search
Back to results

Comparison of Doses of Dexmedetomidine With Bupivacaine in Caudal Block for Duration of Analgesia in Paediatric Infraumblical Surgeries.

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Dexmedetomidine
Sponsored by
Dr. Ruth K.M. Pfau Civil Hospital, Karachi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Postoperative pain, Regional Anaesthesia, Caudal Block, Dexmedetomidine, Infraumbilical surgeries

Eligibility Criteria

1 Year - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anaesthesiologists (ASA) Status I and II
  • Aged between 1 to 6 years
  • Planned for below umbilicus elective surgery

Exclusion Criteria:

  • Refusal to consent by parent/guardian
  • Injection site infection
  • Coagulation disorders
  • Congenital abnormalities of lower spine and meninges
  • Anticipated difficult airway requiring endotracheal intubation and intermittent positive pressure ventilation
  • Prone position surgical procedures
  • Known drug allergy history

Sites / Locations

  • Dr. Haris Chohan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group C

Group BD1

Group BD2

Arm Description

0.25% bupivacaine at a total volume of 0.5ml/kg.

0.25% bupivacaine + 1mcg/kg dexmedetomidine at a total volume of 0.5ml/kg.

0.25% bupivacaine + 0.5mcg/kg dexmedetomidine at a total volume of 0.5ml/kg.

Outcomes

Primary Outcome Measures

Duration of Analgesia
Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4
Duration of Analgesia
Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4
Duration of Analgesia
Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4
Duration of Analgesia
Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4
Duration of Analgesia
Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

Secondary Outcome Measures

Heart Rate (bradycardia)
heart rate less than 60 beats/min for ages above 1 year.
Heart Rate (bradycardia)
heart rate less than 60 beats/min for ages above 1 year.
Heart Rate (bradycardia)
heart rate less than 60 beats/min for ages above 1 year.
Heart Rate (bradycardia)
heart rate less than 60 beats/min for ages above 1 year.
Heart Rate (bradycardia)
heart rate less than 60 beats/min for ages above 1 year.
Blood Pressure
Decrease in systolic blood pressure < 25% from the baseline
Blood Pressure
Decrease in systolic blood pressure < 25% from the baseline
Blood Pressure
Decrease in systolic blood pressure < 25% from the baseline
Blood Pressure
Decrease in systolic blood pressure < 25% from the baseline
Blood Pressure
Decrease in systolic blood pressure < 25% from the baseline
Postoperative Respiratory Depression
if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.
Postoperative Respiratory Depression
if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.
Postoperative Respiratory Depression
if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.
Postoperative Respiratory Depression
if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.
Postoperative Respiratory Depression
if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.

Full Information

First Posted
January 6, 2021
Last Updated
January 6, 2021
Sponsor
Dr. Ruth K.M. Pfau Civil Hospital, Karachi
search

1. Study Identification

Unique Protocol Identification Number
NCT04700228
Brief Title
Comparison of Doses of Dexmedetomidine With Bupivacaine in Caudal Block for Duration of Analgesia in Paediatric Infraumblical Surgeries.
Official Title
Comparison of Doses of Dexmedetomidine With Bupivacaine in Caudal Block for Duration of Analgesia in Paediatric Infraumblical Surgeries.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Ruth K.M. Pfau Civil Hospital, Karachi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Various methods are used to control post-operative pain among children. Amongst these methods, caudal block is one of the most favoured, prominent and dependable methods for providing reliable analgesia in surgeries below umbilicus. This study is to compare two doses of Dexmedetomidine added as adjunct to local anaesthesia using reduced dose in caudal block for prolonging the duration of analgesia. Our secondary outcomes will include blood pressure, heart rate, urinary retention, nausea and vomiting in the paediatric population.
Detailed Description
Pain is one the most underrated, misunderstood and often underdiagnosed field especially in children. Pain is an unpleasant feeling which is basically a subjective feeling, which in children is poorly expressed. Failure to control pain during childhood ultimately results in having chronic adverse effects which include altered sleep, eating habits and neuroendocrine responses and increased sensitivity to pain in the following pain episodes. Successful postoperative pain management is one of the main pillars of anaesthesia. Regional Anaesthesia has gained a lot of popularity over the past few years in paediatrics. Approximately one-quarter of analgesic procedures currently performed on children are done by regional analgesic techniques. There are various methods that are being currently used to control post-operative pain among children. Amongst these methods, caudal block is one of the most favoured, prominent and dependable methods for providing reliable analgesia in surgeries below umbilicus. However, it has a drawback of being having a limited time of action when used as a single shot technique. This time limit can be increased significantly by the addition of different adjuvants along with local anaesthetic drugs in caudal block, which not only helps the anaesthesiologist in giving a better quality of anaesthesia and analgesia but it leads up to creating a desirable intraoperative environment for the surgeon as well. Better control over intraoperative and post-operative analgesia also helps the anaesthesiologist in giving reduced levels of anaesthesia which caused reduced amount of postoperative sedation as well. Dexmedetomidine has a specific affinity for α2-adrenoreceptor having sedative and analgesic properties, which makes it an ideal adjuvant agent. The landmark ability of this adjuvant is that it causes minimal respiratory depression even at high dosages. A number of studies have been done until now that have proved successfully that dexmedetomidine can be used as an adjuvant in caudal block, in children, in enhancing post-operative analgesia. Although there is insufficient data available, various studies have demonstrated the dose of dexmedetomidine in Caudal Block ranging from 0.5 µg/kg to 2 µg/kg. According to an up to date review anaesthesia will last longer with dexmedetomidine as compared to morphine when used, as haemodynamics were found to be stable mostly when dexmedetomidine was used. However bradycardia was mostly related to a dose of 2 mcg/kg of dexmedetomidine. A study published in 2019 documented a decrease in heart rate, not requiring active management, in the dexmedetomidine group at a dose of 1mcg/kg. Our objective is to compare two doses of Dexmedetomidine added as adjunct to local anaesthesia using reduced dose in caudal block for prolonging the duration of analgesia. Our secondary outcomes will include blood pressure, heart rate, urinary retention, nausea and vomiting in the paediatric population. Patient meeting inclusion criteria visiting paediatric operating room will be inducted in the study. Informed and written consent will be taken from parents/guardian explained about the potential risk and benefits of study. Patients' demographic details like age, sex, and weight will be collected by filling the relevant proforma. A total of 162 patients will be divided into three equal groups randomly by lottery method. The observer and the anaesthesiologist who will induce the patient will be blinded regarding the group in which the patient will be placed. Pre operatively, a detailed history, examination and related laboratory investigations will be seen as a part of hospital pre-operative assessment protocol. On arrival to operation theatre, monitors (SpO2, Pulse Oximeter, NIBP, pre cordial stethoscope and ECG) will be applied. Emergency drugs will be prepared already before the patient arrives in operation theatre. Anaesthesia will be induced with 100% oxygen and sevoflurane 8% using Jackson Rees Circuit. Once the desired depth of anaesthesia is achieved, I/V access will be taken. Propofol 3mg/kg and Nalbuphine 0.1mg/kg will be given and Sevoflurane will be set at 3%. LMA of desirable size will be placed. After this, patient would be placed in lateral position. Sufficient exposure would be done for Caudal Block. After taking all aseptic measures, Caudal Block procedure will be done with help of 23G needle after identifying the anatomical landmarks. Correction position of the needle will be confirmed by swoosh and whoosh test. On aspiration of the syringe if it is negative for CSF and blood, then one of the following drug combinations will be used for the caudal block. Group C (control): 0.25% bupivacaine at a total volume of 0.5ml/kg Group BD1: 0.25% bupivacaine + 1mcg/kg dexmedetomidine at a total volume of 0.5ml/kg Group BD2: 0.25% bupivacaine + 0.5mcg/kg dexmedetomidine at a total volume of 0.5ml/kg After dressing the injection site, the patient will be turned supine. Vitals of the patient including heart rate, blood pressure, SpO2 and respiratory will be recorded before the induction of caudal block and there after every 10 minutes. Inadequate analgesia or unsuccessful block will be labelled if there would be a 20% increase in heart rate of the patient as compared to the baseline recording. If the caudal block is insufficient that case will not be included in the study. Hypotension and bradycardia will be recorded and treated with fluid bolus and atropine respectively. . The first surgical incision would be given 10 mins after the application of caudal block. After the completion of the surgery, inhalation gas will be closed and patient will be given 100% oxygen only. LMA will be removed once the patient is awake and the patient will be shifted to Post Anaesthesia Care Unit (PACU). Here patient's vitals will be monitored and pain will be assessed at 1, 2, 4, 6 and 12 hours after the application of caudal block using FLACC scale16. Time taken for the requirement of first rescue analgesia will also be recorded. Intravenous paracetamol 15mg/kg will be given if FLACC score is more than 4 at any of the above mentioned time. Secondary findings like heart rate, blood pressure, respiratory depression, urinary retention, nausea and vomiting will also be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Postoperative pain, Regional Anaesthesia, Caudal Block, Dexmedetomidine, Infraumbilical surgeries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
