Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadratus Lumborum (QL) Block | Active Comparator | Patients will receive a bilateral ultrasound guided QL block by the anesthesia team. |
|
| Surgical wound infiltration | Active Comparator | Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivicaine | Drug | Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postoperative day 7 |
| Worst Bloating Severity in the First Postoperative Week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hector Martinez-Wilson, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number of participants in the QL group excludes two subjects-- one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Surgical Wound Infiltration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time) | 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. | Posted | Median | Inter-Quartile Range | oral morphine equivalents in milligrams | 24 hours postoperatively |
|
Up to 7 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hector F. Martinez-Wilson, MD, PhD | Duke University | 919-681-6437 | hector.martinez-wilson@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2022 | Feb 6, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| QL Block | Procedure | Patient will receive ultrasound guided QL Block |
|
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. |
| First seven days postoperatively |
| 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. | First seven days postoperatively |
| Withdrawal by Subject |
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Postoperative day 7 |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | First seven days postoperatively |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | First seven days postoperatively |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided