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Effects of Subcostal TAP Block and Local Anesthetic Infiltration After Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Pain, Subcostal Transversus Abdominis Plane Block, Gall Bladder Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound guided subcostal transversus abdominis plane block
Wound site local anesthetic infiltration
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 Postoperative Pain focused on measuring Cholecystectomy, Laparoscopic, Subcostal Transversus Abdominis 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 I-II 18-65 age group Exclusion Criteria: Pregnant Emergency surgery ASA III-IV History of local anesthetic allergy Coagulative disorder Corticosteroid use Severe psychiatric disease History of chronic pain Uncooperative patients Neurological deficit

Sites / Locations

  • Sisli Hamidiye Etfal Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound guided subcostal transversus abdominis plane block

Wound site local anesthetic infiltration

Arm Description

After the induction of anesthesia, before the beginning of the operation, the subcostal transversus abdominis region is going to be detected under ultrasound guidance and 25-30 ml of 0.25% bupivacaine will be administered

After induction of anesthesia, before the beginning of the operation, a total of 20 ml of 0.25% bupivacaine is going to be infiltrated in equal doses to the four regions that will have trocar access.

Outcomes

Primary Outcome Measures

VAS score
Patients are going to be evaluated for 24 hours postoperatively with recording of abdominal pain using the standard 10-cm visual analogue scale (VAS). VAS score is evaluated between 0 to 10, higher score means worse pain.

Secondary Outcome Measures

Stress hormone response
Blood is going to be taken and recorded in a yellow capped gel biochemistry tube (SSTM II Advance Tubes) for the measurement of stress hormone glucose (70-100mg/dl), prolactin (4.79-23.3µg/dl), cortisol (60.2-184µg/dl) 1 hour before and 1 hour after the operation
Analgesia period
The time from the end of the operation to the first analgesic requirement was determined as the "analgesic period" and this time is going to be recorded

Full Information

First Posted
March 3, 2023
Last Updated
July 28, 2023
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05769881
Brief Title
Effects of Subcostal TAP Block and Local Anesthetic Infiltration After Laparoscopic Cholecystectomy
Official Title
The Effects of Subcostal Transversus Abdominis Plane Block and Local Anesthetic Infiltration on Post-operative Stress Hormone and Pain Relief After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Actual)
Primary Completion Date
October 25, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

