Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies

July 10, 2022 updated by: Dr Kassiani Theodoraki, Aretaieion University Hospital

The Effectiveness of Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies. A Randomized, Controlled, Double Blind, Prospective, Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloníki, Greece, 57010
        • George Papanikolaou, General Hospital of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Dexmedetomidine
Ropivacaine plus dexmedetomidine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml) plus dexmedetomidine 1 mcg/kg
Procedure: Group Dexmedetomidine
Ropivacaine plus dexmedetomidine group
Active Comparator: Group Ropivacaine
Plain ropivacaine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml)
Procedure: Group Ropivacaine
Plain ropivacaine group
Placebo Comparator: Group Control
Control group - Preoperative bilateral erector spinae plane block with N/S 0,9% (40 ml)
Procedure: Group Control
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score on arrival to Post-Anesthesia Care Unit (PACU)
Time Frame: immediately postoperatively
pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
immediately postoperatively
pain score 6 hours postoperatively
Time Frame: 6 hours after surgery
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
6 hours after surgery
pain score 12 hours postoperatively
Time Frame: 12 hours after surgery
pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
12 hours after surgery
pain score 24 hours postoperatively
Time Frame: 24 hours after surgery
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
24 hours after surgery
pain score 3 hours postoperatively
Time Frame: 3 hours after surgery
pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
3 hours after surgery
pain score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Time Frame: immediately postoperatively
pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU
immediately postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Anesthesia Care Unit (PACU) duration of stay
Time Frame: immediately postoperatively
duration of patient stay at PACU
immediately postoperatively
satisfaction from postoperative analgesia
Time Frame: 24 hours postoperatively
satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
24 hours postoperatively
morphine consumption
Time Frame: 24 hours postoperatively
morphine consumption through patient-controlled analgesia device for 24 hours postoperatively
24 hours postoperatively
mobilization time
Time Frame: 24 hours postoperatively
time at which the patient mobilizes after surgery
24 hours postoperatively
hospitalization time
Time Frame: 72 hours postoperatively
duration of hospital stay after surgery in days
72 hours postoperatively
intraoperative dose of remifentanil infusion (μg kg-1)
Time Frame: intraoperatively
dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure within the 20% of baseline value
intraoperatively
Erector Spinae Plane Block-related complications
Time Frame: 48 hours postoperatively
block-related complications at the site of the local anesthetic injection
48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aretaieion University Hospital

Investigators

  • Study Chair: Kassiani Theodoraki, PhD, DESA, ARETAIEION University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 10, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPB-Frida

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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