Effects of Erector Spinae Plane and Caudal Block on Postoperative Stress Response

NCT05633173 | Completed

• 1 other identifier: 7931
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Inguinal hernia surgery is the most common practice of pediatric surgeons in their clinical practice. As these operations are usually day case procedures, maintaining adequate analgesia is an important component of perioperative care and ERAS protocols. Caudal block, which is one of the analgesic methods used for postoperative pain, is the most frequently used in inguinal hernia surgery and its effectiveness has been proven. Erector spina plane block, which is easy to apply and has a low risk of side effects, is another tool used in the treatment of postoperative pain after inguinal hernia surgery. These are the procedures that are routinely applied in our center with the aim of intraoperative and postoperative effective analgesia.

Conditions

Post Operative Pain; Stress Response; Erector Spinae Plane Block; Caudal Block

Keywords

Pediatric regional anesthesia; Erector spina plane block; Caudal block; Surgical stress hormone

Outcome Measures

Primary Outcomes (1)

• Stress Response

  serum concentration of Cortisol, serum concentration of Prolactin

  3 hours

Secondary Outcomes (4)

• FLACC scores

  24 hours

• Analgesic Consumption

  24 hours

• Analgesia Time

  24 hours

• Complications

  24 hours

Study Arms (2)

Group E

EXPERIMENTAL

Ultrasound-guided erector spina plan block was performed for patients in group E for postoperative analgesia. The patients were placed in the lateral decubitus position and the linear ultrasound probe was placed longitudinally into the sterilized area 1-2 cm lateral to the spinous process of the L1 vertebra. After visualizing the erector spina muscle and the transverse process, the transverse process was reached by pushing forward the 22 gauge, 50 mm needle in the direction from cranial to caudal. Hydrodissection was performed with 1 ml of saline for confirmation. 0.5 mL kg-1 dose of 0.25% bupivacaine was injected under the erector spina muscle at the level of the 1st lumbar vertebra by aspiration every 2 mL.

Procedure: Ultrasound-guided erector spinae plan block

Group C

ACTIVE COMPARATOR

The patients in group C underwent ultrasound guided caudal block for postoperative analgesia. By placing the patients in the lateral decubitus position, the linear ultrasound probe was placed longitudinally on the sterilized area on the midline of the sacrum, and access was provided with a 2.5 cm 22 gauge needle on the dorsal skin of the sacral hiatus at a 90° position. The sacrococcygeal ligament was crossed, the needle was oriented approximately 25° and advanced approximately 2 to 3 mm to reach the sacral canal. When it was understood that the sacral hiatus had been entered, 0.5 mL kg-1 0.25% bupivacaine was injected by aspirating every 2 mL after the location was confirmed with the negative aspiration method.

Procedure: Ultrasound-guided caudal block

Interventions

Ultrasound-guided erector spinae plan block PROCEDURE

Ultrasound-guided erector spina plan block was performed for patients in group E for postoperative analgesia. The patients were placed in the lateral decubitus position and the linear ultrasound probe was placed longitudinally into the sterilized area 1-2 cm lateral to the spinous process of the L1 vertebra. After visualizing the erector spina muscle and the transverse process, the transverse process was reached by pushing forward the 22 gauge, 50 mm needle in the direction from cranial to caudal. Hydrodissection was performed with 1 ml of saline for confirmation. 0.5 mL kg-1 dose of 0.25% bupivacaine was injected under the erector spina muscle at the level of the 1st lumbar vertebra by aspiration every 2 mL.

Group E

Ultrasound-guided caudal block PROCEDURE

The patients in group C underwent ultrasound guided caudal block for postoperative analgesia. By placing the patients in the lateral decubitus position, the linear ultrasound probe was placed longitudinally on the sterilized area on the midline of the sacrum, and access was provided with a 2.5 cm 22 gauge needle on the dorsal skin of the sacral hiatus at a 90° position. The sacrococcygeal ligament was crossed, the needle was oriented approximately 25° and advanced approximately 2 to 3 mm to reach the sacral canal. When it was understood that the sacral hiatus had been entered, 0.5 mL kg-1 0.25% bupivacaine was injected by aspirating every 2 mL after the location was confirmed with the negative aspiration method.

Group C

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA (American Society of Anesthesiologists) class I-II patients
• Patients aged 1 - 6 years
• Patients who will undergo unilateral inguinal hernia surgery

You may not qualify if:

• ASA III - IV patients
• Emergency surgery patients
• Children of parents who did not give consent
• Patients with chronic pain
• Local anesthetic allergy
• Infection in the block area
• Coagulopathy
• Increased intracranial pressure
• Neurological deficit
• Severe organ failure
• Mental retardation
• Anatomical deformities

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Sisli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Fractures, Stress

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Study Officials

• Ayşe Surhan ÇINAR

  Sisli Hamidiye Etfal Research and Training Hospital

  STUDY CHAIR

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: Medical doctor

Model Details: The patients to be included in the study were randomized into two groups, Group E and C, using the closed envelope method in the preoperative period.

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 1, 2022
• Study Start: December 6, 2022
• Primary Completion: February 25, 2023
• Study Completion: March 5, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)