Erector Spinae Plane Block for Peroperative Analgesia and Intraabdominal Tissue Oxygenation (ESPB)

• ClinicalTrials.gov Identifier: NCT03808129
• Recruitment Status: Completed
• First Posted: January 17, 2019
• Last Update Posted: March 20, 2020
• Sponsor: Bezmialem Vakif University
• Information provided by (Responsible Party): Bezmialem Vakif University

Study Description

Brief Summary:

Brief summary: Regional anesthesia decreases the need for intravenous analgesia in the peri-operative period. Erector spinae plane (ESP) is a regional anesthesia technique shown to be effective at the dorsal and ventral rami of the thoracic spinal nerve along with sympathetic nerve fibers. The purpose is to demonstrate the contribution of ESP block to the postoperative analgesia by ultrasonography and to increase intraabdominal tissue oxygenation compared to the control group.

Condition or disease	Intervention/treatment	Phase
Lower Abdominal Surgery	Drug: Bupivacaine and Lidocaine	Not Applicable

Detailed Description:

50 patients with American Society of Anesthesiologists (ASA) physical score I-II were randomly divided into 25 patients in the ESP group and 25 patients in the control group. Patients were premedicated with oral midazolam 0.5 mg kg-1, 30 minutes before surgery Anesthesia monitorization was made with electrocardiogram, non-invasive blood pressure, peripheral oxygen saturation (SpO2), end-tidal carbon dioxide, temperature, Bispectral index (BIS), and Regional tissue saturation (rSO2). Anesthesia was induced with a face mask distributing 8% sevoflurane and 50% air in oxygen while the patients were breathing spontaneously. After anesthesia induction, peripheral venous access was established and propofol 2 mg kg-1 and fentanyl citrate 1 μg kg-1 were administered. Laryngeal mask airways were used to secure the upper airways. Anesthesia was maintained with sevoflurane and 50% air in oxygen. The concentration of sevoflurane was adjusted by targeting BIS scores at 50-60 in all groups. During the operations, fentanyl was administered at a dose of 0.5 μg kg-1 if the blood pressure and heart rates were 20% higher than the baseline value. In ESP blok groups, after general anesthesia induced, patients were placed in the lateral position and ESP block was performed under ultrasound guidance. For ESP block, 1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine was administered. In all groups, regional tissue saturation (RSO2) was evaluated Continuously with near infrared spectroscopy (NIRS) probe from anesthesia induction to the end of surgery. Commercially available device (INVOS Cerebral Oximeter; somatics Corp, Troy, Mich) was used to monitor rSO2 values in the surgery side flank during surgical intervention. Pain was evaluated and recorded using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at the 1st, 2nd, 8th, 12th and 24th hours. Total analgesic consumption was recorded during the operation and postoperative time to first analgesic drug and number of patients who required analgesic in the first 24 hours, parents satisfaction score, discharge time as well as adverse effects such as nausea and vomiting were recorded in the postoperative periods.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: As the patients were under 18 years of age, the details of the procedure were explained to their parents and their consent was obtained. However, the patients were not included in the group. And also outcomes assessor staff were not aware of medication assignment.
• Primary Purpose: Prevention
• Official Title: The Evaluation of Ultrasonography-guided Erector Spinae Plane Block in Perioperative Analgesia and Intraabdominal Tissue Oxygenation in Pediatric Patients Undergoing Lower Abdominal Surgery
• Actual Study Start Date: January 18, 2019
• Actual Primary Completion Date: April 12, 2019
• Actual Study Completion Date: April 20, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ESP Group: Bupivacaine and lidocaine; ESP Group: Bupivacaine and lidocaine: Erector Spinae Plane Block : (1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine) was administered.	Drug: Bupivacaine and Lidocaine; ESP block was administered under general anesthesia before the surgery. Patients with ESP block, 1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine; Other Name: ESP block
No Intervention: control group; Control Group:

Outcome Measures

Primary Outcome Measures :

1. FLACC scale [ Time Frame: From recovery of anesthesia to end of study ( postoperative 24 hours) ]
   FLACC scale was used. The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale was a measurement used to assess pain for children between the ages of 6 months and 2 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
2. NIRS [ Time Frame: Before anesthesia induction to end of operation ( intraoperative 2 hours ) ]
   INVOS ;Somatic Corp, Troy, Mic sensors placed in surgical side of patients was used to detect peripheral perfusion and oxygen delivery (rSo2)

Secondary Outcome Measures :

1. Time to first analgesic drug [ Time Frame: first 24 hour ]
   Time to first analgesic drug will be recorded
2. Need for analgesic [ Time Frame: first 24 hour ]
   Number of patients who required analgesic in the first 24 hour

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 2 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Children aged 6 months to 2 years
2. According to American Anesthesia Society Anesthesia Risk Scale ASA I-II class patients
3. Patients with lower abdominal surgery

Exclusion Criteria:

1. Children under 6 months and older than 2 years
2. According to American Anesthesia Society Anesthesia Risk Scale Patients with ASA III-IV class
3. Patients with contraindication to regional anesthesia
4. Patients with a history of local anesthetic allergy
5. Patients with abnormal coagulation profile
6. Patients with infection at the injection site

Contacts and Locations

Locations

Turkey

Parvin Pinar

Istanbul, Turkey, 34093

Sponsors and Collaborators

Bezmialem Vakif University

Investigators

• Study Chair: PARVIN PINAR; BEZMİALEM VAKIF UNIVERSITY

More Information

• Responsible Party: Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT03808129
• Other Study ID Numbers: P0001
• First Posted: January 17, 2019
• Last Update Posted: March 20, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bezmialem Vakif University:

erector spinae plane block; postoperative analgesia; RSO2

Additional relevant MeSH terms:

Lidocaine; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action