ESP Block VS TAP in Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Erector Spinae Plane Block Versus Transverse Abdominis Plane Block in Laparoscopic Hysterectomy

Conditions
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Hysterectomy

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: bupivacaine, 0.125%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: ESP Block Group TAP Block Group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESP Block<br>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) | Drug: Liposomal bupivacaine<br>* 20ml<br>* Other names: Exparel;Drug: bupivacaine, 0.125%<br>* 60ml<br>* Other names: bupivacaine;|
| Active Comparator: TAP Block<br>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). | Drug: Liposomal bupivacaine<br>* 20ml<br>* Other names: Exparel;Drug: bupivacaine, 0.125%<br>* 60ml<br>* Other names: bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1 hour after surgery | 
| 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) | 24 hours after surgery | 
| 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) | 48 hours after surgery | 
| 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) | 1 hour after surgery | 
| 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) | 24 hours after surgery | 
| 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) | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1 hour after surgery | 
| 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) | 24 hours after surgery | 
| 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) | 48 hours after surgery | 
| Patient Nausea Score at 1 Hour | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) | 1 hour after surgery | 
| Patient Nausea Score at 24 Hour | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) | 24 hour after surgery | 
| Patient Nausea Score at 48 Hour | Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe) | 48 hour after surgery | 
| 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) | 24 hours after surgery | 
| 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) | 48 hours after surgery |