Kidney Donor
Conditions
Brief summary
To evaluate quadratus lumborum block effect on post operative pain scores during the first 24 hours after surgery as compared to transversus abdominis plane block after laparoscopic donor nephrectomy patients.
Interventions
PROCEDUREQL Block
Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
PROCEDURETAP Block
Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Prospective randomized double-blinded trial to compare TAP block versus QL block for pain management in living donor nephrectomy patients. Participants will be blinded to the type of block received and physicians will be blinded both intra- and post-op regarding which block patients received. The team who performs the block will know which block the patient received. No one else involved in the care of the patient will know. The surgery team will not know, and the primary (in the OR) anesthesia team will not know. None of the providers involved in post-operative care of the patient will know.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing laparoscopic assisted donor nephrectomy * Patients that have elected to have a nerve block * 18 years of age or older * Patients of ASA status I - III
Exclusion criteria
* Chronic pain or narcotic usage during the preceding 30 days * Infection at or near the intended needle insertion site * Complex or altered abdominal wall anatomy * Weight \<45kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Score | 24 hours post operative | NRS patient reported (number rated pain score, 0=no pain - 10=highest pain) over the first 24 hours post operative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Cumulative Opioids | 72 hours | opiate consumption first 72 hours post operatively |
| Number of Participants With Nausea or Emesis Requiring Antiemetic Medication | 24 hours | Antiemetics given in PACU. Occurrence of nausea or emesis requiring antiemetic medication administration in PACU. |
| Number of Participants With Block Related Complications | 24 hours | — |
| Length of Stay in Post Anesthesia Care Unit (PACU) | 24 hours | Duration of PACU stay. |
| Length of Hospital Stay | 3 days | The time from surgery completion to subject meeting discharge criterion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| QL Block Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
QL Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. | 24 |
| TAP Block Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
TAP Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | QL Block | Total | TAP Block |
|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 9.39 | 45.8 years STANDARD_DEVIATION 9.7 | 44.6 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 47 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 39 Participants | 20 Participants |
| Region of Enrollment United States | 24 participants | 48 participants | 24 participants |
| Sex: Female, Male Female | 16 Participants | 35 Participants | 19 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Average Pain Score
NRS patient reported (number rated pain score, 0=no pain - 10=highest pain) over the first 24 hours post operative.
Time frame: 24 hours post operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QL Block | Average Pain Score | 5.2 score on a scale | Standard Deviation 2.5 |
| TAP Block | Average Pain Score | 5.1 score on a scale | Standard Deviation 2.6 |
Comparison: An a priori sample size calculation found 24 subjects per group (48 total) provided \>80% power to detect a 2 unit difference in patient reported pain based on a 2-sided test and significance level a = 0.05 assuming at least 3 measures per subject and a within subject covariance having a compound symmetric structure with a standard deviation in pain score of 3 units and within subject correlation of 0.5.p-value: 0.883Mixed Models Analysis
Secondary
Length of Hospital Stay
The time from surgery completion to subject meeting discharge criterion.
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QL Block | Length of Hospital Stay | 1.97 days | Standard Deviation 0.8 |
| TAP Block | Length of Hospital Stay | 1.93 days | Standard Deviation 0.75 |
p-value: 0.719Wilcoxon (Mann-Whitney)
Secondary
Length of Stay in Post Anesthesia Care Unit (PACU)
Duration of PACU stay.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QL Block | Length of Stay in Post Anesthesia Care Unit (PACU) | 79.3 minutes | Standard Deviation 51.7 |
| TAP Block | Length of Stay in Post Anesthesia Care Unit (PACU) | 88.6 minutes | Standard Deviation 31.9 |
p-value: 0.11Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Block Related Complications
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QL Block | Number of Participants With Block Related Complications | 0 Participants |
| TAP Block | Number of Participants With Block Related Complications | 0 Participants |
Secondary
Number of Participants With Nausea or Emesis Requiring Antiemetic Medication
Antiemetics given in PACU. Occurrence of nausea or emesis requiring antiemetic medication administration in PACU.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QL Block | Number of Participants With Nausea or Emesis Requiring Antiemetic Medication | 17 Participants |
| TAP Block | Number of Participants With Nausea or Emesis Requiring Antiemetic Medication | 8 Participants |
p-value: 0.009Chi-squared
Secondary
Total Cumulative Opioids
opiate consumption first 72 hours post operatively
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QL Block | Total Cumulative Opioids | 74.9 morphine milligram equivalents (MME) | Standard Deviation 24.3 |
| TAP Block | Total Cumulative Opioids | 73.7 morphine milligram equivalents (MME) | Standard Deviation 32.1 |
p-value: 0.977ANOVA