ESP Block VS TAP in Laparoscopic Hysterectomy

Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003987
• Other study ID #: 1903977303
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2019
• Est. completion date: March 4, 2021

Study information

• Verified date: June 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 4, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Drug:
• Liposomal bupivacaine
20ml
• bupivacaine, 0.125%
60ml

Locations

Country	Name	City	State
United States	Indiana Univeristy	Indianapolis	Indiana
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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.0000 — View Citation

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 — View Citation

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: 10.1 — View Citation

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. Epub — View 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. Review. — View 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: 10.1 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	1 hour after surgery
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)	24 hours after surgery
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)	48 hours after surgery
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)	1 hour after surgery
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)	24 hours after surgery
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)	48 hours after surgery
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)	1 hour after surgery
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)	24 hours after surgery
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)	48 hours after surgery
Secondary	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
Secondary	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
Secondary	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
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)	24 hours after surgery
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)	48 hours after surgery