| CTRI Number |
CTRI/2024/03/063604 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the pain relief by two modalities caudal epidural block and quadratus lumborum block in pediatric lower abdominal surgeries |
|
Scientific Title of Study
|
Ultrasound-guided quadratus lumborum block versus ultrasound-guided caudal epidural block for post-operative analgesia in children undergoing lower abdominal surgeries: A prospective randomized controlled study |
| 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 Keerthi |
| Designation |
Post graduation junior resident |
| Affiliation |
AIIMS Raipur |
| Address |
Seminar room, OT complex, B block, 4th floor, department of anaesthesiology, All india institute of medical sciences, G.E. Road, Tatibandh, Raipur, Chhattisgarh
492099
Raipur CHHATTISGARH 492099 India |
| Phone |
9566064825 |
| Fax |
|
| Email |
keerthigmc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mayank Kumar |
| Designation |
Associate professor |
| Affiliation |
AIIMS Raipur |
| Address |
Faculty room no. 3, A block, department of anaesthesiology, All india institute of medical sciences, Great eastern road, Tatibandh, Raipur, Chhattisgarh
492099
Raipur CHHATTISGARH 492099 India |
| Phone |
9971760416 |
| Fax |
|
| Email |
mayanksonupmch@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mayank Kumar |
| Designation |
Associate professor |
| Affiliation |
AIIMS Raipur |
| Address |
Faculty room no.3, A block, department of anaesthesiology, All india institute of medical sciences, Great eastern road, Tatibandh, Raipur, Chhattisgarh 492099
Raipur CHHATTISGARH 492099 India |
| Phone |
9971760416 |
| Fax |
|
| Email |
mayanksonupmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences, Raipur. |
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences Raipur |
| Address |
All india institute of medical sciences, Great eastern road, Tatibandh, Raipur, Chhattisgarh 492099 |
| 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 Keerthi |
All India Institute of Medical Sciences, Raipur. |
Office Room Anaesthesia, B block OT complex,4th floor, AIIMS Raipur, Tatibandh, Chhattisgarh 492099 Raipur CHHATTISGARH |
9566064825
keerthigmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: K929||Disease of digestive system, unspecified, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (4) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (5) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound-guided caudal epidural block |
Route of administration: epidural injection.
Drug: 0.25% bupivacaine.
Dose: 1ml/kg
Time: 15 mins before the start of surgery |
| Intervention |
Ultrasound-guided quadratus lumborum block |
Route of administration: fascial plane between the quadratus lumborum muscle and psoas major muscle. Drug: 0.25% bupivacaine. Dose: 0.5ml/kg. Time: 15 mins before the start of surgery. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children of ASA 1 and 2 undergoing lower abdominal surgery |
|
| ExclusionCriteria |
| Details |
Patients parents refusal
Patients with any contraindications to regional anesthesia
History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
History of allergic reaction to local anesthetic
Rash or skin infection at the site of injection
Anatomical abnormalities
Bleeding diathesis
Coagulation disorder
History of renal, hepatic, cardiac disorder, upper or lower airway infection or any neurological abnormalities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the postoperative pain intensity by FLACC scale |
At baseline, 1 hr, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 12 hrs and 24 hrs post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time to first post-operative rescue analgesic requirement
2.Total dose of paracetamol requirement post-operatively
3.Any adverse effects like hypotension, bradycardia, respiratory depression
|
At baseline, 1 hr, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 12 hrs & 24 hrs post-operatively |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| Date of Study Completion (India) |
04/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/03/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Lower abdominal surgeries are commonly done in pediatric group of patients and are associated with severe postoperative pain. Adequate analgesia during the perioperative period is vital to reduce the stress response to surgery and perioperative morbidity and to hasten the recovery.
For effective perioperative analgesia, regional anesthetic methods can be used along with other analgesics. One of the most often used methods of regional anesthesia in children is caudal epidural block, which provides efficient postoperative analgesia for sub-umbilical interventions.
Regional anesthesia in pediatrics has undergone a radical change as a result of the use of ultrasonography (US)-guided nerve blocks. Both upper and lower abdominal procedures using many truncal blocks have a good success rate. For infra-umbilical procedures, nerve blockade has been demonstrated to be just as successful as caudal block.
A recently discovered block called the quadratus lumborum block (QLB) uses ultrasound to successfully deliver secure and long-lasting analgesia. It is a fascial plane block that is becoming more and more common for pain control after lower abdominal surgeries. By using ultrasonography (US) to image the abdominal muscles as a guide, it is carried out with a local anesthetic injection between the Quadratus lumborum muscle and Psoas major muscle, and it is anticipated that analgesia will be provided from the level of the T7-L1 dermatome segment.
Justification:
Caudal block provides adequate analgesia during the intraoperative and early post-operative stages with more effective and consistent results. However it is associated with adverse effects and complications.
For somatic analgesia of both the upper and lower abdomen, the QL block is a novel abdominal truncal block. The QL block provides an excellent analgesic effect, with patients reporting a reduction in pain of 1-2/10 on the pain scale. According to observations, QL block led to shorter hospital stays and lower postoperative pain scores.
Very few studies have been done comparing Quadratus lumborum block and caudal block for lower abdominal surgeries in pediatric patients, hence we propose to carry out a Prospective Randomised Controlled Trial to compare the effectiveness of caudal epidural block against ultrasound-guided quadratus lumborum block as a postoperative analgesic in pediatric lower abdominal procedures. |