| CTRI Number |
CTRI/2017/12/010988 [Registered on: 27/12/2017] Trial Registered Prospectively |
| Last Modified On: |
27/12/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to compare an injection given in lower back with injections given in outer layer of abdomen
in children undergoing lower abdominal surgery for pain scores. |
|
Scientific Title of Study
|
A prospective randomized controlled trial comparing caudal epidural block, ultrasound guided illioinguinal/ iliohypogastric nerve blocks and ultrasound guided transversus Abdominis plane block in paediatric patients undergoing elective inguinal region surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anudeep jafra |
| Designation |
Assistant professor |
| Affiliation |
Post graduate Institute of medical education and research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Post graduate Institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888027699 |
| Fax |
|
| Email |
anu_gmch@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anudeep jafra |
| Designation |
Assistant professor |
| Affiliation |
Post graduate Institute of medical education and research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Post graduate Institute of medical education and research, Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888027699 |
| Fax |
|
| Email |
anu_gmch@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anudeep jafra |
| Designation |
Assistant professor |
| Affiliation |
Post graduate Institute of medical education and research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Post graduate Institute of medical education and research, Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888027699 |
| Fax |
|
| Email |
anu_gmch@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of medical education and research, chandigarh |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of medical education and research |
| Address |
Post Graduate Institute of Medical Education and Research, sector 12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anudeep Jafra |
Department of anaesthesia and intensive Care |
4th floor, Nehru hospital, Department of Anaesthesia and Intensive Care, Post graduate Institute of Medical Education and Resaerch, Chandigarh, India
Chandigarh
CHANDIGARH |
9888027699
anu_gmch@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| post graduate institute of medical education and research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Undergoing elective Inguinal region surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
caudal block |
Patient would be placed in the left lateral position. The sacral hiatus between the sacral cornu would be palpated. With 23‑G short needle sacral puncture would be made with the bevel toward the abdomen at a 45‑degree angle. When the sacrococcygeal ligament seemed to have been punctured, the needle would be tilted more toward the skin surface and inserted 2‑3‑mm deeper. Negative aspiration would confirm any inadvertent blood vessel or dural puncture. Confirming, 0.75ml/kg of 0.2% ropivacaine would be injected in 2ml aliquots after intermittent careful negative aspirations. |
| Comparator Agent |
ultrasound guided ilioinguinal/iliohypogastric nerve block |
Using 6-13 Hz ultrasound probe block will be performed keeping the probe cephalad to the anterior superior iliac (ASIS) crest parallel to the line joining umbilicus and ASIS. After visualisation of the IL/IH nerves between inferior oblique and transversus Abdominis muscles, using in plane technique, 22 G hypodermic needle will be introduced, tip of the needle would be followed and hydrodissection with saline would be done for confirmation and local anaesthetic (0.1ml/kg of 0.2% ropivacaine) will be injected such that it surrounds the nerves. |
| Intervention |
ultrasound guided transversus abdominins plane block |
TAP block has been used in paediatric patients for lower abdominal and inguinal region surgeries; it is an abdominal field block which provides analgesia from T10 to L1 segment.Ultrasound probe (6-13Hz) would be kept cephalad to the ASIS keeping the probe parallel to line joining umbilicus and ASIS, keeping the probe at the anterior axillary line level, using hypodermic needle 22G using in plane technique needle will be inserted till the tip of the needle reaches interface between inferior oblique and transversus Abdominis and hydrodissection will be done using saline after confirmation local anaesthetic (0.3ml/kg of 0.2% ropivacaine) will be injected. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
We would enroll American Society of Anesthesiologists physical status I–II patients scheduled for elective unilateral inguinal surgery (inguinal herniotomy, hydrocelectomy,orchidopexy). |
