- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07240064
Erector Spinae Plane Block Versus Modified Thoracoabdominal Nerve Block for Analgesia in Pediatric Laparoscopic Abdominal Surgeries
Erector Spinae Plane Block Versus Modified Thoracoabdominal Nerve Block for Analgesia in Pediatric Laparoscopic Abdominal Surgeries: a Prospective, Randomized Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective randomized double blinded controlled study was carried out on 50 pediatric patients who scheduled to undergo elective laparoscopic abdominal surgeries admitted to Cairo University Specialized Children Hospital in the duration from …...to…...after the approval of ethical committee. Group M-TAPA (group A) (n=25): Patients received M-TAPA block after induction of GA.
• Group ESPB (group B) (n=25): Patients received ESPB after induction of GA. Patients and outcome assessors were blinded to the group of the patients. A pharmacist who is not involved in the study prepared the interventional medications. Methods
Preoperative assessment:
Medical and surgical history of the patients were taken, clinical examination of the patients was performed and routine laboratory investigations such as CBC, coagulation studies (INR), renal function (serum creatinine) and liver function (SGPT, SGOT) were done. Each patient was instructed about postoperative pain assessment with the Face, Legs, Activity, Cry and Consolability (FLACC) scale. FLACC (0 represents "no pain" while 10 represents "the maximum pain").
Intraoperative:
On entering the operating room: all patients were connected to standard ASA monitoring which included electrocardiography (ECG), non-invasive arterial blood pressure (NIBP) including systolic, diastolic & mean arterial blood pressure (MAP), Oxygen saturation using pulse oximetry. An intravenous wide pore cannula was inserted in the upper limb then preoperative preload in the form of 10 mL/kg of Ringer's lactate solution for 15 minutes were given. General anesthesia (GA) was induced with propofol 1.5-2.5 mg/kg, and fentanyl 1µg/kg. After IV Tracrium 0.15 mg/kg, the endotracheal tube was inserted.
Maintaining GA was done with sevoflurane (2%) and 50% oxygen. Incremental doses of IV Tracrium 0.03mg/Kg will be given. The cases were then mechanically ventilated to sustain end-tidal CO2 levels of 30-35 mmHg. Additional fentanyl bolus dosages of 0.5 µg/kg IV were administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain). ESPB and M-TAPA were performed after the induction of general anesthesia. Both blocks were performed using ultrasound guidance (FUJiFilM sonosite) with a linear probe (6-13 MHz) under complete aseptic conditions. The blocks were administered before the surgical incision, with a waiting period of at least 30 minutes. ESPB and M-TAPA were performed by an experienced anesthesiologist. Aspiration before injection and test dose injection were performed. Both blocks were performed bilaterally to ensure adequate analgesia for both sides of the abdomen. This was essential to achieve full pain relief for laparoscopic abdominal surgeries, which involve multiple abdominal regions.
In (Group A):
The patient was positioned in a supine posture. A deep angle was given to the costochondral angle at the edge of the 10th costa with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. A 22-G, 50-mm block needle was inserted in the cranial direction using the in-plane technique and the needle tip was moved to the posterior aspect of the 10th costal cartilage. It was noted that the needle tip never crossed the cranial edge of the 10th costal cartilage and 0.4 ml/kg bupivacaine 0.25% were injected into the lower surface of the chondrium. The same process will be repeated for the other side.
In (Group B):
Patients were placed in the lateral decubitus position for block performance. The probe in a sterile sleeve was applied 1-2 cm lateral to the midline to identify the 11-transverse process by counting upward from the sacrum region. After identifying the erector spinae muscle and transverse processes, a 22- gauge, 50 mm nerve block needle were advanced into the target interfacial plane in the craniocaudal direction using the in-plane technique. After confirming the needle placement, 0.4 ml/kg bupivacaine 0.25% were injected. ESPB was considered successful by the linear spread craniocaudally between the tip of the transverse process and the erector spinae muscle. The same process was repeated for the other side.
