Hysterectomy
Conditions
Brief summary
The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a hysterectomy surgery. By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (nausea, sedation, ileus, urinary retention, respiratory depression).
Detailed description
For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected. \[10\] For the ESP block, as mentioned previously, the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected. All patients will receive PO acetaminophen and PO gabapentin the morning of surgery. Pt. will be placed on PRN oxycodone/acetaminophen (Percocet) postoperatively. PRN IV dilaudid may be given for severe breakthrough pain. Opioid usage at 1, 24 and 48 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24 and 48 hours after the blocks and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded.
Interventions
DRUGLiposomal bupivacaine
20ml
DRUGbupivacaine, 0.125%
60ml
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Both the patients and the research staff doing assessments will be blinded to the randomization
Intervention model description
1. ESP Block Group 2. TAP Block Group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing laparoscopic hysterectomy surgery at Indiana University Hospital * ASA class 1, 2, 3 or 4 * Age 18 or older, female * Desires Regional anesthesia for postoperative pain control
Exclusion criteria
* History of substance abuse in the past 6 months. * Patients on more than 30 mg morphine equivalents of opioids. * 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 (Acetaminophen, Gabapentin, Bupivacaine). * Postoperative intubation. * Any BMI greater than 40.0.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour. | 1 hour after surgery | Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10) |
| Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours. | 24 hours after surgery | Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain (scale 0-10) |
| Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours. | 48 hours after surgery | Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain(scale 0-10) |
| Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour. | 1 hour after surgery | Visual Analogue Scale (VAS) score taken with movement is measured as minimal to maximal; higher values mean worse pain (scale 0-10) |
| Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours. | 24 hours after surgery | Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain (scale 0-10) |
| Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours. | 48 hours after surgery | Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain(scale 0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Score at 24 Hours | 24 hours after surgery | patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied) |
| Patient Sedation Score at 1 Hour | 1 hour after surgery | Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep) |
| Patient Satisfaction Score at 48 Hours | 48 hours after surgery | patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied) |
| Patient Sedation Score at 24 Hours | 24 hours after surgery | Sedation is measured as minimum to maximum aware ness/level of consciousness: higher values means worse or less awareness (awake, asleep but arousable, deep sleep) |
| Patient Sedation Score at 48 Hours | 48 hours after surgery | Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep) |
| Patient Nausea Score at 1 Hour | 1 hour after surgery | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) |
| Patient Nausea Score at 24 Hour | 24 hour after surgery | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) |
| Patient Nausea Score at 48 Hour | 48 hour after surgery | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ESP Block For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12)
Liposomal bupivacaine: 20ml
bupivacaine, 0.125%: 60ml | 39 |
| TAP Block For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP).
Liposomal bupivacaine: 20ml
bupivacaine, 0.125%: 60ml | 39 |
| Total | 78 |
Baseline characteristics
| Characteristic | TAP Block | Total | ESP Block |
|---|---|---|---|
| Age, Categorical <=18 years | 39 Participants | 78 Participants | 39 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 42.7 years STANDARD_DEVIATION 1.8 | 44.9 years STANDARD_DEVIATION 1.3 | 47.1 years STANDARD_DEVIATION 1.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 39 participants | 78 participants | 39 participants |
| Sex: Female, Male Female | 39 Participants | 78 Participants | 39 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour.
Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Time frame: 1 hour after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESP Block | Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour. | 2.8 score on a scale | Standard Error 0.5 |
| TAP Block | Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour. | 3 score on a scale | Standard Error 0.4 |
Primary
Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours.
Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESP Block | Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours. | 3 score on a scale | Standard Error 0.4 |
| TAP Block | Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours. | 2.8 score on a scale | Standard Error 0.4 |
Primary
Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours.
Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain(scale 0-10)
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESP Block | Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours. | 2.1 score on a scale | Standard Error 0.4 |
| TAP Block | Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours. | 2 score on a scale | Standard Error 0.3 |
Primary
Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour.
