Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04879004
Status:
UNKNOWN
Last Update Posted:
2021-05-10
First Post:
2021-05-01
Brief Title:
EFFECT - EFFectiveness of ESPB Erector Spinae Plane Block in Laparoscopic Cοlectomies Trial
Sponsor:
Democritus University of Thrace
Organization:
Democritus University of Thrace
Study Overview
Official Title:
Effectiveness of Bilateral Erector Spinae Plane Block ESPB in Laparoscopic Colectomies -A Randomized Controlled Double Blind Prospective Trial
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFFECT
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
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 US 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 0375 and Group C Control group - NS 09
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 25 mgkg fentanyl 1 γkg rocuronium 06 mgkg 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 mgkg and Pantoprazole 40 mg will be administered at the start of the surgical procedure Paracetamol 1000 mg Tramadol 100 mg Droperidol 125 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 0375 patients randomized in Group B or NS 09 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
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 0375 and Group C Control group - NS 09
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 25 mgkg fentanyl 1 γkg rocuronium 06 mgkg 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 mgkg and Pantoprazole 40 mg will be administered at the start of the surgical procedure Paracetamol 1000 mg Tramadol 100 mg Droperidol 125 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 0375 patients randomized in Group B or NS 09 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None