Single-shot TAP Block vs Continuous TAP Block (TAP)
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|ClinicalTrials.gov Identifier: NCT02475031|
Recruitment Status : Completed
First Posted : June 18, 2015
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Device: TAP-C Drug: TAP-S||Phase 4|
This study is a randomized, prospective, double blind study comparing single shot versus continuous transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic live donor nephrectomy.
Good pain control after surgery has been shown to decrease complications. To address the problem of postoperative pain control in donor nephrectomy patients,the study investigators began performing Transversus Abdominis Plane (TAP) blocks. The TAP block involves injection of local anesthetic between the abdominal muscle planes (internal oblique muscle and transversus abdominis muscle), to block the somatic nerves that supply sensation to the skin, muscles, and parietal peritoneum of the anterior abdominal wall. Prior reports of TAP blocks have shown that it provides good analgesia for postoperative pain after abdominal surgery. However because the duration of postoperative pain exceeds that of the single shot TAP block, the investigators hypothesized that by placing a catheter through which a continuous infusion of local anesthetic could be delivered, investigators could provide analgesia throughout the postoperative period. The study investigators also hypothesized that improved analgesia would decrease the need for opioid pain medications, hence decreasing the side effects associated with opioid use.
This study is designed to test our hypothesis that placing a TAP catheter is superior to single shot TAP, because it provides a longer duration of analgesia and decreases narcotic use.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Prospective, Double Blind Study Comparing Single Shot Versus Continuous Transverses Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Live Donor Nephrectomy|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Placebo Comparator: Placebo Group (TAP-S)
(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
Catheters with saline infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case.
Other Name: Single shot TAP block
Active Comparator: Active Group (TAP-C)
(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP catheters with ropivacaine infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case.
Other Name: Continuous TAP catheter
- Total Narcotic Usage at 48 Hours [ Time Frame: 48 hours ]The primary endpoint of this study will be narcotic requirement at 48 hours
- Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours [ Time Frame: up to 60 hours ]All narcotic usage will be recorded at 1,12,24,36,48, and 60 hours. All narcotics will be converted to morphine equivalent for statistical calculation. These values reflect the total amount of narcotic used after combining all the data collected from each time point.
- Average Pain Scores [ Time Frame: up to 60 hours ]Post- operative VAS pain scores (range of 0-10. 0 being no pain and 10 being worst pain) will be recorded at 1,12, 24, 36,48 and 60 hours. The values at each time points were combined and averaged.
- Nausea Scores at 48 Hours [ Time Frame: up to 48 hours ]Post-operative nausea scores will be recorded at 48 hours. Range of nausea score is 0-3. 0= None, 1=Mild, 2=Moderate, 3=Severe.
- Sedation Scores at 48 Hours [ Time Frame: 48 hours ]Post-operative sedation scores will be recorded at 48 hours. Range of score is 0-3. 0=Awake and Alert, 1=Quietly Awake, 2=Asleep and Arousable, 3=Deep sleep.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475031
|United States, Indiana|
|Indiana University Hospital|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Yar Yeap, MD||Indiana University Hospital|