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 surgery is an intra-abdominal surgery that is frequently used in the treatment of gallbladder-related pathologies. Compared to open surgery, the cost, the risk of bleeding, the risk of surgical site infection are lower, the need for hospitalization is shorter, and the recovery is rapid. Adequate pain relief is very important after laparoscopic cholecystectomy. Inadequate analgesia in post-operative period has been associated with pain-related cognitive dysfunction, atelectasis, thromboembolic events, increased surgery-related stress response, prolonged hospital stay, and chronic pain in patients. Acetaminophen, non-steroidal anti-inflammatory drugs, opioid analgesics, intraperitoneal washing, local anesthesia infiltration and various regional anesthesia techniques can be used for appropriate analgesia. Studies have shown that subcostal transversus abdominis block has good analgesic efficacy in laparoscopic cholecystectomy surgeries. In the perioperative and postoperative period, afferent nerve signals in the surgical incision area stimulate the hypothalamus, causing the release of CRH, arginine vasopressin, and cortisol depending on the size of the surgical procedure. Providing patients with appropriate postoperative analgesia reduces the release of the stress hormones cortisol and prolactin. In this study, the investigators are aiming to compare the post-operative analgesic affects and stress hormone responses of subcostal transversus abdominis plane block and local anesthetic infiltration in patients undergoing laparoscopic surgery. The study is planned to be prospective, randomized and single-blind.
Detailed Description
Laparoscopic cholecystectomy surgery is an intra-abdominal surgery that is frequently used in the treatment of gallbladder-related pathologies. With the widespread use of laparoscopic procedures, open surgery has been replaced by laparoscopic cholecystectomy. Compared to open surgery, the cost, the risk of bleeding, the risk of surgical site infection are lower, the need for hospitalization is shorter, and the recovery is rapid. Post-abdominal pain is carried by T6-L1 thoracolumbar nerves. Pain after laparoscopic cholecystectomy has both visceral and parietal components, and patients are generally more bothered by visceral pain after surgery. Visceral pain arises from intraperitoneal inflammation and increases with coughing, respiratory effort, and mobilization in the post-operative period, and inadequate analgesia in this period has been associated with pain-related cognitive dysfunction, atelectasis, thromboembolic events, increased surgery-related stress response, prolonged hospital stay, and chronic pain in patients. Acetaminophen, non-steroidal anti-inflammatory drugs, opioid analgesics, intraperitoneal washing, local anesthesia infiltration and various regional anesthesia techniques can be used for appropriate analgesia. Studies have shown that subcostal transversus abdominis block has good analgesic efficacy in laparoscopic cholecystectomy surgeries. In the perioperative and postoperative period, afferent nerve signals in the surgical incision area stimulate the hypothalamus, causing the release of CRH, arginine vasopressin, and cortisol depending on the size of the surgical procedure. Providing appropriate postoperative analgesia in patients decreased the release of stress hormones cortisol and prolactin. In this study, the investigators are aiming to compare the effects of subcostal transversus abdominis block and local anesthetic infiltration on postoperative analgesia and stress hormone response in patients who underwent laparoscopic cholecystectomy surgery. The study is planned to be prospective, randomized and single-blind.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Subcostal Transversus Abdominis Plane Block, Gall Bladder Disease
Keywords
Cholecystectomy, Laparoscopic, Subcostal Transversus Abdominis 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
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided subcostal transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
After the induction of anesthesia, before the beginning of the operation, the subcostal transversus abdominis region is going to be detected under ultrasound guidance and 25-30 ml of 0.25% bupivacaine will be administered
Arm Title
Wound site local anesthetic infiltration
Arm Type
Active Comparator
Arm Description
After induction of anesthesia, before the beginning of the operation, a total of 20 ml of 0.25% bupivacaine is going to be infiltrated in equal doses to the four regions that will have trocar access.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided subcostal transversus abdominis plane block
Intervention Description
After the induction of anesthesia, before the beginning of the operation, the subcostal transversus abdominis region is going to be detected under ultrasound guidance and 25-30 ml of 0.25% bupivacaine will be administered
Intervention Type
Procedure
Intervention Name(s)
Wound site local anesthetic infiltration
Intervention Description
After induction of anesthesia, before the beginning of the operation, a total of 20 ml of 0.25% bupivacaine is going to be infiltrated in equal doses to the four regions that will have trocar access
Primary Outcome Measure Information:
Title
VAS score
Description
Patients are going to be evaluated for 24 hours postoperatively with recording of abdominal pain using the standard 10-cm visual analogue scale (VAS). VAS score is evaluated between 0 to 10, higher score means worse pain.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Stress hormone response
Description
Blood is going to be taken and recorded in a yellow capped gel biochemistry tube (SSTM II Advance Tubes) for the measurement of stress hormone glucose (70-100mg/dl), prolactin (4.79-23.3µg/dl), cortisol (60.2-184µg/dl) 1 hour before and 1 hour after the operation
Time Frame
5 hours
Title
Analgesia period
Description
The time from the end of the operation to the first analgesic requirement was determined as the "analgesic period" and this time is going to be recorded
Time Frame
24 hours

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 I-II 18-65 age group Exclusion Criteria: Pregnant Emergency surgery ASA III-IV History of local anesthetic allergy Coagulative disorder Corticosteroid use Severe psychiatric disease History of chronic pain Uncooperative patients Neurological deficit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ilay cetiner
Phone
+905378783939
Email
ilaycetiner@gmail.com
Facility Information:
Facility Name
Sisli Hamidiye Etfal Training and Research Hospital
City
Sisli
State/Province
Istanbul
ZIP/Postal Code
34381
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ilay cetiner
Phone
+905378783939
Email
ilaycetiner@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Subcostal TAP Block and Local Anesthetic Infiltration After Laparoscopic Cholecystectomy

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