ESP Block VS TAP in Laparoscopic Hysterectomy

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

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).

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: bupivacaine, 0.125%

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital
    • Indianapolis, Indiana, United States, 46202
      • Indiana Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Drug: Liposomal bupivacaine; 20ml; Other Names: Exparel; Drug: bupivacaine, 0.125%; 60ml; Other Names: bupivacaine
Active Comparator: 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).	Drug: Liposomal bupivacaine; 20ml; Other Names: Exparel; Drug: bupivacaine, 0.125%; 60ml; Other Names: bupivacaine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Matthew Warner, MD, Indiana University Hospital

Publications and helpful links

General Publications

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
• Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
• Shaffer EE, Pham A, Woldman RL, Spiegelman A, Strassels SA, Wan GJ, Zimmerman T. Estimating the Effect of Intravenous Acetaminophen for Postoperative Pain Management on Length of Stay and Inpatient Hospital Costs. Adv Ther. 2017 Jan;33(12):2211-2228. doi: 10.1007/s12325-016-0438-y. Epub 2016 Nov 9.
• Routman HD, Israel LR, Moor MA, Boltuch AD. Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Apr;26(4):641-647. doi: 10.1016/j.jse.2016.09.033. Epub 2016 Nov 15.
• Bacal V, Rana U, McIsaac DI, Chen I. Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):40-52. doi: 10.1016/j.jmig.2018.04.020. Epub 2018 Apr 30.
• Petsas D, Pogiatzi V, Galatidis T, Drogouti M, Sofianou I, Michail A, Chatzis I, Donas G. Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a case report. J Pain Res. 2018 Sep 24;11:1983-1990. doi: 10.2147/JPR.S164489. eCollection 2018.
• Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547.
• Hadzic A, Minkowitz HS, Melson TI, Berkowitz R, Uskova A, Ringold F, Lookabaugh J, Ilfeld BM. Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty. Anesthesiology. 2016 Jun;124(6):1372-83. doi: 10.1097/ALN.0000000000001117.
• Wu ZQ, Min JK, Wang D, Yuan YJ, Li H. Liposome bupivacaine for pain control after total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2016 Jul 22;11(1):84. doi: 10.1186/s13018-016-0420-z.
• Warner M, Yeap YL, Rigueiro G, Zhang P, Kasper K. Erector spinae plane block versus transversus abdominis plane block in laparoscopic hysterectomy. Pain Manag. 2022 Nov;12(8):907-916. doi: 10.2217/pmt-2022-0037. Epub 2022 Oct 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): March 4, 2021
• Study Completion (Actual): March 4, 2021

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 1903977303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No