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NCT Number: NCT04839445

ESP vs TAP in Total Laparoscopic Hysterectomy

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.

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AUSL Romagna M. Bufalini Hospital

Cesena, Emilia-Romagna, 47521, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General anesthesia + TAP block

Procedure

Post induction TAP block for intra and postoperative analgesia.

General anesthesia + ESP block

Procedure

Pre induction ESP block for intra and postoperative analgesia.

Primary outcomes

  1. Postoperative pain control

    Time frame: 12 hours

    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.

Secondary outcomes

  1. Intra operative use of opioids.

    Time frame: Surgery time.

    Mcg of Remifentanil consumed during surgery.

  2. Post operative use of non-steroidal anti-inflammatory drugs

    Time frame: 2-6-12-24-36 postoperative hours

    Mg of ketorolac or any others anti-inflammatory drugs administered after surgery.

  3. Post operative use of opioids

    Time frame: 2-6-12-24-36 postoperative hours

    Mg of opioids administered after surgery.

  4. Postoperative nausea and / or vomiting

    Time frame: 2-6-12-24-36 postoperative hours

    Quantity of antiemetic drugs required to control nausea and vomiting episodes

  5. Days of hospital stay

    Time frame: 3 days

    The number of days of hospitalization after surgery will be assessed

  6. Assessment of patient satisfaction with the anesthesiological technique

    Time frame: 36 hours

    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

Sponsors and collaborators

Lead sponsor

AUSL Romagna Rimini

Other

Registry information

Official study 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

Acronym: ARTEMIDE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2021
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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