ESP vs TAP in Total Laparoscopic Hysterectomy (ARTEMIDE)

Comparison of Efficacy of Ultrasound-guided Erector Spinae Place Block Versus Transversus Abdominis Plane Block for Intra and Postoperative Pain Control in Total Laparoscopic Hysterectomy: a Randomized Controlled Trial

The anesthetic techniques for videolaparoscopic surgery include general anesthesia, and locoregional anesthesia in association with general anesthesia in order to reduce or abolish post-operative pain with a simultaneous reduction in the use of opioids and days of hospital stay.

From the studies published so far on videolaparoscopic surgery in general, it is clear that the transversus abdominal plane (TAP) block could have a role in reducing the stretch wall pain secondary to pneumoperitoneum and incisional, although its role in this regard is not yet clear, nor significant statistically results have been produced. The use of erector spinae plane (ESP) block for the management of visceral pain is finding more and more space in the literature, with promising results.

For videolaparoscopic gynecological surgery, the techniques of locoregional anesthesia studied in association with general anesthesia, up to now, include wall blocks, TAP block and ESP block, while neuraxial anesthesia has no indications in this regard.

Although videolaparoscopic hysterectomy is considered less painful than the open-abdomen technique, it requires careful management of post-operative pain. The pain of this surgery is the result of the sum of incisional pain, at the insertion points of the laparoscopic trocars, pain due to pneumoperitoneum usually referred to the shoulder, and visceral pain purely dependent on surgical maneuvers. There is currently no strong evidence to support the use of locoregional anesthesia techniques in videolaparoscopic gynecological surgery. Few studies have been produced about this topic, and they are mostly case series or randomized controlled trials that take into consideration only one technique among those possible. To date, no study compares the various techniques to evaluate the possible superiority of one over the other.

In our hospital anesthesists carry out, in normal clinical practice, all the aforementioned local anesthesia techniques.

The purpose of our work is to evaluate, with a randomized non-sponsored study, the efficacy of the ESP block and the TAP block for intra and post-operative pain control in videolaparoscopic hysterectomy, and to compare the two techniques.

Based on the evidence available in the literature, the two techniques are already part of the current clinical practice of the Anesthesia Unit of our hospital and the choice of one technique over the other is based on anesthetist clinical evaluation to date. The anesthetists involved in the study are adequately trained on both anesthetic procedures.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Anesthesia
• Intervention / Treatment: Procedure: General anesthesia + TAP block; Procedure: General anesthesia + ESP block

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Emilia Romagna
    • Cesena, Emilia Romagna, Italy, 47521
      • AUSL Romagna M. Bufalini Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• American society of anesthesiologists (ASA) I-III risk
• no contraindication to the execution of the peripheral nerve block
• signature of the informed consent
• total videolaparoscopic surgery (no conversion to open-abdomen)

Exclusion Criteria:

• allergies and / or contraindications to the administration of the drugs used in the study
• infections and injuries at the puncture site
• BMI ≥40
• history of opioid abuse or use of opioids in chronic therapy

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: General anesthesia + TAP block; Induction: remifentanil in total intravenous anesthesia (TIVA), Propofol 2 mg/kg/h and Rocuronium 0.6 mg/kg. Transversus abdominis plane (TAP) block: 20 minutes before surgery. Ropivacaine 0.37% 20ml + dexamethasone 2mg per side. Maintenance: TIVA with Propofol, the infusion rate will be adjusted according to the bispectral index system (BIS) values (30 <BIS <50). Patients will receive additional remifentanil by infusion at 0.02 mcg/kg/min per time if blood pressure and heart rate values exceed 20% pre-operative baseline values. Additional rocuronium 0.1 mg/kg based on clinical needs and train of four (TOF) monitoring. Analgesic starter bolus: 30 minutes before the end of the surgery, paracetamol 1 gr ev and ketorolac 30 mg ev. Postoperative pain: paracetamol 1 gr ev every 8 hours for 36 hours; ketorolac 30 mg ev if NRS >4 / morphine 2 mg ev if NRS >4 30 min after ketorolac administration. In case of nausea and vomiting ondansetron 4 mg ev.	Procedure: General anesthesia + TAP block; Post induction TAP block for intra and postoperative analgesia.
Active Comparator: General anesthesia + ESP block; Erector spinae plane (ESP) block: 20 minutes before surgery. T8 level bilaterally, ropivacaine 0.37% 20ml + dexamethasone 2mg per side. Induction: Remifentanil in TIVA, Propofol 2 mg/kg/h and Rocuronium 0.6 mg/kg. Maintenance: TIVA with Propofol, the infusion rate will be adjusted according to the BIS values (30 <BIS <50). Patients will receive additional remifentanil by infusion at 0.02 mcg/kg/min per time if blood pressure and heart rate values exceed 20% pre-operative baseline values. Additional rocuronium 0.1 mg/kg based on clinical needs and TOF monitoring. Analgesic starter bolus: 30 minutes before the end of the surgery, paracetamol 1 gr ev and ketorolac 30 mg ev. Postoperative pain: paracetamol 1 gr ev every 8 hours for 36 hours; ketorolac 30 mg ev if NRS >4 / morphine 2 mg ev if NRS >4 30 min after ketorolac administration. In case of nausea and vomiting ondansetron 4 mg ev.	Procedure: General anesthesia + ESP block; Pre induction ESP block for intra and postoperative analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain control	Evaluate the difference between the two groups regarding post-operative pain using Numeric Rating Scale (NRS) 0= better outcome; 10=worse outcome Score will be measured on the numeric rating scale (NRS), an NRS ≤ 4 will be considered as effective antalgic coverage.	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra operative use of opioids.	Mcg of Remifentanil consumed during surgery.	Surgery time.
Post operative use of non-steroidal anti-inflammatory drugs	Mg of ketorolac or any others anti-inflammatory drugs administered after surgery.	2-6-12-24-36 postoperative hours
Post operative use of opioids	Mg of opioids administered after surgery.	2-6-12-24-36 postoperative hours
Postoperative nausea and / or vomiting	Quantity of antiemetic drugs required to control nausea and vomiting episodes	2-6-12-24-36 postoperative hours
Days of hospital stay	The number of days of hospitalization after surgery will be assessed	3 days
Assessment of patient satisfaction with the anesthesiological technique	Patients is requested to fill out a pre-printed sheet on their judgment of the anesthesiological procedure, in which they can express a value from 0 to 5, where 0 indicates "entirely dissatisfied" and 5 indi- cates "very satisfied"expressed by the patient according to the following scale: satisfied, very satisfied, not at all satisfied	36 hours

Collaborators and Investigators

• Sponsor: AUSL Romagna Rimini
• Investigators: Principal Investigator: Chiara Rosato, MD, Ausl Romagna

Publications and helpful links

General Publications

• Jones JH, Aldwinckle R. Interfascial Plane Blocks and Laparoscopic Abdominal Surgery: A Narrative Review. Local Reg Anesth. 2020 Oct 23;13:159-169. doi: 10.2147/LRA.S272694. eCollection 2020.
• Bagaphou CT, Santonastaso DP, Rispoli M, Piraccini E, Fusco P, Gori F. Bilateral continuous erector spinae plane block: an alternative to epidural catheter for major open abdominal surgery. Minerva Anestesiol. 2020 Sep;86(9):993-994. doi: 10.23736/S0375-9393.20.14557-7. Epub 2020 Jun 2. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: General Anesthesia; Erector Spinae Plane Block; Laparoscopic Hysterectomy; Transversus Abdominal Plane Block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2909 (Other Identifier: Ethics committee der Aerztekammer Hamburg)

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