Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-04-01

Brief Summary

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The aim of the trial is to study the efficacy of bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic cholecystectomy

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Detailed Description

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Laparoscopic cholecystectomy is one of the most common performed procedures of general surgery. Although it is performed with minimally invasive techniques, postoperative pain can be moderate to severe, requiring administration of large doses of opioids perioperatively in combination with other categories of analgesics in order to be relieved. Modern anesthesiology practices tend to limit the opioids administered to patients due to a variety of complications observed, specifically in certain populations (obese, elderly) and also due to the opioid crisis appearance in United States and in many European countries. As such, multimodal analgesia and opioid limitation is the cornerstone of modern perioperative pain management.

Peripheral nerve blocks and especially trunk blocks can play a significant role when confronting perioperative pain. Erector spinae Plane Block (ESPB) is a novel trunk block first described in order to relieve thoracic neuropathic pain. Since then, it was performed by anesthesiologists for chronic pain, acute post traumatic pain and in a wide variety of surgical procedures for postoperative analgesia.

There are no trials that study the efficacy of adding dexmedetomidine as an adjuvant to the local anesthetic in order to ameliorate the quality and extend the duration of the Erector Spinae Plane Block.

This trial is a randomized, controlled, double - blind, prospective trial, aiming at assessing the efficacy of bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic cholecystectomy. In this trial, 60 patients (men and women), aged 18 to 70 years old that will undergo laparoscopic cholecystectomy which will be performed by the same experienced, surgical team, will be recruited.

Patients will be randomized into three groups, Group D (Ropivacaine plus dexmedetomidine group), Group R (Plain Ropivacaine group) and Group C (Control group).

The solutions that will be administered during the performance of ESPB, will be prepared by an independent anesthesiologist. The ultrasound image during the performance of ESPB, as well as the complications that may arise after the performance of the block, will be recorded.

The age, sex, American Society of Anesthesiologists (ASA) classification, height and weight of the participants, will be recorded.

After the induction of general anesthesia \[propofol (2-3 mg/kg), fentanyl (2-3 γ/kg), rocuronium (0,6 mg/kg)\], general anesthesia will be maintained with desflurane titration. In all patients, remifentanil infusion will be titrated in order to achieve intraoperative analgesia (Systolic Arterial Blood Pressure within the 20% of Baseline Systolic Blood Pressure). In all patients Paracetamol 1000 mg and Tramadol 100 mg will be administered, 30 minutes before the end of surgery. During surgery, vital signs, remifentanil infusion or other drugs that will be administered, will be recorded. At the end of surgery, Train of Four stimulation will be performed and in the presence of remaining neuromuscular blockade, sugammadex will be administered in the proper doses.

In all patients, post - operative analgesia will be offered with a Patient controlled Analgesia (PCA) pump, containing morphine. Lock - out period will be 10 minutes and the morphine dose will be 20 mcg/kg, without continuous infusion.

The duration of stay of the patient in Post Anesthesia Care Unit (PACU), will be recorded as well as the Aldrete Score and the vital signs the moment the patient leaves the PACU.

Postoperative pain will be recorded at arrival and discharge of the patient from the PACU, as well as 3, 6, 12 and 24 hours after the end of surgery, according to NRS pain scale. All patients will receive Paracetamol 1000 mg x 3 (iv) at the surgical ward.

Post - operative nausea and vomiting, morphine consumption and the vital signs of the patients will be recorded 3, 6, 12and 24 hours after surgery. The mobilization time, hospitalization time, as well as the satisfaction score of the patient in a scale from 1 to 6, 24 hours after the end of surgery will be recorded.

Conditions

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Pain, Postoperative Pain Syndrome Pain, Acute Anesthesia Cholecystectomy Erector Spinae Plane Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group Dexmedetomidine

Ropivacaine plus dexmedetomidine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml) plus dexmedetomidine 1 mcg/kg

Group Type ACTIVE_COMPARATOR

Group Dexmedetomidine

Intervention Type PROCEDURE

Ropivacaine plus dexmedetomidine group

Group Ropivacaine

Plain ropivacaine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml)

Group Type ACTIVE_COMPARATOR

Group Ropivacaine

Intervention Type PROCEDURE

Plain ropivacaine group

Group Control

Control group - Preoperative bilateral erector spinae plane block with N/S 0,9% (40 ml)

Group Type PLACEBO_COMPARATOR

Group Control

Intervention Type PROCEDURE

Control group

Interventions

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Group Dexmedetomidine

Ropivacaine plus dexmedetomidine group

Intervention Type PROCEDURE

Group Ropivacaine

Plain ropivacaine group

Intervention Type PROCEDURE

Group Control

Control group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I, II
* Laparoscopic cholecystectomy
* Elective surgery

Exclusion Criteria

* Patient refusal
* Coagulation disorders
* Known allergies to local anesthetics
* Other contraindications to regional anesthesia
* Infection or anatomic anomalies on injection site
* Uncontrolled hypertension
* Severe liver or kidney disease
* Pregnancy
* Known depression or psychiatric disorders, dementia
* Drug or alcohol abuse
* Inadequate command of Greek language

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No