ESP vs TAP in Total Laparoscopic Hysterectomy

Anesthesia Clinical Trial

— ARTEMIDE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839445
• Other study ID #: 2909
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2022
• Source: AUSL Romagna Rimini
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Gynecologic Cancer

Intervention

Procedure:
• General anesthesia + TAP block
Post induction TAP block for intra and postoperative analgesia.
• General anesthesia + ESP block
Pre induction ESP block for intra and postoperative analgesia.

Locations

Country	Name	City	State
Italy	AUSL Romagna M. Bufalini Hospital	Cesena	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
AUSL Romagna Rimini

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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/S0375-9 — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intra operative use of opioids.	Mcg of Remifentanil consumed during surgery.	Surgery time.
Secondary	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
Secondary	Post operative use of opioids	Mg of opioids administered after surgery.	2-6-12-24-36 postoperative hours
Secondary	Postoperative nausea and / or vomiting	Quantity of antiemetic drugs required to control nausea and vomiting episodes	2-6-12-24-36 postoperative hours
Secondary	Days of hospital stay	The number of days of hospitalization after surgery will be assessed	3 days
Secondary	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