|
| ExclusionCriteria |
| Details |
Exclusion criteria will include regional block refusal, known amide local anesthetic drug allergy, history of seizures or neurological, neuromuscular, psychiatric or blood clotting disorders, a history of clinically important renal, hepatic, cardiac, or neurological conditions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary end point will be time to first rescue analgesia (paracetamol (PCM)). |
In PACU pain scoring would be done every 15 minutes during the first hour in PACU and every 30 minutes for the next 3 hours in until discharge from the hospital. Pain will be assessed using FLACC Behavioural Pain Scale and Baker-Wong Faces Scale. If pain scores more than 6 they will be treated with injection fentanyl 0.5 microgram /kg and if pain scores more than 3 (FLACC)/more than 4(Baker Wong faces) injection paracetamol will be given |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary parameters would be total intra operative fentanyl consumption, time in image acquisition and drug injection, total post operative PCM consumption, pain and sedation scores, total number of patients requiring rescue analgesia (PCM), incidence of post op nausea vomiting, parental satisfaction scores. |
During the intraoperative course Vital parameters including heart rate, blood pressure and saturation will be recorded every 1minute for first 5minutes after block placement, at the time of skin incision, 5, 10 and 15 mins later. In PACU pain scoring and sedation scoring would be done every 15 minutes during the first hour in PACU and every 30 minutes for the next 3 hours in until discharge from the hospital.Incidence of nausea vomiting in PACU and parental satisfaction scores after 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of study We hypothesize that ultrasound guided nerve block (TAP and IL/IH) will provide better post operative analgesia as compared to CEB for inguinal region surgeries in children. We would enroll American Society of Anesthesiologists physical status I–II patients aged between 6 months and 8 years scheduled for elective unilateral inguinal surgery (inguinal herniotomy, hydrocelectomy,orchidopexy). Written informed consent for study procedures will be obtained from all parents. Group C = caudal block group (receive 0.75ml/kg of 0.2% ropivacaine) Group T = usg guided TAP block group (receive 0.3ml/kg of 0.2% ropivacaine) Group I = usg guided IL/IH nerve block (receive 0.1ml/kg of 0.2% ropivacaine) All patients will receive standard general anaesthesia Block procedure- USG IL/IH nerve block- Using 6-13 Hz ultrasound probe block will be performed keeping the probe cephalad to the anterior superior iliac (ASIS) crest parallel to the line joining umbilicus and ASIS. After visualisation of the IL/IH nerves between inferior oblique and transversus Abdominis muscles, using in plane technique, 22 G hypodermic needle will be introduced, tip of the needle would be followed and hydrodissection with saline would be done for confirmation and local anaesthetic (0.1ml/kg of 0.2% ropivacaine) will be injected such that it surrounds the nerves. CEB Patient would be placed in the left lateral position. The sacral hiatus between the sacral cornu would be palpated. With 23�’G short needle sacral puncture would be made with the bevel toward the abdomen at a 45�’degree angle. When the sacrococcygeal ligament seemed to have been punctured, the needle would be tilted more toward the skin surface and inserted 2�’3�’mm deeper. Negative aspiration would confirm any inadvertent blood vessel or dural puncture. Confirming, 0.75ml/kg of 0.2% ropivacaine would be injected in 2ml aliquots after intermittent careful negative aspirations. USG TAP block Ultrasound probe (6-13Hz) would be kept cephalad to the ASIS keeping the probe parallel to line joining umbilicus and ASIS, keeping the probe at the anterior axillary line level, using hypodermic needle 22G using in plane technique needle will be inserted till the tip of the needle reaches interface between inferior oblique and transversus Abdominis and hydrodissection will be done using saline after confirmation local anaesthetic (0.3ml/kg of 0.2% ropivacaine) will be injected.
The primary end point will be time to first rescue analgesia (paracetamol (PCM)). Secondary parameters would be total intra operative fentanyl consumption, time in image acquisition and drug injection, total post operative PCM consumption, pain and sedation scores, total number of patients requiring rescue analgesia (PCM), incidence of post op nausea vomiting, parental satisfaction scores. |