Hysterectomy
Conditions
Keywords
TAP block, Liposomal bupivicaine
Brief summary
The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.
Detailed description
All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.
Interventions
DRUGBupivacaine
0.25% bupivacaine for TAP block
DRUGLiposomal bupivacaine
Exparel for TAP block
DRUGSaline
Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patient, surgical team, nursing team, anesthesia team, and outcomes assessor will be blinded to the group assignment. The anesthetist performing the TAP block will not be blinded to the group assignment.
Intervention model description
Patients will be randomized to one of three study groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective open abdominal hysterectomy with midline incision, age \> 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.
Exclusion criteria
* Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) | 0 - 72 hours post-operatively | Total opioid consumption |
| Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given | 0 - 72 hours post-operatively | time to first opioid given |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Local Anesthetic Toxicity | 0 - 72 hours post-operatively | Presence of local anesthetic toxicity |
| Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied | 0 - 72 hours post-operatively | Patient satisfaction post-operatively. The number of patients who were very satisfied is reported. |
| Pain Scores Using Visual Analogue Scale ( 0-10) | 0-24 postoperative pain scores | Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. |
| Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure | 0 - 72 hours post-operatively | Presence of hemodynamic instability |
| Length of Stay in the Hospital | until the patient is discharged from the hospital | Length of stay in the hospital, maximum time until discharge from the hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Bupivacaine: 0.25% bupivacaine for TAP block | 30 |
| Liposomal Bupivacaine Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume. | 30 |
| Liposomal Bupivacaine and Bupivacaine Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Bupivacaine: 0.25% bupivacaine for TAP block
Liposomal bupivacaine: Exparel for TAP block | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine | Total | Bupivacaine | Liposomal Bupivacaine and Bupivacaine |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 90 Participants | 30 Participants | 30 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment United States | 30 participants | 90 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 30 Participants | 90 Participants | 30 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given
time to first opioid given
Time frame: 0 - 72 hours post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given | 51 minutes |
| Liposomal Bupivacaine | Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given | 63 minutes |
| Liposomal Bupivacaine and Bupivacaine | Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given | 51 minutes |
Primary
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
Total opioid consumption
Time frame: 0 - 72 hours post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) | 208 mg morphine equivalents |
| Liposomal Bupivacaine | Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) | 203 mg morphine equivalents |
| Liposomal Bupivacaine and Bupivacaine | Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) | 202 mg morphine equivalents |
Secondary
Length of Stay in the Hospital
Length of stay in the hospital, maximum time until discharge from the hospital
Time frame: until the patient is discharged from the hospital
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Length of Stay in the Hospital | 79 hours |
| Liposomal Bupivacaine | Length of Stay in the Hospital | 82 hours |
| Liposomal Bupivacaine and Bupivacaine | Length of Stay in the Hospital | 80 hours |
Secondary
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure
Presence of hemodynamic instability
Time frame: 0 - 72 hours post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivacaine | Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure | 0 Participants |
| Liposomal Bupivacaine | Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure | 1 Participants |
| Liposomal Bupivacaine and Bupivacaine | Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure | 5 Participants |
Secondary
Number of Patients With Local Anesthetic Toxicity
Presence of local anesthetic toxicity
Time frame: 0 - 72 hours post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivacaine | Number of Patients With Local Anesthetic Toxicity | 0 Participants |
| Liposomal Bupivacaine | Number of Patients With Local Anesthetic Toxicity | 0 Participants |
| Liposomal Bupivacaine and Bupivacaine | Number of Patients With Local Anesthetic Toxicity | 0 Participants |
Secondary
Pain Scores Using Visual Analogue Scale ( 0-10)
Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.
Time frame: 0-24 postoperative pain scores
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Pain Scores Using Visual Analogue Scale ( 0-10) | 8 units on a scale |
| Liposomal Bupivacaine | Pain Scores Using Visual Analogue Scale ( 0-10) | 7 units on a scale |
| Liposomal Bupivacaine and Bupivacaine | Pain Scores Using Visual Analogue Scale ( 0-10) | 7 units on a scale |
Secondary
Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied
Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.
Time frame: 0 - 72 hours post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupivacaine | Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied | 9 participants |
| Liposomal Bupivacaine | Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied | 13 participants |
| Liposomal Bupivacaine and Bupivacaine | Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied | 9 participants |