Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238830
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-17
Brief Title:
Evaluation of Multimodal Analgesia With NOL
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Evaluation of Multimodal Analgesia With NOL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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:
None
Brief Summary:
The study will include 80 patients undergoing Laparoscopic Cholecystectomy Surgery as part of elective requirements The study is a single-center prospective randomized controlled trial
The aim of the study is
1 To investigate the effectiveness of multimodal analgesia which includes the newly introduced external oblique intercostal plane block with the assistance of NOL Nociception Level in the management of postoperative pain following commonly performed Laparoscopic Cholecystectomy surgeries
2 This approach is intended to objectively assess changes in postoperative recovery scores
Patients will be divided into two groups the Multimodal Analgesia group Group M where Erector Obliq Interfascial Plane EOIP block NSAID and magnesium infusion will be administered and the control group Group K
The aim of the study is
1 To investigate the effectiveness of multimodal analgesia which includes the newly introduced external oblique intercostal plane block with the assistance of NOL Nociception Level in the management of postoperative pain following commonly performed Laparoscopic Cholecystectomy surgeries
2 This approach is intended to objectively assess changes in postoperative recovery scores
Patients will be divided into two groups the Multimodal Analgesia group Group M where Erector Obliq Interfascial Plane EOIP block NSAID and magnesium infusion will be administered and the control group Group K
Detailed Description:
In the elective laparoscopic cholecystectomy procedures to be performed in the general surgery operating room for 80 patients 80 envelopes containing written papers indicating the Multimodal Analgesia group Group M and the control group Group K will be prepared On the morning of the operation an envelope will be randomly drawn by operating room personnel in a blinded manner to determine the patients inclusion group The patients will be randomized into two groups the Multimodal Analgesia group Group M receiving Erector Oliq Interfascial Plane EOIP block NSAID and magnesium infusion and the control group Group K
Patients will be informed about the procedures to be performed before the surgery and written consent will be obtained After patients are taken to the operating table standard ASA monitoring electrocardiogram non-invasive blood pressure O2 saturation body temperature along with NOL Nociception Level and BIS Bispectral Index monitoring will be applied A peripheral venous line will be established on the dorsum of the hand for normal saline infusion All blocks will be performed under ultrasound guidance
In Group M after routine anesthesia induction intravenous magnesium loading of 30 mgkg will be followed by an infusion of 10 mgkghour Subsequently in the supine position after the necessary field preparation and ultrasound USG setup a linear ultrasound probe will be positioned sagittally between the mid-clavicular and anterior axillary lines at the level of the 6th rib with the orientation marker pointing cranially Identification of the 6th rib can be achieved in two ways either by placing the ultrasound probe at the level of the lower costal margin where the 10th rib is located and then counting upwards or by identifying the 7th rib at the level of the xiphoid process and then moving the ultrasound probe one rib upward
The ultrasound probe will then be rotated to obtain a paramedian sagittal oblique view with the cranial end slightly medial and the caudal end lateral approximately 1 to 2 cm medial to the anterior axillary line Sequentially from superficial to deep the following structures will be identified skin subcutaneous tissue external oblique muscle intercostal muscles between the ribs pleura and lung
For the injection the skin entry point will be at the medial edge of the anterior axillary line just cranial to the 6th rib level using a peripherally directed block needle Echoplex VygonTM France advanced in a superomedial to inferolateral plane along the external oblique muscle The tip of the peripherally directed block needle will be adjusted to the tissue plane between the external oblique and intercostal muscles at the caudal end of the 6th rib and 6th-7th intercostal space A sterile preparation of 20 mL 025 Bupivacaine will be injected into the tissue plane between the 6th and 7th ribs using the hydrodissection technique and then the peripherally directed block needle will be directed caudally towards the eighth rib
Using the in-plane method parallel to the ultrasound probe a negative aspiration will be performed and a total of 20 mL 025 bupivacaine will be injected The distribution of local anesthetic LA will be monitored with ultrasound during the injection The procedure will be applied unilaterally Post-desufflation patients will receive 50 mg dexketoprofen intravenously as standard analgesia
In Group K 50 mg dexketoprofen intravenous NSAID will be administered as standard analgesia serving as the control group
Patients will be informed about the procedures to be performed before the surgery and written consent will be obtained After patients are taken to the operating table standard ASA monitoring electrocardiogram non-invasive blood pressure O2 saturation body temperature along with NOL Nociception Level and BIS Bispectral Index monitoring will be applied A peripheral venous line will be established on the dorsum of the hand for normal saline infusion All blocks will be performed under ultrasound guidance
In Group M after routine anesthesia induction intravenous magnesium loading of 30 mgkg will be followed by an infusion of 10 mgkghour Subsequently in the supine position after the necessary field preparation and ultrasound USG setup a linear ultrasound probe will be positioned sagittally between the mid-clavicular and anterior axillary lines at the level of the 6th rib with the orientation marker pointing cranially Identification of the 6th rib can be achieved in two ways either by placing the ultrasound probe at the level of the lower costal margin where the 10th rib is located and then counting upwards or by identifying the 7th rib at the level of the xiphoid process and then moving the ultrasound probe one rib upward
The ultrasound probe will then be rotated to obtain a paramedian sagittal oblique view with the cranial end slightly medial and the caudal end lateral approximately 1 to 2 cm medial to the anterior axillary line Sequentially from superficial to deep the following structures will be identified skin subcutaneous tissue external oblique muscle intercostal muscles between the ribs pleura and lung
For the injection the skin entry point will be at the medial edge of the anterior axillary line just cranial to the 6th rib level using a peripherally directed block needle Echoplex VygonTM France advanced in a superomedial to inferolateral plane along the external oblique muscle The tip of the peripherally directed block needle will be adjusted to the tissue plane between the external oblique and intercostal muscles at the caudal end of the 6th rib and 6th-7th intercostal space A sterile preparation of 20 mL 025 Bupivacaine will be injected into the tissue plane between the 6th and 7th ribs using the hydrodissection technique and then the peripherally directed block needle will be directed caudally towards the eighth rib
Using the in-plane method parallel to the ultrasound probe a negative aspiration will be performed and a total of 20 mL 025 bupivacaine will be injected The distribution of local anesthetic LA will be monitored with ultrasound during the injection The procedure will be applied unilaterally Post-desufflation patients will receive 50 mg dexketoprofen intravenously as standard analgesia
In Group K 50 mg dexketoprofen intravenous NSAID will be administered as standard analgesia serving as the control group
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?:
None
Is an FDA AA801 Violation?:
None