Postoperative Pain
Conditions
Keywords
transversus abdominis plane block
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.
Interventions
DEVICETAP-C
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.
DRUGTAP-S
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.
Sponsors
Halyard Health
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy subject undergoing laparoscopic live donor nephrectomy * (ASA) American Society of Anesthesiologists class 1 or 2 * Age 18 or older, male or female * Desires TAP block for postoperative pain control
Exclusion criteria
* Any contraindication for TAP block - single or continuous * History of substance abuse * Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery. * Known allergy or other contraindications to the study medications (Ropivacaine, Normal Saline, Hydromorphone, Oxycodone and Acetaminophen)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Narcotic Usage at 48 Hours | 48 hours | The primary endpoint of this study will be narcotic requirement at 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: 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 Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: 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 Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen | 35 |
| 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: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: 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 Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Active Group (TAP-C) | Placebo Group (TAP-S) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 35 Participants | 70 Participants |
| Age, Continuous | 39.91 years STANDARD_DEVIATION 10.21 | 42.26 years STANDARD_DEVIATION 12.07 | 41.09 years STANDARD_DEVIATION 11.16 |
| Region of Enrollment United States | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Female | 23 Participants | 25 Participants | 48 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Total Narcotic Usage at 48 Hours
The primary endpoint of this study will be narcotic requirement at 48 hours
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group (TAP-S) | Total Narcotic Usage at 48 Hours | 2.44 mg | Standard Error 0.43 |
| Active Group (TAP-C) | Total Narcotic Usage at 48 Hours | 2.88 mg | Standard Error 0.59 |
Secondary
Average Pain Scores
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.
Time frame: up to 60 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group (TAP-S) | Average Pain Scores | 5.31 units on a scale | Standard Error 0.34 |
| Active Group (TAP-C) | Average Pain Scores | 5.06 units on a scale | Standard Error 0.31 |
Secondary
Nausea Scores at 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.
Time frame: up to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group (TAP-S) | Nausea Scores at 48 Hours | 0.34 units on a scale | Standard Error 0.12 |
| Active Group (TAP-C) | Nausea Scores at 48 Hours | 0.34 units on a scale | Standard Error 0.11 |
Secondary
Secondary Endpoints Measured Will be Total Narcotic Usage at 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.
Time frame: up to 60 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group (TAP-S) | Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours | 14.31 mg | Standard Error 2.12 |
| Active Group (TAP-C) | Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours | 14.40 mg | Standard Error 1.73 |
Secondary
Sedation Scores at 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.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group (TAP-S) | Sedation Scores at 48 Hours | 0.2 units on a scale | Standard Error 0.08 |
| Active Group (TAP-C) | Sedation Scores at 48 Hours | 0.06 units on a scale | Standard Error 0.04 |