ESP vs TAP in Total Laparoscopic Hysterectomy

NCT04839445 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-10-24

No results posted yet for this study

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

Interventions

PROCEDURE

General anesthesia + TAP block

Post induction TAP block for intra and postoperative analgesia.

PROCEDURE

General anesthesia + ESP block

Pre induction ESP block for intra and postoperative analgesia.

Sponsors & Collaborators

  • AUSL Romagna Rimini

    lead OTHER

Principal Investigators

  • Chiara Rosato, MD · AUSL Romagna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04839445 on ClinicalTrials.gov