Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies
Condition: Pain, Postoperative; Pain Syndrome; Pain, Acute; Anesthesia; Cholecystectomy; Erector Spinae Plane Block
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Group Dexmedetomidine; Group Ropivacaine; Group Control
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Ropivacaine plus dexmedetomidine group; Plain ropivacaine group; Control group
Intervention MeSH terms: Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention