Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies
- Conditions
- Pain, PostoperativeAnesthesiaErector Spinae Plane BlockPain SyndromePain, AcuteCholecystectomy
- Interventions
- Procedure: Group DexmedetomidineProcedure: Group RopivacaineProcedure: Group Control
- Registration Number
- NCT04587973
- Lead Sponsor
- Aretaieion University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- ASA I, II
- Laparoscopic cholecystectomy
- Elective surgery
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group Dexmedetomidine Group Dexmedetomidine Ropivacaine plus dexmedetomidine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml) plus dexmedetomidine 1 mcg/kg Group Ropivacaine Group Ropivacaine Plain ropivacaine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml) Group Control Group Control Control group - Preoperative bilateral erector spinae plane block with N/S 0,9% (40 ml)
- Primary Outcome Measures
Name Time Method 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" immediately postoperatively pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU
pain score 6 hours postoperatively 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"
pain score 12 hours postoperatively 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"
pain score on arrival to Post-Anesthesia Care Unit (PACU) 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"
pain score 3 hours postoperatively 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"
pain score 24 hours postoperatively 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"
- Secondary Outcome Measures
Name Time Method mobilization time 24 hours postoperatively time at which the patient mobilizes after surgery
hospitalization time 72 hours postoperatively duration of hospital stay after surgery in days
Erector Spinae Plane Block-related complications 48 hours postoperatively block-related complications at the site of the local anesthetic injection
satisfaction from postoperative analgesia 24 hours postoperatively satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
morphine consumption 24 hours postoperatively morphine consumption through patient-controlled analgesia device for 24 hours postoperatively
intraoperative dose of remifentanil infusion (μg kg-1) intraoperatively dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure within the 20% of baseline value
Post Anesthesia Care Unit (PACU) duration of stay immediately postoperatively duration of patient stay at PACU
Trial Locations
- Locations (1)
George Papanikolaou, General Hospital of Thessaloniki
🇬🇷Thessaloníki, Greece