Comparison of Two Different Analgesic Regional Block Techniques in Pediatric Patients Undergoing a Hernia Repair

NCT ID: NCT05896072

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2023-12-31

Brief Summary

Lower abdominal operations; especially inguinal hernia repairs are one of the most frequently performed operations in the daily practice of pediatric surgeries.Regional anesthesia techniques are frequently and effectively used methods in postoperative pain control. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae plane block and caudal block in pediatric unilateral inguinal hernia operations

Detailed Description

Patient mobilization and providing adequate analgesia are important components of perioperative care in the day case procedures.Providing adequate postoperative analgesia in the pediatric age group is also important in terms of future pain perception and the development of chronic pain in the next period. Regional anesthesia techniques are very effective and frequently used methods in pain control in children.While central blocks such as caudal epidural block, spinal block are frequently used in inguinal surgeries in children, they have been used in peripheral blocks and successful results have been obtained. Although central blocks are frequently used in the pediatric population, depending on the relevant surgical site, due to the difficulty of application and the capacity to create motor block, the peripheral blocks are among the alternative methods. Although ESP (Erector spinae plane) block is an interfascial plane block, anatomical studies support the idea that some of its clinical benefit may be due to its extension into the paravertebral and epidural space. Its use for pediatric abdominal surgeries has also been reported. Simple randomization will be used in randomization. With 5% margin of error, 80% Power, the standard effect size was determined as 0,72. Pediatric patients in the ASA I-II group, aged 1-8 years, who will undergo elective unilateral inguinal hernia operation under general anesthesia, will be sufficient to include n= 30 cases in each group.The investigators plan to conduct a prospective randomized controlled study for pediatric day case inguinal hernia surgeries. Oral midazolam (0.5 mg/kg) will be given to all children as premedication. After standard monitoring with pulse oximetry, electrocardiography and noninvasive blood pressure measurement in the operating room, anesthesia will be induced with air in 8% sevoflurane and 50% oxygen. Then, a 24-gauge intravenous (iv) cannula will be placed and 1 µg/kg fentanyl and 2-3 mg/kg propofol will be administered for anesthesia induction. The airway will be secured with the ProSeal laryngeal mask airway (Intravent-Orthofix, Maidenhead, UK). Anesthesia will be maintained with 50% nitrous oxide and 2% sevoflurane in oxygen. Additional opioid medication use during the operations will be recorded. At the end of the surgery, all patients will be given acetaminophen 10 mg/kg iv for postoperative analgesia. All blocks will be done after the airway is secured before the surgery begins. Patients will be placed in the side-lying position for ESP block. Following skin preparation with 10% povidone iodine, the ultrasound probe will be placed 1-2 cm lateral to the midline at the sacral level. L1 level will be determined by counting upwards from the sacrum. After identification of the erector spinae muscle (ESM) and the transverse process, a block needle will be inserted deep into the ESM in the cranio-caudal direction using an in-plane technique. Correct needle position will be confirmed by the application of 0.5-1 ml local anesthetic (LA). For block efficacy a pre-calculated dose (0.5 ml/kg) of 0.25% bupivacaine (maximum dose is limited to 20 ml) will be used. In the caudal group the patients will be placed in the side-lying position for the caudal block. The sacral cornues will be palpated and the block needle will be advanced at an angle of 45 degrees.After the needle hits the sacrum the angle will be reduced and retract few millimeters in the epidural space in the sacral canal. It will be checked that there is no blood and cerebrospinal fluid with negative aspiration. Bupivacaine will be administered at the same dose, at a dose of %0.25, 0.5 ml/kg (the maximum dose is limited to 20 ml). A pain nurse was scheduled to assess pain using the Face, Legs, Activity, Crying, and Consolability (FLACC) scores both in the postoperative recovery room and in the ward. FLACC scores will be recorded at 0, 1, 2, 4, 6, 12, and 24 hours postoperatively. Additional analgesia was planned according to the FLACC scores of the patients. If the FLACC score is between 2 and 4, acetaminophen 10 mg/kg iv was planned as additional analgesia in the ward, and tramadol 1 mg/kg iv was planned as an additional analgesic if the FLACC score was > 4. Patients can be discharged after 6 hours postoperatively. Parents will be informed about pain assessment and instructed to give 10 mg/kg oral acetaminophen if FLACC scores are between 2 and 4, and 7 mg/kg oral ibuprofen if FLACC scores are 4 or more. Analgesic requirements in the first 24 hours postoperatively, time to first analgesia, and parental satisfaction with analgesia provided will be recorded at postoperative follow-up visits by one of the anesthetists who are unfamiliar with the study groups. Parental satisfaction levels will be recorded as a numerical scale from 1 to 10; 1 will represent the lowest possible satisfaction level and 10 the highest satisfaction level.

