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

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05717530
• Other study ID #: 5234
• Status: Completed
• Phase: N/A
• Start date: February 3, 2023
• Est. completion date: June 7, 2023

Study information

• Verified date: March 2024
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 7, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• 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.
• Erector spina 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.

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Training and Research Hospital	Sisli	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 hour
Secondary	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.	24 hour
Secondary	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.	24 hour