| CTRI Number |
CTRI/2025/12/098746 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Obsevational study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study Evaluating the Outcome of Anterior Quadratus Lumborum Block as an Analgesic Intervention among participants Undergoing Open Reduction and Internal Fixation for Acetabular Fracture under Spinal Anesthesia |
|
Scientific Title of Study
|
An Observational study of Anterior Quadratus Lumborum Block in ease of positioning for spinal anesthesia among fracture acetabulum cases at SMS Medical College, Jaipur. |
| 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 Vandana Mangal |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College, Jaipur |
| Address |
Department of Anesthesiology, Second floor, Dhanwantri Building JLN Marg ,Jaipur, Rajasthan, India Department of Anesthesiology , Dhanwantri Building JLN Marg ,Jaipur, Rajasthan, India Jaipur RAJASTHAN 302001 India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vandana Mangal |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College, Jaipur |
| Address |
Department of Anesthesioloy, Second floor, Dhanwantri Building JLN Marg ,Jaipur, Rajasthan, India Department of Anesthesiology Dhanwantri Building JLN Marg ,Jaipur, Rajasthan, India Jaipur RAJASTHAN 302001 India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kiran Goyal |
| Designation |
Pg Student |
| Affiliation |
Sawai Man Singh Medical College, Jaipur |
| Address |
Department of Anesthesia, Second floor, Dhanwantri building JLN Marg ,Jaipur, Rajasthan, India 274, Gurunankpura Tilak nagar,Raja park ,Jaipur, Rajasthan, India Jaipur RAJASTHAN 302001 India |
| Phone |
9521013574 |
| Fax |
|
| Email |
Kirangoyal1769@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,second floor Dhanwantri building,JLN Marg, , Jaipur,Rajasthan 302001 India |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anesthesia ,Second floor , Dhanwantri building, SMS Medical College, Jaipur,Rajasthan 302001 India |
| Type of Sponsor |
Government medical college |
|
|
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 Vandana Mangal |
SMS Medical college and Hospital , Jaipur |
Department of Anesthesia Second Floor Dhanvantri Building SMS Hospital, Jaipur Jaipur RAJASTHAN |
9829056816
vandanamangal25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF ETHICS COMMITTEE, S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITAL, JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Patients undergoing open reduction and internal fixation for fracture acetabulum
• In age group of 18-65 years of both sexes.
• Patients belonging to American Society of Anaesthesiologists (ASA) class I, II and III.
• Patients giving consent for participation.
|
|
| ExclusionCriteria |
| Details |
• Patient should not be a part of any other study.
• Patients allergic to local anaesthetic(Ropivacaine)
• Local pathology at the injection site.
• Patients with neurological, psychiatric, neuromuscular disease or patient not able to tell block assessment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare difference in NRS from baseline , 5 min , 30 min after the block.
2. To assess and compare Mean Time taken 5 min to 30 min achieve NRS less then 2 for assessing sitting position for spinal anesthesia.
3. To assess and compare the difference in sitting angle before the block and at positioning for spinal anesthesia.(NRS less then 2)
4. To assess good positioning for CSE anesthesia in terms of number of pricks for successful lumbar puncture
|
1. To assess and compare difference in NRS from baseline at 5 min ,10min ,15 min,20 min, 25 min, 30 min after the block.
2. To assess and compare Mean Time taken 5min to 30 min achieve NRS less then 2 for assessing sitting position for spinal anesthesia.
3. To assess and compare the difference in sitting angle before the block and at positioning for spinal anesthesia.(NRS less then 2)
4. To assess good positioning for CSE anesthesia in terms of number of pricks for successful lumbar puncture
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess post-operative analgesia at 6,12,18,24 hours in cases of spinal anesthesia.
|
post operative analgesia at 6,12,18,24 hours |
|
|
Target Sample Size
|
Total Sample Size="33" Sample Size from India="33"
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)
|
20/12/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Acetabulum fractures although constitute only 1.5 -3% of geriatric orthopaedic trauma but are on the rise. A large proportion of them are elderly with multiple comorbidities and their associated challenges. It is a painful condition both at rest and on slight movement. good perioperative analgesia is mandatory for these patients, like in any other orthopaedic trauma. Many recipes have been tried for perioperative pain relief ranging from systemic analgesia with or without opioids to multimodal analgesia. Many regional blocks like femoral nerve block, 3 in 1, fascia ilaca, supra inguinal fascia ilaca and peri capsular nerve group block have been tried as part of multimodal analgesia. These days acetabulum fractures are fixed surgically, anaesthesia of choice for these patients is central neuraxial block and many times combined spinal epidural for both long duration surgeries and postoperative analgesia. For these blocks sitting position is preferable as patients find it difficult to lie on the side. To perform these blocks successfully in one go the patient has to be pain free and comfortable. Systemic analgesia is a choice, but at times it does not offer adequate analgesia and patient sometimes feel a little dizzy if they are given opioids. So we all look forward to good regional blocks for effective analgesia during positioning these patients for central neuraxial blocks. Blanco introduced the Quadratus Lumborum block in 2007 and it is now emerging as new regional block that has performed favourably in lower abdominal surgery and is being evaluated for hip analgesia. It is believed to provide pain relief for patients with hip fractures because it has multiple approaches. Cadaveric studies of the QLB showed direct dye spread to the roots and branches of the lumbar plexus; thus, these studies supported the possible benefit of QLB in hip surgeries. However, the anterior approach is being tried because the posterior and lateral approaches are not possible for these patients. The drug is deposited between the quadratus lumborum and the psoas muscle in this block, where it seeps up to the lumbar plexus. Therefore, we wish to assess the effectiveness of analgesia of anterior quadratus lumborum block for positioning patients with fracture acetabulum for spinal anesthesia. |