Clinical trial NCT04003987: ESP Block VS TAP in Laparoscopic Hysterectomy
Official title: Erector Spinae Plane Block Versus Transverse Abdominis Plane Block in Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hysterectomy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. ESP Block Group
2. TAP Block Group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour.
timeFrame: 1 hour after surgery
measure: Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours.
timeFrame: 24 hours after surgery
measure: Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours.
timeFrame: 48 hours after surgery
measure: Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour.
timeFrame: 1 hour after surgery
measure: Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours.
timeFrame: 24 hours after surgery
measure: Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours.
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Patient Sedation Score at 1 Hour
timeFrame: 1 hour after surgery
measure: Patient Sedation Score at 24 Hours
timeFrame: 24 hours after surgery
measure: Patient Sedation Score at 48 Hours
timeFrame: 48 hours after surgery
measure: Patient Nausea Score at 1 Hour
timeFrame: 1 hour after surgery
measure: Patient Nausea Score at 24 Hour
timeFrame: 24 hour after surgery
measure: Patient Nausea Score at 48 Hour
timeFrame: 48 hour after surgery
measure: Patient Satisfaction Score at 24 Hours
timeFrame: 24 hours after surgery
measure: Patient Satisfaction Score at 48 Hours
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Univeristy
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University Hospital
name: Yar Yeap, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University Hospital
name: Matthew Warner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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citation: 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.