| CTRI Number |
CTRI/2026/01/102070 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find out which nerve block provides better pain relief in children undergoing surgery in the lower part of abdomen. |
|
Scientific Title of Study
|
A prospective randomized controlled trial comparing the analgesic efficacy of lateral vs posterior quadratus lumborum block in pediatric patients undergoing unilateral lower abdominal surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. GEETA KAMAL |
| Designation |
Senior Specialist, Head of Department |
| Affiliation |
Chacha Nehru Bal Chikitsalaya |
| Address |
Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
New Delhi
Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
New Delhi
New Delhi
DELHI
110031
India |
| Phone |
9643308229 |
| Fax |
|
| Email |
kmlgeeta@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. GEETA KAMAL |
| Designation |
Senior Specialist, Head of Department |
| Affiliation |
Chacha Nehru Bal Chikitsalaya |
| Address |
Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
New Delhi
Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
New Delhi
New Delhi
DELHI
110031
India |
| Phone |
09643308229 |
| Fax |
|
| Email |
kmlgeeta@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. GEETA KAMAL |
| Designation |
Senior Specialist, Head of Department |
| Affiliation |
Chacha Nehru Bal Chikitsalaya |
| Address |
Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
New Delhi
Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
New Delhi
New Delhi
DELHI
110031
India |
| Phone |
09643308229 |
| Fax |
|
| Email |
kmlgeeta@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr GEETA KAMAL |
| Address |
Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr AIKTA GUPTA |
senior specialist,Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
New Delhi |
| Dr NIDHI SINGH |
assistant professor,
Department of Anesthesia,
Chacha Nehru Bal Chikitsalaya
Geeta Colony
New Delhi |
| Dr SHAMEEMA ROOSHI |
FNB resident, Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Geeta Kamal |
Chacha Nehru Bal Chikitsalya |
Room number 203,2nd floor ward block,Department of Anesthesia,CNBC,
Geeta colony,
East Delhi
New Delhi
110031
East
DELHI |
9643308229
geetakml6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHACHA NEHRU BAL CHIKTSALAYA INSTITUITIONAL ETHIC COMMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (3) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lateral QLB |
USG guided lateral QLB administered after standard anesthesia induction protocols.0.2% Ropivacaine with dexmedetomidine will be given in the block. Duration from the time of administering the drug to the time when patient complains of pain will be the duration of analgesia.Pateint will be monitored for pain for 24 hours after the surgery.If the pain score is more than 4, rescue analgesics will be given. |
| Comparator Agent |
Posterior QLB |
USG guided Posterior QLB administered after standard anesthesia induction protocols.0.2% Ropivacaine with dexmedetomidine will be given in the block. Duration from the time of administering the drug to the time when patient complains of pain will be the duration of analgesia.Pateint will be monitored for pain for 24 hours after the surgery.If the pain score is more than 4, rescue analgesics will be given. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA1 and ASA2 patients of 6months to 8 years age posted for unilateral infraumbilical surgeries who consent regional anesthesia |
|
| ExclusionCriteria |
| Details |
patient with known allergy to study drugs
infection at the procedure site
daycare surgeries |
|
|
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 |
| Time to rescue analgesia demand in the postoperative period.Time interval between the end of local anesthetic injection till the patient complaining of Face Leg Activity Cry Consolability Score more than 4. |
0min, 15 min, 30min, 1 hr,2hr, 6hr, 12hr,18hr, and 24hr after the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Face Leg Activity Cry Consolability Score after shifting to post anesthesia care unit, 15 minutes,30 minutes, 1 hour and in the ward every 6 hourly till 24 hour after the surgery. |
Face Leg Activity Cry Consolability Score after shifting to post anesthesia care unit, 15 minutes,30 minutes, 1 hour and in the ward every 6 hourly till 24 hour after the surgery. |
| Total analgesic consumption postoperatively |
|
| perioperative adverse events hypotension and bradycardia |
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
09/02/2026 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective randomized controlled double blinded trial aims to compare the analgesic efficacy and safety of lateral versus posterior quadratus lumborum block in children undergoing unilateral lower abdominal surgery. A total of 120 children between 6 months to 8 years of ASA1 and ASA2 scheduled for unilateral infraumbilical surgery will be enrolled and randomized equally into two groups, group L and group P. Group allocation will be done based on Sequentially numbered opaque sealed envelope method. Both groups will receive 0.5ml per kg of 0.2% Ropivacaine and 0.5 mcg per kg of Dexmedetomidine during the block administration. Blocks will be performed by one of the investigators following standardized anesthesia induction protocols. The primary outcome is duration of analgesia, which will be compared between the two groups. Study will be started after CTRI registration approval. |