ESP Block VS TAP in Laparoscopic Hysterectomy

Phase 3

Completed

• Conditions: Hysterectomy
• Interventions: Drug: Liposomal bupivacaine; Drug: bupivacaine, 0.125%

• Registration Number: NCT04003987
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-07-01
• Primary Completion: 2021-03-04
• Study Completion: 2021-03-04
• Results First Submitted: 2022-03-28
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-08
• Results First Posted: 2022-07-05
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP Block	bupivacaine, 0.125%	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)
TAP Block	Liposomal bupivacaine	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).
TAP Block	bupivacaine, 0.125%	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).
ESP Block	Liposomal bupivacaine	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)

Primary Outcome Measures

Name	Time	Method
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)
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)

Secondary Outcome Measures

Name	Time	Method
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 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)
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 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)

Trial Locations

Locations (2)

Indiana Univeristy; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States