Single-shot TAP Block vs Continuous TAP Block
- Conditions
- Postoperative Pain
- Interventions
- Drug: TAP-SDevice: TAP-C
- Registration Number
- NCT02475031
- Lead Sponsor
- Indiana University
- Brief Summary
The purpose of this study is to determine whether continuous transversus abdominis plane (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor nephrectomy
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group (TAP-S) 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 Active Group (TAP-C) 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
- Primary Outcome Measures
Name Time Method Total Narcotic Usage at 48 Hours 48 hours The primary endpoint of this study will be narcotic requirement at 48 hours
- Secondary Outcome Measures
Name Time Method Sedation Scores at 48 Hours 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.
Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours 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 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 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.
Trial Locations
- Locations (1)
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States