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The Effect of Local Anesthetic Infiltration or Erector Spina Plan Block on Stress Hormone Response

Primary Purpose

Post Operative Pain, Erector Spinae Plane Block, Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
wound site local anesthesic infiltration
Erector spina plane block
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Cholecystectomy, Laparoscopic, Erector spinae plane block, analgesia, cortisol, prolactin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: who will undergo laparoscopic cholecystectomy ASA (American Society of Anesthesiology) I-II 18-65 age group operated between 08:00-12:00 in the morning Exclusion Criteria: Pregnant, Emergency surgery ASA (American Society of Anesthesiology)III-IV Patients who did not consent to the study, History of local anesthetic allergy, Coagulation disorder, Morbid obesity (body mass index >40 kg/m²), Severe organ failure, Previous neurological deficit, Psychiatric disease, Patients with a history of chronic pain Who were switched to the open procedure due to surgical complications during the operation

Sites / Locations

  • Sisli Hamidiye Etfal Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

wound site local anesthesic infiltration

Erector spinae plane block

Arm Description

at the end of the operation; 0.5% bupivacaine (1mg/kg) was infiltrated into the fascia muscles and preperitoneal space in equal doses to the wound at the 4 trocar entry site

: Erector spina block was applied to the group, after the end of the operation, the patients were placed in the left lateral decubitus position and the spinous process of the 8th thoracic vertebra was marked under sterile conditions. After visualizing the spinous process with ultrasound (EsoateMyLab™30 Gold, 8-18 MHz, Genova, Italy), the linear probe (8-12 MHz) was shifted 3 cm laterally from the midline in the cranial-caudal direction. Trapezius, erector spinae muscles, transverse process and pleura were visualized, and 20ml of 0.25% bupivacaine was injected into the validated interval by directing the peripheral nerve block needle in the cranio-caudal direction

Outcomes

Primary Outcome Measures

Stress hormone response
Blood was taken and recorded in a yellow capped gel biochemistry tube (SSTTM II Advance Tubes) for the measurement of stress hormone glucose(70-100 mg/dl), prolactin(4.79-23.3µg/dL), and cortisol(60.2-184 µg/dL) 1 hour before and 1 hour after the operation.

Secondary Outcome Measures

Visual Analog Pain Scale
visual analog for pain consist of a horizontal line, usually 100 mm in length. the left end of the line signifies no pain which is depicted by a smiling face while the right end signifies the worst possible pain with a frowning face. this visual depiction of pain levels helps the patient to communicate about the intensity of their pain.
Analgesia period
The time from the end of the operation to the first analgesic requirement was determined as the "analgesia period" and this time was recorded.

