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ESP vs TAP in Total Laparoscopic Hysterectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04839445
Acronym
ARTEMIDE
Enrollment
78
Registered
2021-04-09
Start date
2021-02-22
Completion date
2022-08-31
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Gynecologic Cancer

Keywords

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

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.

Interventions

PROCEDUREGeneral anesthesia + TAP block

Post induction TAP block for intra and postoperative analgesia.

PROCEDUREGeneral anesthesia + ESP block

Pre induction ESP block for intra and postoperative analgesia.

Sponsors

AUSL Romagna Rimini
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain control12 hoursEvaluate 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.

Secondary

MeasureTime frameDescription
Post operative use of non-steroidal anti-inflammatory drugs2-6-12-24-36 postoperative hoursMg of ketorolac or any others anti-inflammatory drugs administered after surgery.
Post operative use of opioids2-6-12-24-36 postoperative hoursMg of opioids administered after surgery.
Intra operative use of opioids.Surgery time.Mcg of Remifentanil consumed during surgery.
Days of hospital stay3 daysThe number of days of hospitalization after surgery will be assessed
Assessment of patient satisfaction with the anesthesiological technique36 hoursPatients 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 satisfiedexpressed by the patient according to the following scale: satisfied, very satisfied, not at all satisfied
Postoperative nausea and / or vomiting2-6-12-24-36 postoperative hoursQuantity of antiemetic drugs required to control nausea and vomiting episodes

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026