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

NCT05717530 | Completed

• 1 other identifier: 5234
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain; Erector Spinae Plane Block; Inguinal Hernia

Keywords

Cholecystectomy, Laparoscopic; Erector spinae plane block; analgesia; cortisol; prolactin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analog Pain Scale

  24 hour

• Analgesia period

  24 hour

Study Arms (3)

wound site local anesthesic infiltration

ACTIVE COMPARATOR

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

Procedure: wound site local anesthesic infiltration

Erector spinae plane block

ACTIVE COMPARATOR

: 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

Procedure: Erector spina plane block

Control

NO INTERVENTION

There was no intervention.

Interventions

wound site local anesthesic infiltration PROCEDURE

: 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.

wound site local anesthesic infiltration

Erector spina plane block PROCEDURE

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 spinae plane block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who will undergo laparoscopic cholecystectomy
• ASA (American Society of Anesthesiology) I-II
• age group
• operated between 08:00-12:00 in the morning

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Şişli, Istanbul, 34376, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• murat sahin

  şişli etfal eğitim araştırma hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 8, 2023
• Study Start: February 15, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 7, 2023
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)