Conditions

Post Operative Pain; Inguinal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ESP Group

Erector Spinae Plane Block Group

Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks

Group Type: EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type: PROCEDURE

Application of ultrasound-guided erector spinae plane block for perioperative analgesia for elective inguinal hernia repair. Erector spinae plane block will be administered under general anesthesia before the surgery

Drug: Bupivacaine (Block Drug)

For block performances, 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc).

Caudal Group

Caudal Block Group

Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks

Group Type: ACTIVE_COMPARATOR

Caudal Block

Intervention Type: PROCEDURE

Application of caudal block for perioperative analgesia for elective inguinal hernia repair. The caudal block will be administered under general anesthesia before the surgery.

Drug: Bupivacaine (Block Drug)

0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc) for block performances

Interventions

Erector Spinae Plane Block

Application of ultrasound-guided erector spinae plane block for perioperative analgesia for elective inguinal hernia repair. Erector spinae plane block will be administered under general anesthesia before the surgery

Drug: Bupivacaine (Block Drug)

For block performances, 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc).

Intervention Type: PROCEDURE

Caudal Block

Application of caudal block for perioperative analgesia for elective inguinal hernia repair. The caudal block will be administered under general anesthesia before the surgery.

Drug: Bupivacaine (Block Drug)

0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc) for block performances

Intervention Type: PROCEDURE

Other Intervention Names

Caudal Epidural Block

Eligibility Criteria

Inclusion Criteria

• Pediatric patient scheduled for unilateral elective inguinal hernia operation
• ASA status 1-2

Exclusion Criteria

• Pediatric patient's parents refusal
• Contraindications to regional anesthesia
• Known allergy to local anesthetics,
• Bleeding diathesis,
• Severe kidney or liver disease
• Presence of infection at the needle entry site.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karabuk University

OTHER

Sponsor Role: collaborator

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role: collaborator

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenan Kart, MD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University Training and Research Hospital

Kasım İlker İtal

Role: STUDY_DIRECTOR

Bolu Abant University Hospital

Duygu Taskin

Role: STUDY_CHAIR

Karabuk University Training and Research Hospital

Locations

Abant İzzet Baysal Education and Training Hospital

Bolu, Merkez, Turkey (Türkiye)

Site Status: RECRUITING

Bolu Abant İzzet Baysal Medical School

Bolu, , Turkey (Türkiye)

Site Status: RECRUITING

Bolu Abant İzzet Baysal University Faculty of Medicine

Bolu, , Turkey (Türkiye)

Site Status: RECRUITING

Karabuk University Karabuk Training and Research Hospital

Karabük, , Turkey (Türkiye)

Site Status: RECRUITING

Karabuk University Training and Research Hospital

Karabük, , Turkey (Türkiye)

Site Status: RECRUITING

Karabuk University Training and Research Hospital

Karabük, , Turkey (Türkiye)

Site Status: RECRUITING

Karabük University Training and Research Hospital

Karabük, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Kenan Kart, MD

Role: CONTACT

kenankart@karabuk.edu.tr

+905337723300

Ilker Ital, MD

Role: CONTACT

ilkerital@gmail.com

+905337723300

Facility Contacts

Ilker Ital, MD

Role: primary

ilkerital@gmail.com

(0374) 253 46 56

Ilker Ital, MD

Role: primary

ilkerital@gmail.com

+905337723300

Tacettin Ayanoglu, MD

Role: backup

ilkerital@gmail.com

+905312331970 ext. İtal

Kenan Kart, MD

Role: primary

kenankart@karabuk.edu.tr

+90 5063849983

Duygu Taskin, MD

Role: backup

duygutaskin@karabuk.edu.tr

+90 5386606553

Kenan Kart, MD

Role: primary

kenankart@karabuk.edu.tr

+90 5063849983

Duygu Taskin, MD

Role: backup

duygutaskin@karabuk.edu.tr

+90 5386606553

Kenan Kart, MD

Role: primary

kenankart@karabuk.edu.tr

+90 5063849983

Duygu Taskin, MD

Role: backup

duygutaskin@karabuk.edu.tr

+90 5386606553

Kenan Kart, MD

Role: primary

kenankart@karabuk.edu.tr

+90 5063849983

Duygu Taskin, MD

Role: backup

duygutaskin@karabuk.edu.tr

+90 5386606553

References

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

Reference Type: BACKGROUND

PMID: 27501016 (View on PubMed)

Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.

Reference Type: RESULT

PMID: 30851499 (View on PubMed)

Cosarcan SK, Mahli A. [Comparison of intraoperative and postoperative analgesic properties of ilioinguinal/iliohypogastric and sacral epidural block in pediatric unilateral inguinal hernia operations]. Agri. 2022 Jan;34(1):38-46. doi: 10.14744/agri.2021.48254. Turkish.

Reference Type: RESULT

PMID: 34988963 (View on PubMed)

Other Identifiers

AIBU-TF-AR-II-003

Identifier Type: -

Identifier Source: org_study_id