Clinical trial NCT04587973: Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies
Official title: The Effectiveness of Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies. A Randomized, Controlled, Double Blind, Prospective, Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Pain Syndrome
Pain, Acute
Anesthesia
Cholecystectomy
Erector Spinae Plane Block
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain score 3 hours postoperatively
timeFrame: 3 hours after surgery
measure: pain score 6 hours postoperatively
timeFrame: 6 hours after surgery
measure: pain score 12 hours postoperatively
timeFrame: 12 hours after surgery
measure: pain score 24 hours postoperatively
timeFrame: 24 hours after surgery
measure: pain score on arrival to Post-Anesthesia Care Unit (PACU)
timeFrame: immediately postoperatively
measure: 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"
timeFrame: immediately postoperatively
Secondary outcomes:
measure: morphine consumption
timeFrame: 24 hours postoperatively
measure: satisfaction from postoperative analgesia
timeFrame: 24 hours postoperatively
measure: mobilization time
timeFrame: 24 hours postoperatively
measure: hospitalization time
timeFrame: 72 hours postoperatively
measure: intraoperative dose of remifentanil infusion (μg kg-1)
timeFrame: intraoperatively
measure: Erector Spinae Plane Block-related complications
timeFrame: 48 hours postoperatively
measure: Post Anesthesia Care Unit (PACU) duration of stay
timeFrame: immediately postoperatively
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: George Papanikolaou, General Hospital of Thessaloniki
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD, DESA
role: STUDY_CHAIR
References:
citation: Ibrahim M. Erector Spinae Plane Block in Laparoscopic Cholecystectomy, Is There a Difference? A Randomized Controlled Trial. Anesth Essays Res. 2020 Jan-Mar;14(1):119-126. doi: 10.4103/aer.AER_144_19. Epub 2020 Feb 3.
citation: Herman JA, Urits I, Kaye AD, Urman RD, Viswanath O. Erector Spinae Plane Block (ESPB) or Quadratus Lumborum Block (QLB-II) for laparoscopic cholecystectomy: Impact on postoperative analgesia. J Clin Anesth. 2020 Nov;66:109958. doi: 10.1016/j.jclinane.2020.109958. Epub 2020 Jun 17. No abstract available.
citation: Kwon HM, Kim DH, Jeong SM, Choi KT, Park S, Kwon HJ, Lee JH. Does Erector Spinae Plane Block Have a Visceral Analgesic Effect?: A Randomized Controlled Trial. Sci Rep. 2020 May 21;10(1):8389. doi: 10.1038/s41598-020-65172-0.
citation: Peker K, Akcaboy ZN, Aydin G, Gencay I, Sahin AT, Kocak YF, Peker SA. The Effect of Erector Spinae Plane Block on Laparoscopic Cholecystectomy Anesthesia: Analysis of Opioid Consumption, Sevoflurane Consumption, and Cost. J Laparoendosc Adv Surg Tech A. 2020 Jul;30(7):725-729. doi: 10.1089/lap.2019.0809. Epub 2020 Feb 5.
citation: Aygun H, Kavrut Ozturk N, Pamukcu AS, Inal A, Kiziloglu I, Thomas DT, Tulgar S, Nart A. Comparison of ultrasound guided Erector Spinae Plane Block and quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy patients; a prospective randomized study. J Clin Anesth. 2020 Jun;62:109696. doi: 10.1016/j.jclinane.2019.109696. Epub 2019 Dec 18.
citation: Raft J, Chin KJ, Gobert Q, Richebe P, Brulotte V. Defining the optimal analgesic strategy for erector spinae plane (ESP) blocks in unanticipated open cholecystectomy. Korean J Anesthesiol. 2019 Oct;72(5):504-505. doi: 10.4097/kja.d.18.00350. Epub 2018 Dec 28. No abstract available.
citation: Sifaki F, Mantzoros I, Koraki E, Bagntasarian S, Christidis P, Theodoraki K. The Effect of Ultrasound-guided Bilateral Erector Spinae Plane Block With and Without Dexmedetomidine on Intraoperative and Postoperative Pain in Laparoscopic Cholecystectomies: A Randomized, Controlled, Double-blind, Prospective Trial. Pain Physician. 2022 Oct;25(7):E999-E1008.