine consumption at the time intervals of post-operative 0~6 h, 6~12 h, 12~24 h, 24~36 h, and 36~48 h ,respectively. The total amount of morphine consumption was also counted.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surger
Exclusion Criteria:
- increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy
- a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418391
Contacts
| Contact: Hung-Te Hsu, VS | +886-7-3121101 ext 7033 | hdhsu1228@hotmail.com |
Locations
| Taiwan | |
| department of anesthesia, Kaohsiung medical university memorial hospital | Recruiting |
| Kaohsiung, Taiwan, 807 | |
| Contact: Hung-Te Hsu, VS +886-7-312-1101 ext 7033 hdhsu1228@hotmail.com | |
| Principal Investigator: Hung-Te Hsu, VS | |
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
| Principal Investigator: | Hung-Te Hsu, VS | Department of anesthesia, Kaoshiung medical university hospital |
More Information
No publications provided
| Responsible Party: | Hung-Te Hsu/ Department of Anesthesia, Kaohsiung Medical University Chung-Ho Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01418391 History of Changes |
| Other Study ID Numbers: | KMUH-IRB-990400, KMUH-IRB-990400 |
| Study First Received: | August 16, 2011 |
| Last Updated: | August 16, 2011 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
|
minimal laparotomy TAP block morphine consumption post-operative analgesia |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013