Clinical trial NCT05717530: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Erector Spinae Plane Block
Inguinal Hernia
Keywords: Cholecystectomy, Laparoscopic
Erector spinae plane block
analgesia
cortisol
prolactin
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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,
* Diabetes Mellitus
* 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

Primary outcomes:
measure: Stress hormone response
timeFrame: 5 hour
Secondary outcomes:
measure: Visual Analog Pain Scale
timeFrame: 24 hour
measure: Analgesia period
timeFrame: 24 hour
Other outcomes:
Locations:
city: Sisli
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
state: Istanbul
Study officials:
affiliation: şişli etfal eğitim araştırma hastanesi
name: murat sahin
role: PRINCIPAL_INVESTIGATOR
References: