| CTRI Number |
CTRI/2024/11/077029 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Spinal anesthesia method for surgery: landmark vs ultrasound guided |
|
Scientific Title of Study
|
Comparison of efficacy of ultrasound guided and conventional landmark technique in patients with difficult spine predictors for spinal anesthesia: open RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmitha |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bibi Nagar |
| Address |
Department of Anesthesiology
All India Institute of Medical Sciences, Bibi Nagar, Hyderabad Metropolitan Region, Telangana
Nalgonda TELANGANA 508126 India |
| Phone |
9449554515 |
| Fax |
|
| Email |
sushmithaa1994@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ayya Syama Sundar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibi Nagar |
| Address |
Department of Anesthesiology
All India Institute of Medical Sciences, Bibi Nagar, Hyderabad Metropolitan Region, Telangana
Nalgonda TELANGANA 508126 India |
| Phone |
8179309677 |
| Fax |
|
| Email |
sasyasyama@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ayya Syama Sundar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibi Nagar |
| Address |
Department of Anesthesiology
All India Institute of Medical Sciences, Bibi Nagar, Hyderabad Metropolitan Region, Telangana
Nalgonda TELANGANA 508126 India |
| Phone |
8179309677 |
| Fax |
|
| Email |
sasyasyama@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bibi Nagar, Hyderabad Metropolitan Region
Telangana-508126
Hyderabad
India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical SciencesBibinagar |
| Address |
All India Institute Of Medical Sciences
Bibi Nagar
Hyderabad Metropolitan Region
Telangana
508126
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 Ayya Syama Sundar |
All India Institute of Medical Sciences, Bibi Nagar |
Room number G35 and G36
Operation Theater Complex
Department of Anesthesiology
All India Institute of Medical sciences, Bibi Nagar
Hyderabad Metropolitan Region Nalgonda TELANGANA |
8179309677
sasyasyama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(AIIMS BBN-IEC) |
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 |
| Comparator Agent |
Landmark technique of spinal anesthesia |
In the conventional landmark group, patients with difficult spinal predictors, iliac crests, spinous process and interspinous gaps will be palpated to determine the midline and the target intervertebral space.
The marking will be done in the OT 5 minutes before surgery and proceeded onto spinal anesthesia. |
| Intervention |
Ultrasound guidance for visualization of subarachnoid space |
In patients with difficult spinal predictors in the ultrasound group, imaging of the lumbar spine will be done to obtain the midline and transverse interlaminar view. The intersection of these two markings will guide the midline approach during the spinal anesthesia procedure.
The marking will be done in the OT 5 minutes before surgery and proceeded onto spinal anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with difficult spinal predictors
Elective surgery requiring Spinal Anesthesia
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients with severe cardiopulmonary diseases
contraindications of spinal anesthesia
inability to communicate/co-operate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the first attempt success rate between the two groups |
Within 5 minutes after completion of the procedure. There is only one time point as no serial measurements will be taken. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of needle redirections
2.Number of attempts (including number of redirections & new needle insertions).
3.Spinal puncture point Recognition time
a. Time from operator contact with the patient’s skin to marking the puncture site on the skin–for landmark technique.
b. Time from placing the probe on the skin to marking the puncture site—for Ultrasound assisted technique.
4.Needling time—time from local anesthetic infiltration to CSF flow
5.Total procedural time—recognition time plus needling time
6.Number of persons attempted |
Within 5 minutes after completion of the procedure. There is only one time point as no serial measurements will be taken. |
|
|
Target Sample Size
|
Total Sample Size="170" Sample Size from India="170"
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)
|
30/11/2024 |
| 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="0" 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
|
Neuraxial procedures are traditionally blind techniques where space is identified by palpation of anatomic landmarks namely iliac crests and spinous processes together with tactile feedback during needle insertion and loss of resistance confirming entry into subarachnoid space. But the technical difficulty of neuraxial blockade correlates with the quality of palpable surface landmarks. Palpation is often inaccurate and these surface landmarks may be absent, indistinct or distorted in many adult patients because of obesity, previous spinal surgery, deformity or degenerative changes of aging, insufficient gap between the spinal vertebrae, skin distances from the subarachnoid space, size of the needles; therefore, failed blocks and complications are common. Repeated attempts and redirections of the needle may lead to nerve injury, spinal hematoma, post dural puncture headache and added discomfort to the patient. Multiple case reports demonstrate the utility of ultrasound in guiding neuraxial blockade in patients with difficult spinal anatomy. Ultrasound imaging provides information about the accurate intervertebral level of puncture, optimal needle insertion point and depth of needle advancement for a successful neuraxial block. But there has been only few RCTs in the Indian scenario on the subject. Therefore, we designed a study aimed to compare the efficacy between the preprocedural ultrasound assisted technique and the conventional landmark based technique in patients with predictors of difficult spinal posted for elective surgery under spinal anesthesia. |