Visual Analogue Scale (VAS) score taken with movement is measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Time frame: 1 hour after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESP Block | Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour. | 3 score on a scale | Standard Error 0.5 |
| TAP Block | Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour. | 3.5 score on a scale | Standard Error 0.4 |
Primary
Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours.
Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESP Block | Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours. | 4.3 score on a scale | Standard Error 0.4 |
| TAP Block | Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours. | 4.1 score on a scale | Standard Error 0.4 |
Primary
Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours.
Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain(scale 0-10)
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESP Block | Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours. | 3.4 score on a scale | Standard Error 0.4 |
| TAP Block | Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours. | 3.2 score on a scale | Standard Error 0.3 |
Secondary
Patient Nausea Score at 1 Hour
Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)
Time frame: 1 hour after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESP Block | Patient Nausea Score at 1 Hour | Yes | 5 Participants |
| ESP Block | Patient Nausea Score at 1 Hour | No | 33 Participants |
| TAP Block | Patient Nausea Score at 1 Hour | Yes | 6 Participants |
| TAP Block | Patient Nausea Score at 1 Hour | No | 33 Participants |
Secondary
Patient Nausea Score at 24 Hour
Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)
Time frame: 24 hour after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESP Block | Patient Nausea Score at 24 Hour | Yes | 11 Participants |
| ESP Block | Patient Nausea Score at 24 Hour | No | 25 Participants |
| TAP Block | Patient Nausea Score at 24 Hour | Yes | 7 Participants |
| TAP Block | Patient Nausea Score at 24 Hour | No | 32 Participants |
Secondary
Patient Nausea Score at 48 Hour
Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)
Time frame: 48 hour after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESP Block | Patient Nausea Score at 48 Hour | Yes | 2 Participants |
| ESP Block | Patient Nausea Score at 48 Hour | No | 33 Participants |
| TAP Block | Patient Nausea Score at 48 Hour | Yes | 7 Participants |
| TAP Block | Patient Nausea Score at 48 Hour | No | 32 Participants |
Secondary
Patient Satisfaction Score at 24 Hours
patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied)
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESP Block | Patient Satisfaction Score at 24 Hours | 3.7 score on a scale | Standard Error 0.1 |
| TAP Block | Patient Satisfaction Score at 24 Hours | 3.6 score on a scale | Standard Error 0.1 |
Secondary
Patient Satisfaction Score at 48 Hours
patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied)
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESP Block | Patient Satisfaction Score at 48 Hours | 3.7 score on a scale | Standard Error 0.1 |
| TAP Block | Patient Satisfaction Score at 48 Hours | 3.7 score on a scale | Standard Error 0.1 |
Secondary
Patient Sedation Score at 1 Hour
Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep)
Time frame: 1 hour after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESP Block | Patient Sedation Score at 1 Hour | Sleep | 15 Participants |
| ESP Block | Patient Sedation Score at 1 Hour | Awake | 23 Participants |
| TAP Block | Patient Sedation Score at 1 Hour | Sleep | 15 Participants |
| TAP Block | Patient Sedation Score at 1 Hour | Awake | 24 Participants |
Secondary
Patient Sedation Score at 24 Hours
Sedation is measured as minimum to maximum aware ness/level of consciousness: higher values means worse or less awareness (awake, asleep but arousable, deep sleep)
Time frame: 24 hours after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESP Block | Patient Sedation Score at 24 Hours | Sleep | 2 Participants |
| ESP Block | Patient Sedation Score at 24 Hours | Awake | 34 Participants |
| TAP Block | Patient Sedation Score at 24 Hours | Sleep | 1 Participants |
| TAP Block | Patient Sedation Score at 24 Hours | Awake | 38 Participants |
Secondary
Patient Sedation Score at 48 Hours
Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep)
Time frame: 48 hours after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESP Block | Patient Sedation Score at 48 Hours | Awake | 35 Participants |
| ESP Block | Patient Sedation Score at 48 Hours | Sleep | 0 Participants |
| TAP Block | Patient Sedation Score at 48 Hours | Awake | 38 Participants |
| TAP Block | Patient Sedation Score at 48 Hours | Sleep | 1 Participants |