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

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05717530

Collaborator

(none)

Enrollment

Location

Arms

3.1

Anticipated Duration (Months)

29.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Erector Spinae Plane Block Inguinal Hernia	Procedure: wound site local anesthesic infiltration Procedure: Erector spina plane block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 3, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 7, 2023

Arms and Interventions

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	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.
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	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.
No Intervention: No additional procedures were applied to the patients No additional procedures were applied to the patients

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

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.

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

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.

No Intervention: No additional procedures were applied to the patients

No additional procedures were applied to the patients

Outcome Measures

Primary Outcome Measures

Stress hormone response [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.

Secondary Outcome Measures

Visual Analog Pain Scale [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.
Analgesia period [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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