Quadratus Lumborum Block, Surgical Wound Infiltration
Conditions
Keywords
Bupivacaine, Living donor nephrectomy
Brief summary
The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection technique (also called a nerve block) that numbs the nerves going to the abdominal area improve pain control after surgery compared to administration of local anesthetic directly to the surgical incision. The QL block technique uses a numbing solution (local anesthetics) that is injected next to nerves located along muscles in the back to reduce pain. This block will not affect movement in the leg and/or make the legs weak. Some institutions, including Duke, use the QL block for patients having various abdominal surgeries, with the hope of providing good pain relief combined with improved mobility after surgery.
Interventions
Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
PROCEDUREQL Block
Patient will receive ultrasound guided QL Block
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* English speaking * ASA 1-2 patients undergoing living donor nephrectomy
Exclusion criteria
* ASA 3 or 5 * Diagnosis of chronic pain * Daily chronic opioid use (over 3 months of continuous opioid use) * Inability to communicate pain scores or need for analgesia * Infection at the site of block placement * Pregnant women (as determined by standard of care day-of surgery urine bHCG) * Intolerance/allergy to local anesthetics * Weight \<50 kg * Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years * Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance * Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time) | 24 hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Numeric Pain Scores on Postoperative Day Seven | Postoperative day 7 | Pain was measured on a self-reported scale of 0-10, where 0=no pain and 10=worst imaginable pain. Scores were gathered by phone on postoperative day 7. |
| Worst Bloating Severity in the First Postoperative Week | First seven days postoperatively | Bloating severity scores were gathered daily by phone interview for the first week postoperatively. Bloating severity was assessed on a scale of 1-5, where 1= not at all severe and 5=very much. The highest severity score reported during the week was collected for this outcome measure. |
| Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week | First seven days postoperatively | Physical function was assessed by daily phone interview during the first postoperative week. Subjects were asked to assess their ability to go for a walk of at least 15 minute on a scale of 1-5 with 1=unable to do and 5= able to do without any difficulty. For this outcome, the number of subjects who reported being able to go for a walk of at least 15 minutes without any difficulty at any time during the first postoperative week is reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Quadratus Lumborum (QL) Block Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.
QL Block: Patient will receive ultrasound guided QL Block | 22 |
| Surgical Wound Infiltration Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.
Liposomal Bupivicaine: Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound | 20 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Quadratus Lumborum (QL) Block | Total | Surgical Wound Infiltration |
|---|---|---|---|
| Age, Continuous | 42.59 years STANDARD_DEVIATION 14.41 | 45.25 years STANDARD_DEVIATION 13.46 | 47.90 years STANDARD_DEVIATION 12.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 41 Participants | 19 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 | 6 Participants | 10 Participants | 4 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 32 Participants | 16 Participants |
| Region of Enrollment United States | 22 Participants | 42 Participants | 20 Participants |
| Sex: Female, Male Female | 15 Participants | 28 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 20 |
| other Total, other adverse events | 0 / 24 | 0 / 20 |
| serious Total, serious adverse events | 0 / 24 | 0 / 20 |
Outcome results
Primary
Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time)
Time frame: 24 hours postoperatively
Population: This analysis excludes two subjects who were originally enrolled in the QL group--one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Quadratus Lumborum (QL) Block | Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time) | 17.50 oral morphine equivalents in milligrams |
| Surgical Wound Infiltration | Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time) | 21.25 oral morphine equivalents in milligrams |
Comparison: Wilcoxon Rank Sum test performed given non-normal distribution of data by Shapiro Wilks Test. Null hypothesis is that there is no difference in oral morphine equivalent consumption between the two groups in the first 24hrs after surgery. Original sample size calculation based on α=0.05, β=0.8, difference in means=2, and effect size of 1.0.p-value: 0.81Wilcoxon (Mann-Whitney)
Secondary
Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week
Physical function was assessed by daily phone interview during the first postoperative week. Subjects were asked to assess their ability to go for a walk of at least 15 minute on a scale of 1-5 with 1=unable to do and 5= able to do without any difficulty. For this outcome, the number of subjects who reported being able to go for a walk of at least 15 minutes without any difficulty at any time during the first postoperative week is reported.
Time frame: First seven days postoperatively
Population: This analysis excludes two subjects who were originally enrolled in the QL group--one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection. Five subjects (3 in the QL group and 2 in the infiltration group) were not reachable by phone and were therefore excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadratus Lumborum (QL) Block | Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week | 10 Participants |
| Surgical Wound Infiltration | Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week | 12 Participants |
Comparison: Compared using the Likelihood ratio test with α=0.05. The null hypothesis was that there is no difference between the groups.p-value: 0.38Chi-squared
Secondary
Self-reported Numeric Pain Scores on Postoperative Day Seven
Pain was measured on a self-reported scale of 0-10, where 0=no pain and 10=worst imaginable pain. Scores were gathered by phone on postoperative day 7.
Time frame: Postoperative day 7
Population: This analysis excludes two subjects who were originally enrolled in the QL group--one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection. Five subjects (3 in the QL group and 2 in the infiltration group) were not reachable by phone on postoperative day 7 and were therefore excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Quadratus Lumborum (QL) Block | Self-reported Numeric Pain Scores on Postoperative Day Seven | 2 score on a scale |
| Surgical Wound Infiltration | Self-reported Numeric Pain Scores on Postoperative Day Seven | 1 score on a scale |
Comparison: Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference between the two groups in pain on postoperative day 7.p-value: 0.4Wilcoxon (Mann-Whitney)
Secondary
Worst Bloating Severity in the First Postoperative Week
Bloating severity scores were gathered daily by phone interview for the first week postoperatively. Bloating severity was assessed on a scale of 1-5, where 1= not at all severe and 5=very much. The highest severity score reported during the week was collected for this outcome measure.
Time frame: First seven days postoperatively
Population: This analysis excludes two subjects who were originally enrolled in the QL group--one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection. Five subjects (3 in the QL group and 2 in the infiltration group) were not reachable by phone and were therefore excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Quadratus Lumborum (QL) Block | Worst Bloating Severity in the First Postoperative Week | 4 score on a scale |
| Surgical Wound Infiltration | Worst Bloating Severity in the First Postoperative Week | 4 score on a scale |
Comparison: Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference in bloating severity between the two groups.p-value: 0.74Wilcoxon (Mann-Whitney)