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Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children

Primary Purpose

Anesthesia, Anesthesia, Local, Analgesia

Status
Not yet recruiting
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Caudal block
Dorsal penile nerve block plus ring block
Circumcision with Plastibell
Conventional Dissection Method
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia

Eligibility Criteria

3 Months - 4 Years (Child)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy,
  2. Male,
  3. Ages 3 months to 4 years,
  4. Scheduled for circumcision for various indications under GA.

Exclusion Criteria:

  1. Patients with bleeding or clotting disorders
  2. Patients with hypospadias, other penile or sacral anomalies
  3. Patients weight <3kg.
  4. Allergy to Local Anesthetic
  5. Infection at the site of block
  6. Pre-existing spinal or neurological disease
  7. Pain medication within the previous 48 hours

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Caudal block and circumcision with Plastibell,

Caudal block and circumcision with conventional dissection method

Dorsal penile nerve block plus ring block and circumcision with Plastibell

Dorsal penile nerve block plus ring block and circumcision with conventional dissection method

Arm Description

Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using plastibell. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.

Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using the conventional dissection method. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.

Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using plastibell.

Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method

Outcomes

Primary Outcome Measures

Efficacy of analgesia using FLACC Scale
Postoperatively in the PACU, the child will be observed in the recovery room by a senior nurse blinded to the anesthetic technique and the FLACC score will be used for pain assessment (copy attached). The FLACC scale is a uni-dimensional behavioral pain assessment instrument to measure pain in young children in the post-OP period. It includes five items (Face, Leg, Activity, Cry, and Consolability) and has good inter-rater reliability (Kappa 0.52-0.82), as well as good content and convergent validity. The scale is scored in a range of 0-10 with 0 = no pain and 10 = severe pain. The FLACC is reliable in critically ill young children. The severity of pain will be classified using the total score 0=no pain, and 10= severe pain. I.V fentanyl will be administered in the dose of 0.5 mic/kg if the pain score is >5 and the dose will be repeated if the FLACC score persisted >5 after five minutes.
Duration of analgesia
To compare the duration of post-OP analgesia produced by CB and DPNB plus RB in children undergoing circumcision with two different surgical techniques.

Secondary Outcome Measures

Number of participants that needed rescue analgesia
Number of participants that needed rescue analgesia in PACU and ward
Motor block score
Motor block score will be recorded (0=spontaneous movements of hips, knees and ankles, 1=movements of knees and ankles but no movements of hips, 2=only movements of ankles, and 3=no movements of lower limbs).
Blood pressure (mm/Hg)
Patients will receive fentanyl 0.5 mic/kg, if at any stage HR or BP increased 25% more than baseline value and the total dose of rescue analgesia received intra-operatively will be recorded.
Heart rate (beats/min)
Patients will receive fentanyl 0.5 mic/kg, if at any stage HR or BP increased 25% more than baseline value and the total dose of rescue analgesia received intra-operatively will be recorded.
Time to discharge from PACU
Amount of time the patient stays in PACU after the surgery. This will be a continuous variable (time).
Number of patients with infection
Number of patients experiencing infection at site of circumcision. It will be recorded as yes/no.
Number of patients experiencing urinary retention
Measured as: no urine output after intervention.
Number of Participants with sedation
Sedation will be measured using the The Pasero Opioid-Induced Sedation Scale (POSS). POSS is a standardized approach to assessing opioid-induced sedation and instituting interventions. The POSS scores are S ("sleep, easy to arouse"), 1 ("awake and alert"), 2 ("slightly drowsy, easily aroused"), 3 ("frequently drowsy, arousable, drifts off to sleep during conversation"), and 4 ("somnolent, minimal, or no response to verbal or physical stimulation"). Scores of S, 1, or 2 are considered acceptable; the opioid dose may be increased if needed.
Number of Participants with nausea
Will be recorded as yes/no
Number of Participants with vomiting
Will be recorded as yes/no
Number of Participants with agitation
Will be recorded as yes/no
Number of Participants with penile hematoma
Will be recorded as yes/no
Total paracetamol doses administered
Amount of paracetamol required by the patient for pain control