Factorial Assignment Anesthesia will be induced with 100% oxygen and sevoflurane 8%. Once achieving the desired depth of anesthesia, I/V access will be taken. Propofol 3mg/kg and Nalbuphine 0.1mg/kg will be given. LMA of desirable size will be placed. After this, patient would be placed in lateral position for caudal Block. After all aseptic measures, Caudal Block procedure will be done with help of 23G needle by anatomical landmarks. On negative aspiration of the syringe, one of the drug combinations as explained under 'arms and intervention' will be used for the caudal block. First surgical incision will be given 10 mins after the application of caudal block. After the completion of surgery, LMA will be removed once the patient is awake and the patient will be shifted to PACU. IV paracetamol 15mg/kg will be given if FLACC score is more than 4 at any point during the surgery.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
0.25% bupivacaine at a total volume of 0.5ml/kg.
Arm Title
Group BD1
Arm Type
Active Comparator
Arm Description
0.25% bupivacaine + 1mcg/kg dexmedetomidine at a total volume of 0.5ml/kg.
Arm Title
Group BD2
Arm Type
Active Comparator
Arm Description
0.25% bupivacaine + 0.5mcg/kg dexmedetomidine at a total volume of 0.5ml/kg.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
We are going to see the effects of dexmedetomidine as an adjunct to bupivacaine in caudal block. In first (control) group (group C) only bupivacaine will be given. Group BD1 patients will be given bupivacaine plus 1mcg/kg dexmedetomidine. Group BD2 patients will get bupivacaine plus 0.5mcg/kg dexmedetomidine. All the groups will be given a volume of 0.5ml/kg.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
We are going to see the effects of dexmedetomidine as an adjunct to bupivacaine in caudal block. In first (control) group (group C) only bupivacaine will be given. Group BD1 patients will be given bupivacaine plus 1mcg/kg dexmedetomidine. Group BD2 patients will get bupivacaine plus 0.5mcg/kg dexmedetomidine. All the groups will be given a volume of 0.5ml/kg.
Primary Outcome Measure Information:
Title
Duration of Analgesia
Description
Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4
Time Frame
1 hour after caudal block
Title
Duration of Analgesia
Description
Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4
Time Frame
2 hours after caudal block
Title
Duration of Analgesia
Description
Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4
Time Frame
4 hours after caudal block
Title
Duration of Analgesia
Description
Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4
Time Frame
6 hours after caudal block
Title
Duration of Analgesia
Description
Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4
Time Frame
12 hours after caudal block
Secondary Outcome Measure Information:
Title
Heart Rate (bradycardia)
Description
heart rate less than 60 beats/min for ages above 1 year.
Time Frame
1 hour after caudal block.
Title
Heart Rate (bradycardia)
Description
heart rate less than 60 beats/min for ages above 1 year.
Time Frame
2 hours after caudal block.
Title
Heart Rate (bradycardia)
Description
heart rate less than 60 beats/min for ages above 1 year.
Time Frame
4 hours after caudal block.
Title
Heart Rate (bradycardia)
Description
heart rate less than 60 beats/min for ages above 1 year.
Time Frame
6 hours after caudal block.
Title
Heart Rate (bradycardia)
Description
heart rate less than 60 beats/min for ages above 1 year.
Time Frame
12 hours after caudal block.
Title
Blood Pressure
Description
Decrease in systolic blood pressure < 25% from the baseline
Time Frame
1 hour after caudal block.
Title
Blood Pressure
Description
Decrease in systolic blood pressure < 25% from the baseline
Time Frame
2 hours after caudal block.
Title
Blood Pressure
Description
Decrease in systolic blood pressure < 25% from the baseline
Time Frame
4 hours after caudal block.
Title
Blood Pressure
Description
Decrease in systolic blood pressure < 25% from the baseline
Time Frame
6 hours after caudal block.
Title
Blood Pressure
Description
Decrease in systolic blood pressure < 25% from the baseline
Time Frame
12 hours after caudal block.
Title
Postoperative Respiratory Depression
Description
if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.
Time Frame
1 hour after caudal block.
Title
Postoperative Respiratory Depression
Description
if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.
Time Frame
2 hours after caudal block.
Title
Postoperative Respiratory Depression
Description
if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.
Time Frame
4 hours after caudal block.
Title
Postoperative Respiratory Depression
Description
if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.
Time Frame
6 hours after caudal block.
Title
Postoperative Respiratory Depression
Description
if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.
Time Frame
12 hours after caudal block.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Society of Anaesthesiologists (ASA) Status I and II Aged between 1 to 6 years Planned for below umbilicus elective surgery Exclusion Criteria: Refusal to consent by parent/guardian Injection site infection Coagulation disorders Congenital abnormalities of lower spine and meninges Anticipated difficult airway requiring endotracheal intubation and intermittent positive pressure ventilation Prone position surgical procedures Known drug allergy history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haris Chohan, FCPS Pakistan
Organizational Affiliation
Dr. Ruth KM Pfau Civil Hospital, Dow University of Health Sciences Karachi, Pakistan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Syed Farjad Sultan, FCARCSI, PhD
Organizational Affiliation
Dr. Ruth KM Pfau Civil Hospital, Dow University of Health Sciences Karachi, Pakistan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arun Kumar, FCPS
Organizational Affiliation
Dr. Ruth KM Pfau Civil Hospital, Dow University of Health Sciences, Karachi, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Haris Chohan
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75400
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Comparison of Doses of Dexmedetomidine With Bupivacaine in Caudal Block for Duration of Analgesia in Paediatric Infraumblical Surgeries.

We'll reach out to this number within 24 hrs