ESP vs TAP in Total Laparoscopic Hysterectomy

NCT04839445 | Completed

• 1 other identifier: 2909
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Gynecologic Cancer

Keywords

Transversus Abdominal Plane Block; Erector Spinae Plane Block; General Anesthesia; Laparoscopic Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Intra operative use of opioids.

  Surgery time.

• Post operative use of non-steroidal anti-inflammatory drugs

  2-6-12-24-36 postoperative hours

• Post operative use of opioids

  2-6-12-24-36 postoperative hours

• Postoperative nausea and / or vomiting

  2-6-12-24-36 postoperative hours

• Days of hospital stay

  3 days

Study Arms (2)

General anesthesia + TAP block

ACTIVE COMPARATOR

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

General anesthesia + ESP block

ACTIVE COMPARATOR

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

Interventions

General anesthesia + TAP block PROCEDURE

Post induction TAP block for intra and postoperative analgesia.

General anesthesia + TAP block

General anesthesia + ESP block PROCEDURE

Pre induction ESP block for intra and postoperative analgesia.

General anesthesia + ESP block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AUSL Romagna Rimini: lead

Study Sites (1)

AUSL Romagna M. Bufalini Hospital

Cesena, Emilia-Romagna, 47521, Italy

Location

Related Publications (2)

• 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.

  PMID: 33122942 RESULT

• 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.

  PMID: 32490608 RESULT

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Chiara Rosato, MD

  AUSL Romagna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 9, 2021
• Study Start: February 22, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)