Clinical trial NCT04839445: ESP vs TAP in Total Laparoscopic Hysterectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Gynecologic Cancer
Keywords: Transversus Abdominal Plane Block
Erector Spinae Plane Block
General Anesthesia
Laparoscopic Hysterectomy
Lead sponsor: AUSL Romagna Rimini
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain control
timeFrame: 12 hours
Secondary outcomes:
measure: Intra operative use of opioids.
timeFrame: Surgery time.
measure: Post operative use of non-steroidal anti-inflammatory drugs
timeFrame: 2-6-12-24-36 postoperative hours
measure: Post operative use of opioids
timeFrame: 2-6-12-24-36 postoperative hours
measure: Postoperative nausea and / or vomiting
timeFrame: 2-6-12-24-36 postoperative hours
measure: Days of hospital stay
timeFrame: 3 days
measure: Assessment of patient satisfaction with the anesthesiological technique
timeFrame: 36 hours
Other outcomes:
Locations:
city: Cesena
country: Italy
facility: AUSL Romagna M. Bufalini Hospital
state: Emilia Romagna
Study officials:
affiliation: AUSL Romagna
name: Chiara Rosato, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.