Full Information

First Posted
October 22, 2021
Last Updated
January 31, 2022
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT05233683
Brief Title
Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children
Official Title
Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Circumcision is one of the most commonly performed operations in the pediatric population and is a painful procedure. Circumcision is performed with two popular techniques, Plastibell and conventional dissection method (CDM). For intra-operative (OP) and post-OP pain relief, two commonly used local anesthetic techniques are caudal block (CB) and dorsal penile block (DPNB) plus ring block (RB) at the base of the penis. There are very few randomized controlled trials comparing these two methods of intra-OP and post-OP pain relief, for different surgical techniques and there is a lack of well-conducted studies comparing the quality of analgesia, need for rescue analgesia in the early post-OP period, complications, and parental satisfaction comparing these blocks. Furthermore, there is a lot of contradiction in the literature regarding the duration of analgesia produced with these techniques.
Detailed Description
Circumcision is one of the most commonly performed operations in the paediatric population and is a painful procedure. Circumcision is performed with two popular techniques, Plastibell and conventional dissection method. Two anesthetic techniques are commonly used for intra-operative (OP) and post-OP pain relief i.e CB and DPNB+RB at the base of the penis. Addition of dexmedetomidine to bupivacaine prolongs duration of analgesia of CB. Both anaesthesia techniques of pain relief have certain advantages and disadvantages and the superiority of any technique over the other has not been established. There are very few randomized controlled trials comparing these two methods of intra-OP and post-OP pain relief, for different surgical techniques of circumcision and there is a lack of well-conducted studies comparing the quality of analgesia, need for rescue analgesia in the early post-OP period, complications, and parental satisfaction comparing these blocks. Furthermore, there is a lot of contradiction in the literature regarding the duration of analgesia produced with these techniques. Poorly treated postoperative pain leads to fatigue and metabolic, endocrine, and immunological changes can lead to prolonged convalescence following surgery and is traumatic to the pediatric patients and their parents. In this study, the investigators planned to compare the two most popular methods of pain relief during and after circumcision, along with parents' satisfaction. This research will guide the anesthetists regarding the selection of appropriate techniques of intra-OP and post-OP analgesia and in light of intra and post-OP data; and parents' satisfaction. In this prospective randomized study the investigators plan to compare the quality of intra and post OP analgesia and the duration of post-OP analgesia produced by CB and DPNB +RB, need of rescue analgesia with both of the techniques of surgery, intra-OP hemodynamic variations, residual motor block, and adverse effects and parents' satisfaction with both of the anesthesia and the surgical techniques. Research Objectives: To evaluate and compare the intra and post-OP pain relief under CB and DPNB plus RB in pediatric patients undergoing circumcision with different surgical techniques and assessment of parents' satisfaction This study may guide the anesthetists for the selection of appropriate techniques of intra and post-OP analgesia and their complications for different surgical techniques of circumcision and also about parent's satisfaction with the anesthetic technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Anesthesia, Local, Analgesia, Pediatric ALL, Pain, Postoperative, Pain, Acute

