AUSL Romagna M. Bufalini Hospital
Cesena, Emilia-Romagna, 47521, Italy
NCT Number: NCT04839445
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.
Looking for future studies?
Notify Me18 year–85 year
Female
Interventional
Not applicable
Cesena, Emilia-Romagna, 47521, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Post induction TAP block for intra and postoperative analgesia.
Pre induction ESP block for intra and postoperative analgesia.
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.
Time frame: Surgery time.
Mcg of Remifentanil consumed during surgery.
Time frame: 2-6-12-24-36 postoperative hours
Mg of ketorolac or any others anti-inflammatory drugs administered after surgery.
Time frame: 2-6-12-24-36 postoperative hours
Mg of opioids administered after surgery.
Time frame: 2-6-12-24-36 postoperative hours
Quantity of antiemetic drugs required to control nausea and vomiting episodes
Time frame: 3 days
The number of days of hospitalization after surgery will be assessed
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
AUSL Romagna Rimini
Other
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
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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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