Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202104894849441 Date of Approval: 07/04/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study Between Ultrasound Guided Pudendal Nerve Block And Caudal Epidural Block Anesthesia In Children Undergoing Hypospadias Surgery
Official scientific title Comparative Study Between Ultrasound Guided Pudendal Nerve Block And Caudal Epidural Block Anesthesia In Children Undergoing Hypospadias Surgery
Brief summary describing the background and objectives of the trial Background: The aim of the study is to compare the effectiveness and safety of ultrasound guided pudendal nerve block versus caudal epidural block as a part of multimodal analgesia in children undergoing hypospadias surgery.In this prospective, single-blinded study, 50 patients were randomized into 2 groups (25 each group) either receiving ultrasound-guided pudendal nerve block group A or caudal epidueal block group B . In the pudendal nerve block group, patients were injected with 0.3 mL/kg 0.25% bupivacaine and 1 ug / kg fentanyl. In the caudal epidural group, patients were injected with 1 mL/kg 0.25% bupivacaine and 1 ug/ kg fentanyl. Consumption of paracetamol was assessed during the first 24 hours postoperatively. The “objective pain scale” done by Hannalah and Broadman was used to assess postoperative pain. Results: This prospective randomized controlled single-blind clinical study was performed on total (50) ASA status I or II patients, of age 3 year to 6 years scheduled for hypospadias surgery. For the primary outcome, there was no statistically significant difference found between the two studied groups regarding objective pain score at arrival to PACU with p-value = 1.000 while there was a statistically significant increase in pain score in group B than group A at 6 hours and 12 hours with p-value = 0.017 and 0.003 respectively. Also, no statistically significant difference found between the two groups after 18 hours with p-value = 0.238 may be due to receiving acetaminophen dose in group B. Finally there was a statistically significant increase found in objective pain score in group B at 24 hours than group A with p-value = 0.015. And there was a statistically significant increase in time to first analgesia in group A than group B with p-value <0.001 while there was a statistically significant increase in total dose of acetaminophen in group B than group A with p-value < 0.001. Conclusion: Both Ultrasound guided pudendal block and caudal epidural block are effective and safe methods for postoperative analgesia for children undergoing hypospadias surgery but Ultrasound guided pudendal block gives more postoperative pain control.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/08/2018
Actual trial start date 15/08/2018
Anticipated date of last follow up 15/08/2018
Actual Last follow-up date 01/05/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound Guided Pudendal Nerve Block group A 0.3 mL/kg 0.25% bupivacaine and 1 ug per kg fentanyl 5-10 minutes Patients were put in lithotomy position. An assistant supported the patient’s knees to maintain the position to facilitate performing the block. Two separate injection points were marked at 3 and 9 o’clock, about 2 to 2.5 cm from the center of the anus. After aseptic preparation of the skin, ultrasound guided injection was done. Ultrasound scanning in the transverse plane was used to visualize the ischium forming the lateral border of the sciatic notch. A curvilinear array 2- to 5-MHz transducer was used. By moving the US probe caudally, the ischium became progressively straighter as it transitioned to become the ischial spine. At this level, visualization of the pudendal artery and nerve could be achieved, both lying medial to the spine. 25
Control Group Caudal Epidural Block group B 1 mL/kg 0.25% bupivacaine and 1 ug/ kg fentanyl. 5-7 minutes Patients were put in the lateral decubitus position. After aseptic preparation of the skin, a 2.5 cm 22-gauge needle was inserted at a right angle position to the skin of the back over sacral hiatus (located at the distal part of the sacrum and its lateral margins are formed by the two sacral cornua) until it pierced the sacrococcygeal ligament; the needle was then redirected at about 25° before being advanced to a depth of about 2 to 3 mm into the sacral canal. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Patients aged from 3 to 10 years. -Patients ASA I or II undergoing hypospadias surgery. -Patients parental refusal. -Patients below or above the age. -Patients with bleeding and coagulation disorders. -Patients with muscle diseases. -Patients with vertebral anomalies or any neurological deficit. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 10 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/08/2018 Ain Shams University Faculty of medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Abbasia,Cairo Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome primary outcome is pain measurement by objective pain score and compare pain score between caudal block and pudendal nerve block preoperative, intraoperative and postoperative
Secondary Outcome postoperative need for boluses for pain management and the use of paracetamol in postoperative period in case of pain score more than 2 /10 At arrival to PACU At 6 hr postoperative At12 hr postoperative At18 hr postoperative At24 hr postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university Faculty of medicine Abbasia St, Cairo Cairo 11951 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
MOHAMED HAMED ABD EL AZIZ Abbasia, Cario Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Faculty of Medicine Abbasia, Cairo Cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Hamed Abd El Aziz Abbasia,Cairo Cairo 11591 Egypt
Waleed Abdalla Ibrahim Ahmed Abbasia,Cairo Cairo 11591 Egypt
Mohamed Hossam Eldin Hamdy Abd El Wahab Shokier Abbasia,Cairo Cairo 11591 Egypt
Amr Ahmed Ali Kasem Abbsia,Cairo Cairo 11591 Egypt
Sherif Gorge Anees Saed Abbasia, Cairo Cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Hamed ert.bas.mh@gmail.com 01097288459 Abbasia,Cairo
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Waleed Abdalla drwalidabdullah@yahoo.com 01223198866 Abbasia,Cairo
City Postal code Country Position/Affiliation
Cairo 11591 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries Sherif Gorge sherifganis@hotmail.com 01222421674 Abbasia,Cairo
City Postal code Country Position/Affiliation
Cairo 11591 Egypt assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available the primary outcome is pain measurement by objective pain score the secondary outcome is the use of paracetamol or boluses of local anesthetics to provide postoperative analgesia in case of pain score 2/10 Study Protocol not applicable not applicable the primary outcome is pain measurement by objective pain score the secondary outcome is the use of paracetamol or boluses of local anesthetics to provide postoperative analgesia in case of pain score 2/10
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 27/03/2021 27/03/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 27/03/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information