Trial Title:
EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial
NCT ID:
NCT04879004
Condition:
Pain, Postoperative
Acute Pain
Postoperative Complications
Pain
Ropivacaine
Analgesia
Regional Anesthesia
Analgesics
Anesthesia, Local
Colorectal Cancer
Perioperative Pain
Conditions: Official terms:
Pain, Postoperative
Postoperative Complications
Acute Pain
Ropivacaine
Conditions: Keywords:
Erector Spinae Plane Block
Regional Anaesthesia
Opioid - Free Anaesthesia
Opioid Sparing Techniques
Laparoscopic Colectomy
Perioperative Pain
General Surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Ropivacaine injection
Description:
Effect of continuous ESPB performed with Ropivacaine 0,375% infusion, in patients
undergoing elective laparoscopic colectomy.
Arm group label:
Control Group
Arm group label:
Ropivacaine Group
Summary:
The aim of the trial is to study the efficacy of continuous bilateral Erector Spinae
Plane Block (ESPB) in managing perioperative pain in patients who undergo elective
laparoscopic colectomy.
Detailed description:
Laparoscopic colectomy is a common surgery performed by general surgeons for a variety of
reasons, such as colon cancer, inflammatory bowel disease, multiple precancerous colon
polyps. Nowadays, due to the evolution of laraposcopic techniques, laparoscopic
colectomies are performed with minimally invasive procedures. However, most patients
complain for moderate to severe post-operative pain, which requires the application of
multimodal analgesia recipes and the administration of large doses of opioids
perioperatively, in order to be relieved. Due to the opioid crisis observed in the U.S.
and in many european countries and due to the variety of adverse effects observed after
the administration of opioids (respiratory depression, nausea, vomiting, delayed
mobilization of gastrointestinal system and the patient), which augment not only the
hospitalization time but also the hospitilization cost of the patients, anesthesiologists
tend to limit their administration, especially in colectomies.
Erector Spinae Plane Block (ESPB) is an innovating trunk block, which was first described
in 2016 by Forrero et. al in order to relieve neuropathic pain. Since then, it was
embraced by modern anesthesia practices and is currently effectively performed for
chronic pain, acute post-traumatic and acute post-operative pain, in various surgical
procedures. Specifically, ESPB has been performed for the treatment of thoracic
neuropathic pain, of acute post-operative pain after thoracotomy, laparoscopic
cholecystectomy, total hip arthroplasty, modified radical mastectomy, emergent laparotomy
and after various surgical procedures of the spine, with good results.
There are no clinical trials that study the effectiveness of continuous bilateral Erector
Spinae Plane Block in laparoscopic colectomies.
This trial is a randomized, controlled, double - blind, prospective trial, predominantly
aiming at evaluating the effectiveness of continuous bilateral Erector Spinae Plane Block
(ESPB) in managing perioperative pain in patients who undergo elective laparoscopic
colectomy.
This trial will recruit 40 patients (men and women), aged 18 to 85 years old who will
undergo laparoscopic colectomy, performed by the same experienced, surgical team.
Patients will be randomized into two groups, Group B (Block Group - Ropivacaine 0,375%)
and Group C (Control group - N/S 0,9%).
ESPB will be performed bilaterally, accompanied with the placement of catheters for
continuous solution infusion, by the same, experienced in regional anesthesia
anesthesiologist, before the induction of general anesthesia. The solutions administered
during the performance of ESPB, will be prepared by an independent anesthesiology nurse.
The quality of the ultrasound image and the pain intensity during the performance of
ESPB, as well as the dermotomes blocked by ESPB and the complications that may arise
after the performance of the block, will be recorded.
The age, sex, Body Mass Index and American Society of Anesthesiologists (ASA)
classification of the participants, will be recorded. Preoperative standard laboratory
tests, as well as TNF-a, Interleukine-1 and Interleukine-6 levels will be recorded.
After the induction of general anesthesia [propofol (2,5 mg/kg), fentanyl (1 γ/kg),
rocuronium (0,6 mg/kg)], general anesthesia will be maintained with desflurane titration,
guided by BIS Monitor readings. In all patients, remifentanil infusion will be titrated
in order to achieve intraoperative analgesia, guided by Nociception Monitoring (NOL
Monitor). In all patients Magnesium Sulphate 50 mg/kg and Pantoprazole 40 mg will be
administered at the start of the surgical procedure. Paracetamol 1000 mg, Tramadol 100
mg, Droperidol 1,25 mg and Ondansetron 4 mg will be also administered to all patients 30
minutes before the end of surgery. During surgery, vital signs, BIS and NOL readings,
Cardiac Output, Stroke Volume Variation, Glucose and Lactate levels will be recorded.
Total fluids, desflurane and remifentanyl administration, urine output, as well as the
administration of other drugs will also 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 include administration of Paracetamol
1000 mg every 6 hours. Tramadol 50 mg will be offered as rescue analgesia, if NRS pain
score of the patient is > 4. 12, 24, 36 and 48 hours after the performance of ESPB,
Ropivacaine 0,375% (patients randomized in Group B) or N/S 0,9% (patients randomized in
Group C) will be infused through the ESPB catheters.
The duration of stay of the patient in Post Anesthesia Care Unit (PACU), the Aldrete
Score and the vital signs the moment the patient leaves the PACU, will be recorded.
Post - operative observation of the patient will include recording of NRS pain score at
rest and activity, Post-Operative Nausea and Vomiting Score, tramadol consumption, vital
signs, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the end of surgery. Quality of
Recovery Score of the patient will be recorded 72 hours after the end of surgery.
Mobilization time of the patient and of the gastrointestinal tract, the time of removal
of bladder catheter and drainages, the time of start of oral fluids and enteral
nutrition, the discharge time and the total cost, will also be recorded. The satisfaction
score of the patient in a scale from 1 to 6, 96 hours after the end of surgery will be
recorded. Standard laboratory tests of the first, second and third post-operative days
will be recorded, as well as the TNF-a, Interleukine-1 and Interleukine-6 levels the
first and the fourth post-operative day.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
ASA I, II, III Laparoscopic colectomy Elective surgery
Exclusion Criteria:
Patient refusal 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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Georgios Papanikolaou, General Hospital of Thessaloniki
Address:
City:
Thessaloníki
Zip:
57010
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Freideriki Sifaki, M.D., MSc
Phone:
00306970721829
Email:
frida1sif1@gmail.com
Investigator:
Last name:
Pelagia Chloropoulou, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Freideriki Sifaki, MSc
Email:
Principal Investigator
Start date:
January 1, 2021
Completion date:
May 31, 2022
Lead sponsor:
Agency:
Democritus University of Thrace
Agency class:
Other
Collaborator:
Agency:
Aristotle University Of Thessaloniki
Agency class:
Other
Source:
Democritus University of Thrace
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04879004
