Comparison of Analgesic Efficacy of ESP Block and Caudal Block in Patients Undergoing Hypospadias Surgery
Study Details
Study Description
Brief Summary
The goal of clinical trial is to compare in of analgesic efficacy of sacrale erector spinae plane block and caudal block in patients undergoing hypospadias surgery.We will include children between the ages of 6 months and 7 years in the 1st and 2nd categories in the ASA.
In our study, we seek answers to the following questions:
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Which of the sacral erector spinae plane block and caudal block applied to patients undergoing hypospadias surgery has higher postoperative analgesic efficiency than the other?
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Which of the sacral erector spinae plane block and caudal block applied to patients undergoing hypospadias surgery is superior in duration of analgesia? After general anesthesia is administered to the participants, one of the 2 blocks will be administered in a randomized manner and the relevant data will be recorded.Our research will be conducted in a single center as a prospective randomized controlled study. It was planned to include 60 patients from the ASA I-II pediatric patient group aged between 6 months and 7 years, who will undergo hypospadias surgery in our hospital between October 2022 and October 2023, and randomization will be done by closed envelope method. Two groups with sacral ESP and caudal block will be formed, each with 30 patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Our research will be conducted in a prospective randomized controlled in a single center. In our hospital December 2022-December 2023 aged 6 months to 7 years period will be applied to hypospadias surgery, ASA I-II pediatric patient in the group with 60 patients included in the study randomisation was planned to be made and to be sealed. 2 Groups will be formed in which sacral ESP and caudal block are applied so that there will be 30 patients in each.
The study was planned to be performed as a single blind. Accordingly; The application of ESP block and caudal block will be performed by an anesthesiologist who will take part in the perioperative and postoperative management of patients. Since the patient population is a pediatric group, we foresee that the doctor who will closely monitor the patients should have control over the procedure applied to the patient, the dose of local anesthetic applied to the patient, the block making process and the block making time. Parents and surgeons will be unaware of the group to which patients are assigned. Surgeons will not be in the operating room while the anesthesiologist is applying the block (sacral ESP block or caudal block). Spanx and tape will be placed in both block areas (ESP block and caudal block) in all patients. With these measures, it will be ensured that the actual injection site is not known.
The age, height, weight, gender and ASA (American Society of Anaesthesiology) scores of the patients in both groups will be recorded.
After the patients are taken to the operation table, standard monitoring will be performed. Patients's heart rate (HR), mean arterial pressure (OAB), body temperature, peripheral oxygen saturation (SpO2) will be monitored and anaesthesia before induction (basal value), before surgical incision, after surgical incision, before awakening, postoperative 5. - 30. min values will be recorded.
All patients will be placed in an IV cannula using 8% sevoflurane in 50/50 O2 / air for 2 - 4 minutes with a face mask, followed by induction of inhaled anesthesia. All patients will be placed in I-gel (supraglottic airway vehicle) by performing routine induction of general anesthesia with propofol 2-3 mg kg-1, fentanyl 1 mcg kg-1 and appropriate height for weight. Patients will be taken to artificial respiration support and tidal volume will be set to 8- 10 ml/kg and minute breathing will be set to 16-26. The end tidal carbon dioxide will be kept between 35-40 mmHg. Anesthesia maintenance will be provided with a starting dose of sevoflurane 2% and IV remifentanil 0.05 mcg kg-1 min-1 with a flow of 3 Lt min-1, an O₂/air mixture. >25% increase in intraoperative heart rate will be evaluated as pain and remifentanil dose will be increased and the need for remifentanil used intraoperatively will be recorded.
Group ESP (n=30) patients will be given a lateral decubitus position under general anesthesia before the operation and sacral ESP block will be performed accompanied by ultrasound. Group C (n=30) patients who will undergo caudal block will also be given a lateral decubitus position and ultrasound-guided block will be performed. The time required to make the block will be saved.
After block applications 15. min surgery will be initiated. All operations will be performed by the same experienced team with the same surgical technique.
Near the end of the operation, 15 mg kg-1 IV paracetamol will be given. At the end of the operation, the duration of anesthesia and the duration of the operation will be recorded.