Full Information

First Posted
January 24, 2023
Last Updated
July 25, 2023
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05717530
Brief Title
The Effect of Local Anesthetic Infiltration or Erector Spina Plan Block on Stress Hormone Response
Official Title
The Effect of Local Anesthetic Infiltration Into Wound Site or Erector Spina Plan Block on Stress Hormone Response and Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Laparoscopic cholecystectomy is one of the most common operations in abdominal surgery. Effective analgesia in the postoperative period; It is of great importance in terms of acceleration of recovery, prevention of atelectasis, reduction of endocrine and metabolic stress response, reduction of thromboembolic complications, protection of cognitive functions, prevention of chronic pain development, and reduction of hospital stay . Intravenous paracetamol, NSAID/cyclooxygenase-2 selective inhibitors, opioids, local anesthetic infiltration in the port area, intraperitoneal local anesthetic insufflation or plan blocks can be used in the treatment of postoperative pain after laparoscopic cholecystectomy. Operation, tissue trauma, anesthesia, drugs given to the patient, type of anesthesia, blood loss, temperature changes and pain cause postoperative stress response
Detailed Description
Laparoscopic cholecystectomy is one of the most common operations in abdominal surgery. Abdominal and shoulder pain are frequently seen in patients in the postoperative period. Laparoscopic surgery is considered the gold standard in abdominal surgery because of its low cost, less postoperative pain, early mobilization, and short hospital stay. Effective analgesia in the postoperative period; It is of great importance in terms of acceleration of recovery, prevention of atelectasis, reduction of endocrine and metabolic stress response, reduction of thromboembolic complications, protection of cognitive functions, prevention of chronic pain development, and reduction of hospital stay . Intravenous paracetamol, NSAID/cyclooxygenase-2 selective inhibitors, opioids, local anesthetic infiltration in the port area, intraperitoneal local anesthetic insufflation or plan blocks can be used in the treatment of postoperative pain after laparoscopic cholecystectomy. In laparoscopic cholecystectomy operations, the results of pain reduction and analgesic consumption in incisional local anesthetics are variable. Operation, tissue trauma, anesthesia, drugs given to the patient, type of anesthesia, blood loss, temperature changes and pain cause postoperative stress response . In various surgeries, regional anesthesia for post-operative purposes, plan blocks, infiltration or insufflation methods were found to suppress the stress response. In this study, the investigator aimed to compare the effects of local anesthetic infiltration at the wound site and erector spine plane block on stress hormone response and postoperative analgesia in patients who will undergo laparoscopic cholecystectomy surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Erector Spinae Plane Block, Inguinal Hernia
Keywords
Cholecystectomy, Laparoscopic, Erector spinae plane block, analgesia, cortisol, prolactin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
wound site local anesthesic infiltration
Arm Type
Active Comparator
Arm Description
at the end of the operation; 0.5% bupivacaine (1mg/kg) was infiltrated into the fascia muscles and preperitoneal space in equal doses to the wound at the 4 trocar entry site
Arm Title
Erector spinae plane block
Arm Type
Active Comparator
Arm Description
: Erector spina block was applied to the group, after the end of the operation, the patients were placed in the left lateral decubitus position and the spinous process of the 8th thoracic vertebra was marked under sterile conditions. After visualizing the spinous process with ultrasound (EsoateMyLab™30 Gold, 8-18 MHz, Genova, Italy), the linear probe (8-12 MHz) was shifted 3 cm laterally from the midline in the cranial-caudal direction. Trapezius, erector spinae muscles, transverse process and pleura were visualized, and 20ml of 0.25% bupivacaine was injected into the validated interval by directing the peripheral nerve block needle in the cranio-caudal direction
Intervention Type
Procedure
Intervention Name(s)
wound site local anesthesic infiltration
Intervention Description
: at the end of the operation; 0.5% bupivacaine (1mg/kg) was infiltrated into the fascia muscles and preperitoneal space in equal doses to the wound at the 4 trocar entry site.
Intervention Type
Procedure
Intervention Name(s)
Erector spina plane block
Intervention Description
Erector spina block was applied to the group, after the end of the operation, the patients were placed in the left lateral decubitus position and the spinous process of the 8th thoracic vertebra was marked under sterile conditions. After visualizing the spinous process with ultrasound (EsoateMyLab™30 Gold, 8-18 MHz, Genova, Italy), the linear probe (8-12 MHz) was shifted 3 cm laterally from the midline in the cranial-caudal direction. Trapezius, erector spinae muscles, transverse process and pleura were visualized, and 20ml of 0.25% bupivacaine was injected into the validated interval by directing the peripheral nerve block needle in the cranio-caudal direction.
Primary Outcome Measure Information:
Title
Stress hormone response
Description
Blood was taken and recorded in a yellow capped gel biochemistry tube (SSTTM II Advance Tubes) for the measurement of stress hormone glucose(70-100 mg/dl), prolactin(4.79-23.3µg/dL), and cortisol(60.2-184 µg/dL) 1 hour before and 1 hour after the operation.
Time Frame
5 hour
Secondary Outcome Measure Information:
Title
Visual Analog Pain Scale
Description
visual analog for pain consist of a horizontal line, usually 100 mm in length. the left end of the line signifies no pain which is depicted by a smiling face while the right end signifies the worst possible pain with a frowning face. this visual depiction of pain levels helps the patient to communicate about the intensity of their pain.
Time Frame
24 hour
Title
Analgesia period
Description
The time from the end of the operation to the first analgesic requirement was determined as the "analgesia period" and this time was recorded.
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: who will undergo laparoscopic cholecystectomy ASA (American Society of Anesthesiology) I-II 18-65 age group operated between 08:00-12:00 in the morning Exclusion Criteria: Pregnant, Emergency surgery ASA (American Society of Anesthesiology)III-IV Patients who did not consent to the study, History of local anesthetic allergy, Coagulation disorder, Morbid obesity (body mass index >40 kg/m²), Severe organ failure, Previous neurological deficit, Psychiatric disease, Patients with a history of chronic pain Who were switched to the open procedure due to surgical complications during the operation
Facility Information:
Facility Name
Sisli Hamidiye Etfal Training and Research Hospital
City
Sisli
State/Province
Istanbul
ZIP/Postal Code
34376
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Local Anesthetic Infiltration or Erector Spina Plan Block on Stress Hormone Response

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