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
All patients will receive general anesthesia. Patients will be randomly allocated to one of 4 arms of the study: Group 1 will receive are caudal block (CB) and circumcision with Plastibell, Group 2 will receive CB and circumcision with conventional dissection method (CDM), Group 3 will receive dorsal penile block (DPNB) and ring block (RB) and circumcision with Plastibell, and Group 4 will receive DPNB+ RB and circumcision with CDM.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caudal block and circumcision with Plastibell,
Arm Type
Experimental
Arm Description
Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using plastibell. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
Arm Title
Caudal block and circumcision with conventional dissection method
Arm Type
Experimental
Arm Description
Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using the conventional dissection method. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
Arm Title
Dorsal penile nerve block plus ring block and circumcision with Plastibell
Arm Type
Active Comparator
Arm Description
Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using plastibell.
Arm Title
Dorsal penile nerve block plus ring block and circumcision with conventional dissection method
Arm Type
Active Comparator
Arm Description
Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method
Intervention Type
Drug
Intervention Name(s)
Caudal block
Intervention Description
Caudal block will be performed in lateral position with 0.25% bupivacaine in the dose of 0.75 ml/kg containing 1 mic/kg dexmedetomidine. The patients will be turned back to the supine position after the block placement and the head of the patient will be placed in the neutral position. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
Intervention Type
Drug
Intervention Name(s)
Dorsal penile nerve block plus ring block
Intervention Description
It will be performed with the child in the supine position. Following skin preparation and palpation of the arch of the lower border of the symphysis pubis, the base of the penis will be gently pulled down, and a 25-G needle will be inserted at 10 and 2.0 "O" clock position to a depth of 0.25-0.5 cm (under Bucks' fascia) and 1 ml + 0.1ml X weight of the patient) of local anesthetic (0.25% bupivacaine) will be injected at each point after negative aspiration and then RB will be done in the form of a circumferential subcutaneous ring at the level of the base of the penis. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
Intervention Type
Procedure
Intervention Name(s)
Circumcision with Plastibell
Intervention Description
Circumcision with Plastibell
Intervention Type
Procedure
Intervention Name(s)
Conventional Dissection Method
Intervention Description
Conventional Dissection Method
Primary Outcome Measure Information:
Title
Efficacy of analgesia using FLACC Scale
Description
Postoperatively in the PACU, the child will be observed in the recovery room by a senior nurse blinded to the anesthetic technique and the FLACC score will be used for pain assessment (copy attached). The FLACC scale is a uni-dimensional behavioral pain assessment instrument to measure pain in young children in the post-OP period. It includes five items (Face, Leg, Activity, Cry, and Consolability) and has good inter-rater reliability (Kappa 0.52-0.82), as well as good content and convergent validity. The scale is scored in a range of 0-10 with 0 = no pain and 10 = severe pain. The FLACC is reliable in critically ill young children. The severity of pain will be classified using the total score 0=no pain, and 10= severe pain. I.V fentanyl will be administered in the dose of 0.5 mic/kg if the pain score is >5 and the dose will be repeated if the FLACC score persisted >5 after five minutes.
Time Frame
First 12 hours after surgery/intervention (circumcision)
Title
Duration of analgesia
Description
To compare the duration of post-OP analgesia produced by CB and DPNB plus RB in children undergoing circumcision with two different surgical techniques.
Time Frame
First 12 hours after surgery/intervention (circumcision)
Secondary Outcome Measure Information:
Title
Number of participants that needed rescue analgesia
Description
Number of participants that needed rescue analgesia in PACU and ward
Time Frame
first 12 hours after surgery (circumcision)
Title
Motor block score
Description
Motor block score will be recorded (0=spontaneous movements of hips, knees and ankles, 1=movements of knees and ankles but no movements of hips, 2=only movements of ankles, and 3=no movements of lower limbs).
Time Frame
first 12 hours after surgery (circumcision)
Title
Blood pressure (mm/Hg)
Description
Patients will receive fentanyl 0.5 mic/kg, if at any stage HR or BP increased 25% more than baseline value and the total dose of rescue analgesia received intra-operatively will be recorded.
Time Frame
during the surgery (from start time to end time of circumcision)
Title
Heart rate (beats/min)
Description
Patients will receive fentanyl 0.5 mic/kg, if at any stage HR or BP increased 25% more than baseline value and the total dose of rescue analgesia received intra-operatively will be recorded.
Time Frame
during the surgery (from start time to end time of circumcision)
Title
Time to discharge from PACU
Description
Amount of time the patient stays in PACU after the surgery. This will be a continuous variable (time).
Time Frame
First 12 hours after surgery (circumcision)
Title
Number of patients with infection
Description
Number of patients experiencing infection at site of circumcision. It will be recorded as yes/no.
Time Frame
First 5 days after surgery (circumcision)
Title
Number of patients experiencing urinary retention
Description
Measured as: no urine output after intervention.
Time Frame
First 12 hours after surgery (circumcision)
Title
Number of Participants with sedation
Description
Sedation will be measured using the The Pasero Opioid-Induced Sedation Scale (POSS). POSS is a standardized approach to assessing opioid-induced sedation and instituting interventions. The POSS scores are S ("sleep, easy to arouse"), 1 ("awake and alert"), 2 ("slightly drowsy, easily aroused"), 3 ("frequently drowsy, arousable, drifts off to sleep during conversation"), and 4 ("somnolent, minimal, or no response to verbal or physical stimulation"). Scores of S, 1, or 2 are considered acceptable; the opioid dose may be increased if needed.
Time Frame
First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Title
Number of Participants with nausea
Description
Will be recorded as yes/no
Time Frame
First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Title
Number of Participants with vomiting
Description
Will be recorded as yes/no
Time Frame
First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Title
Number of Participants with agitation
Description
Will be recorded as yes/no
Time Frame
First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Title
Number of Participants with penile hematoma
Description
Will be recorded as yes/no
Time Frame
First 12 hours after surgery/intervention: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Title
Total paracetamol doses administered
Description
Amount of paracetamol required by the patient for pain control
Time Frame
first 5 days after surgery (circumcision)
Other Pre-specified Outcome Measures:
Title
Parents' satisfaction with pain relief using Likert Scale
Description
Parents' satisfaction with pain relief will be measured using a Likert Scale (0-10)
Time Frame
First 5 days after surgery (circumcision)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Patient eligibility is based on gender identity
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy, Male, Ages 3 months to 4 years, Scheduled for circumcision for various indications under GA. Exclusion Criteria: Patients with bleeding or clotting disorders Patients with hypospadias, other penile or sacral anomalies Patients weight <3kg. Allergy to Local Anesthetic Infection at the site of block Pre-existing spinal or neurological disease Pain medication within the previous 48 hours
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mansoor Aqil, FCPS
Phone
00966507221058
Email
maqil@ksu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansoor Aqil, FCPS
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud University
City
Riyadh
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mansoor Aqil, FRCP
Phone
00966507221058
Email
maqil@ksu.edu.sa
First Name & Middle Initial & Last Name & Degree
Mansoor Aqil
First Name & Middle Initial & Last Name & Degree
Abdulrahman Alzahem
First Name & Middle Initial & Last Name & Degree
Mueen ullah Khan
First Name & Middle Initial & Last Name & Degree
Fatma Dammas
First Name & Middle Initial & Last Name & Degree
Abdulaziz Ahmed
First Name & Middle Initial & Last Name & Degree
Abdul Sattar Narejo
First Name & Middle Initial & Last Name & Degree
Rashid Saeed Khokhar

12. IPD Sharing Statement

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Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children

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