- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05717530
The Effect of Local Anesthetic Infiltration or Erector Spina Plan Block on Stress Hormone Response
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
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Sisli, Istanbul, Turkey, 34376
- Sisli Hamidiye Etfal Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: wound site local anesthesic infiltration
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
|
: 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.
|
Active Comparator: Erector spinae plane block
: 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
|
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.
|
No Intervention: Control
There was no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress hormone response
Time Frame: 5 hour
|
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.
|
5 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Pain Scale
Time Frame: 24 hour
|
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.
|
24 hour
|
Analgesia period
Time Frame: 24 hour
|
The time from the end of the operation to the first analgesic requirement was determined as the "analgesia period" and this time was recorded.
|
24 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: murat sahin, şişli etfal eğitim araştırma hastanesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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