After block applications 15. min surgery will be initiated. All operations will be performed by the same experienced team with the same surgical technique.
Near the end of the operation, 15 mg kg-1 IV paracetamol will be given. At the end of the operation, the duration of anesthesia and the duration of the operation will be recorded.
Patients after surgery 5. minutes and 30. minutes and 1. ,2. ,4. ,6. ,12. ,24. on the hours the pain scoring systemFace, Legs, Activity, Cry, Consolability (FLACC) will be recorded. At the end of the operation, the time until the time when there is a need for analgesia will be evaluated as "the first need for analgesia (watch)". Nausea, vomiting, bradycardia, hypotension, itching, local anesthetic toxicity and bleeding that may occur in patients were planned to be recorded.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: GROUP ESP Before the operation, under general anesthesia, group ESP (n=30) patients will be blocked with the sacral ESP block method. By giving the lateral decubitus position, the linear ultrasound probe will be placed in the sterilized area longitudinally on the midline of the sacrum. The erector spinae muscle and the sacral medial crest will be visualized. The 22 gauge, 50 mm needle will be advanced in the direction from cranial to caudal to reach the sacral crest. 0.25% bupivacaine from a dose of 1 mL kg-1 will be aspirated and injected every 2 mL under the erector spina muscle at the level of the median sacral crest at the level of the 4th sacral vertebra. (A test dose will be administered with 1 mL of saline.) |
Procedure: SACRAL ESP AND CAUDAL BLOCK
Application of ultrasound-guided sacral erector spinae plane (ESP) block or ultrasound-guided caudal block with 1mL/kg 0.25% bupivacaine (local anesthetic) to patients
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| Sham Comparator: GROUP C Group C (n=30) patients to whom caudal block will be applied will be placed in the lateral decubitus position and the linear ultrasound probe will be placed longitudinally in the sterilized area on the midline of the sacrum. A 2.5 cm 22 gauge needle will be inserted over the back skin of the sacral hiatus (located distal to the sacrum and formed by the two sacral cornua on its lateral edges) at a 90° position. The sacrococcygeal ligament will be crossed, the needle will be oriented approximately 25° and advanced approximately 2 to 3 mm to reach the sacral canal. After entering the sacral hiatus and confirming the location with negative aspiration method, 1 mL kg-1 0.25% bupivacaine will be injected by aspiration every 2 mL (test dose will be administered with 1 mL saline). |
Procedure: SACRAL ESP AND CAUDAL BLOCK
Application of ultrasound-guided sacral erector spinae plane (ESP) block or ultrasound-guided caudal block with 1mL/kg 0.25% bupivacaine (local anesthetic) to patients
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Outcome Measures
Primary Outcome Measures
- Evaluation of the analgesic effects of sacral ESP and caudal block with Face/ Leg/ Activity/ Cry/ Consolability (FLACC) scores in patients undergoing hypospadias surgery. [1 year]
Evaluation of the analgesic effects of sacral ESP and caudal block with FLACC scores in patients undergoing hypospadias surgery. According to this scoring system, each category is between 0-2, The total score ranges from 0 to 10. 0 points that the game is calm and relaxed, between 1-3 score players are mildly disturbing, scores 4-6 games are moderate He had surgery, scores between 7-10 the player is noticeably disturbing, Pain or harm together reports that.
Eligibility Criteria
Criteria
Inclusion Criteria:
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American Society of Anesthesiology (ASA) I-II group
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6 months to 7 years old
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Paediatric age group patients who will undergo hypospadias surgery under general anesthesia
Exclusion Criteria:
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ASA III - IV patient group
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Patients who were operated on urgently
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Patient relatives who did not give consent
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Presence of local anesthetic allergy
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Presence of infection in the area to be blocked
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Presence of coagulation disorder
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Severe organ failure
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Pre-existing neurological deficit
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Mental Retardation
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Anatomical Deformity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sisli Hamidiye Etfal Research and Training Hospital | Istanbul | Turkey | 34798 |
Sponsors and Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital
Investigators
- Principal Investigator: Sevgi KESİCİ, Sisli Etfal
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 240819