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

NCT ID: NCT05717530

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2023-06-07

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.

Conditions

Post Operative Pain; Erector Spinae Plane Block; Inguinal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

wound site local anesthesic infiltration

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Erector spina plane block

Intervention Type: 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.

Control

There was no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

murat sahin

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

murat sahin

Role: PRINCIPAL_INVESTIGATOR

şişli etfal eğitim araştırma hastanesi

Locations

Sisli Hamidiye Etfal Training and Research Hospital

Şişli, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

5234

Identifier Type: -

Identifier Source: org_study_id