Postoperative:
Finally, patients were discharged to post anesthesia care unit (PACU). Postoperative pain was assessed by FLACC score Figure 14. A multi-modal analgesic protocol was used for all patients in all groups in the form IV paracetamol 1gm every 6 hrs. Pain intensity was assessed using the FLACC scale which included categories for Face, Legs, Activity, Cry, and Consolability, rated from 0 (no pain) to 10 (maximum pain) at 0.5, 1, 2, 4, 6, 8, 12, and 24 h postoperatively (87). Rescue analgesia of morphine was given as 0.05 to 0.1 mg/kg bolus if the FLACC scale ≥ 4. The maximum dose of morphine was0.2 mg/kg.
Ethical consideration:
Informed consent was obtained from all parents whose children involved in the study. There were adequate provisions to maintain the privacy of participants and confidentiality of the data are as follows:
- The patients were given the option of not participating in the study if they did not want to.
- We put code numbers to each participant with the name and address kept in a special file.
- We hid the patients' names when we use the research.
- We used the results of the study only in a scientific manner and not to use it in any other aims.
Sample size calculation:
The sample size calculation was done by G*Power 3.1.9.2 (Universitat Kiel, Germany). We performed a pilot study (5 cases in each group), and we found that the mean (± SD) Time to first analgesic was 8.2±3.42h in Group ESPB and 4.6±2.7h in Group M-TAPA. The sample size was based on the following considerations: 1.168 effect size, 95% confidence limit, 95% power of the study, group ratio 1:1, and 4 cases were added to each group to overcome dropout. Therefore, we recruited 25 patients in each group. Statistical analysis Statistical analysis was done by SPSS v26 (IBM Inc., Chicago, IL, USA).Shapiro-Wilks test and histograms were used to evaluate the normality of the distribution of data. Quantitative parametric variables were presented as mean and standard deviation (SD) and compared between the two groups utilizing unpaired Student's t- test. Quantitative non-parametric data were presented as median and interquartile range (IQR) and were analyzed by Mann-Whitney test. Qualitative variables were presented as frequency and percentage and were analyzed utilizing the Chi-square test or Fisher's exact test when appropriate. A two tailed P value < 0.05 was considered statistically significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 12345
- Cairo university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age from 2 to 7 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I and II.
- Patients undergoing elective laparoscopic abdominal surgeries under general anesthesia.
Exclusion Criteria:
Known allergies to local anesthetics.
- Pre-existing chronic pain conditions.
- Significant hepatic or renal dysfunction.
- Patients with upper airway infection 2 weeks ago.
- History of developmental delays, mental retardation, or CNS disease.
- Congenital spine anomaly.
- Patients with bleeding and coagulation disorders (e.g., platelet count <100,000/mm³, INR > 1.5).
- Contraindications to regional anesthesia (
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Erector spinae plane block
|
Patients were placed in the lateral decubitus position for block performance.
The probe in a sterile sleeve was applied 1-2 cm lateral to the Patients and Methods 44 midline to identify the 11-transverse process by counting upward from the sacrum region.
After identifying the erector spinae muscle and transverse processes, a 22- gauge, 50 mm nerve block needle were advanced into the target interfacial plane in the craniocaudal direction using the in-plane technique.
After confirming the needle placement, 0.4 ml/kg bupivacaine 0.25% were injected.
ESPB was considered successful by the linear spread craniocaudally between the tip of the transverse process and the erector spinae muscle.
The same process was repeated for the other side.
|
|
Active Comparator: Modified thoracoabdominal plane block
|
The patient was positioned in a supine posture.
A deep angle was given to the costochondral angle at the edge of the 10th costa with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline.
A 22-G, 50-mm block needle was inserted in the cranial direction using the in-plane technique and the needle tip was moved to the posterior aspect of the 10th costal cartilage.
It was noted that the needle tip never crossed the cranial edge of the 10th costal cartilage and 0.4 ml/kg bupivacaine 0.25% were injected into the lower surface of the chondrium.
The same process will be repeated for the other side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first analgesic request (hours)
Time Frame: 24 hours
|
Time to first analgesic request (hours)
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary outcome
Time Frame: 24 hours
|
Pain score assessed by FLACC score..
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MD-154-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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