EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial

Sponsor

Democritus University of Thrace (Other)

Overall Status

Recruiting

CT.gov ID

NCT04879004

Collaborator

Aristotle University Of Thessaloniki (Other)

Enrollment

Location

Arms

16.9

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Acute Pain Postoperative Complications Pain Ropivacaine Analgesia Regional Anesthesia Analgesics Anesthesia, Local Colorectal Cancer Perioperative Pain	Drug: Ropivacaine injection	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ropivacaine Group ESPB performed with infusion of Ropivacaine 0,375% (20 ml at ech side)	Drug: Ropivacaine injection Effect of continuous ESPB performed with Ropivacaine 0,375% infusion, in patients undergoing elective laparoscopic colectomy.
Placebo Comparator: Control Group ESPB performed with infusion of N/S 0,9% (20 ml at each side)	Drug: Ropivacaine injection Effect of continuous ESPB performed with Ropivacaine 0,375% infusion, in patients undergoing elective laparoscopic colectomy.

Arm

Intervention/Treatment

Experimental: Ropivacaine Group

ESPB performed with infusion of Ropivacaine 0,375% (20 ml at ech side)

Drug: Ropivacaine injection

Effect of continuous ESPB performed with Ropivacaine 0,375% infusion, in patients undergoing elective laparoscopic colectomy.

Placebo Comparator: Control Group

ESPB performed with infusion of N/S 0,9% (20 ml at each side)

Drug: Ropivacaine injection

Effect of continuous ESPB performed with Ropivacaine 0,375% infusion, in patients undergoing elective laparoscopic colectomy.

Outcome Measures

Primary Outcome Measures

Total Perioperative Tramadol Consumption [96 hours after surgery]
Total Perioperative Tramadol Consumption
Quality of Recovery [72 hours Post - Operatively]
Quality of Recovery-15 [(QoR) -15] Questionnaire. A questionnaire which consists of 15 questions in two Parts, rated from 0 to 10 ("0" is the worst and "10" is the best answer). The worst overall score is 0 and the best overall score is 150.
Mobilization Time [In a time frame of up to 72 hours Post - Operatively]
Time of Mobilization of the gastrointestinal tract and of the patient
Start of Oral Fluids and Nutrition [In a time frame up to 72 hours Post - Operatively]
Time of start of oral fluids and enteral nutrition
Satisfaction from Perioperative Analgesia [96 hours post - operatively]
Satisfaction Score of the patient regarding perioperative analgesia, using a numerical rating scale from 1 to 6, where "1" means not satisfied at all and "6" means completely satisfied.
Hospitalization Days [In a time frame up to 2 Weeks Post - Operatively]
Duration of hospital stay after surgery in days

Secondary Outcome Measures

Pain Score, Post Operative Nausea and Vomiting Score at discharge from Post-Anesthesia Care Unit (PACU) [Immediately Post - Operatively]
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", Post Operative Nausea and Vomiting Score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.
Pain Score, Post Operative Nausea and Vomiting Score 12 hours post-operatively [12 hours post - operatively]
Pain score 12 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 12 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.
Pain Score, Post Operative Nausea and Vomiting Score 24 hours post-operatively [24 hours post - operatively]
Pain score 24 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 24 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.
Pain Score, Post Operative Nausea and Vomiting Score 36 hours post-operatively [36 hours post - operatively]
Pain score 36 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 36 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.
Pain Score, Post Operative Nausea and Vomiting Score 48 hours post-operatively [48 hours post - operatively]
Pain score 48 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 48 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.
Total Desflurane Consumption [Intra - Operatively]
Total intraoperative Desflurane Consumption
Total Remifentanyl Consumption [Intra - Operatively]
Total intraoperative Remifentanyl Consumption
Post Anesthesia Care Unit (PACU) Duration of stay [Immediately post-operatively]
Duration of patient stay at PACU
Total Cost [Perioperatively]
Total cost of surgery, anesthesia and hospitalization
TNF-a, IL-1, IL-6 levels post-operatively [Pre-operatively and the 1st and 4th day post-operatively]
Comparison of TNF-a, Interleukine-1 and Interleukine-6 levels preoperatively and post - operatively (the first and fourth day after surgery)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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