| CTRI Number |
CTRI/2024/06/068724 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study effect of different height of operating table on level of comfort of anaesthetist and success rate while performing spinal anesthesia on patients . |
|
Scientific Title of Study
|
Impact of operating table ergonomics on anaesthesiologist comfort while performing subarachnoid block |
| 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 Mayuri Golhar |
| Designation |
Associate Professor |
| Affiliation |
Pt.BDS, P.G.I.M.S Rohtak |
| Address |
Department of Anesthesia, room no 29, first floor modular to complex, PT. B.D.Sharma, P.G.I.M.S, Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
9599912334 |
| Fax |
|
| Email |
drmayuriyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayuri Golhar |
| Designation |
Associate Professor |
| Affiliation |
Pt.BDS, P.G.I.M.S Rohtak |
| Address |
Department of Anesthesia, room no 29, first floor modular to complex, PT. B.D.Sharma, P.G.I.M.S, Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
9599912334 |
| Fax |
|
| Email |
drmayuriyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankur Taparia |
| Designation |
post graduate |
| Affiliation |
Pt. B.D.S. P.G.I.M.S, Rohtak |
| Address |
Department of Anesthesia,first floor modular to complex, PT. B.D.Sharma, P.G.I.M.S, Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
7988380252 |
| Fax |
|
| Email |
taparia48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Haryana, Director, Director office.Pandit Bhagwat Dayal Sharma Institute of Medical Science, P.G.I.M.S,Rohtak ,Haryana-124001 |
|
|
Primary Sponsor
|
| Name |
Director Post Graduate Institute of Medical Sciences |
| Address |
Director Office,
PGIMS Campus,
Rohtak Haryana-124001 |
| 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 Mayuri Golhar |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science |
Department of Anaesthesia, 2nd floor modular Ot Complex. Pt BDS, P.G.I.M.S, Rohtak.
Rohtak
HARYANA |
9599912334
drmayuriyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt, B.D.Sharma PGIMS/ UHS,Rohtak |
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 |
Group R( table level at lower rib margin) |
Patients included in the study will receive subarachnoid block at L3-L4 level in sitting position adjusting the operating table at level R (at the level of rib).The following will be measured at the time of performing the block
1.The angle of needle insertion(A) will noted. Successful block will be considered after CSF flow.
2.Number of attempts (N1,N2,N3) will be noted
3.Musculoskeletal discomfort of the Anaesthesiologist will be measured on NRS scale.
4.Degree of neck and thoracolumbar flexion will be noted on digital image. |
| Intervention |
Group U ( table level at umbilicus) |
Patients included in the study will receive subarachnoid block at L3-L4 level in sitting position adjusting the operating table at level of U( at umbilicus of anaesthesiologist).The following will be measured at the time of performing the block.
1.The angle of the needle insertion(A) will be measured after successfully reaching the subarachnoid space.Successful spinal block will be considered after CSF flow.
2.Number of attempts (N1,N2,N3) will noted.
3.Musculoskeletal discomfort of the Anaesthesiologist will be measured on NRS scale.
3. Degree of neck and thoracolumbar flexion of the Anaesthesiologist will be noted while performing the procedure on digital image. |
| Comparator Agent |
Group X( table at level of xiphoid process) |
Patients included in the study will receive subarachnoid block at L3-L4 level in sitting position adjusting the operating table at level X (at level of xiphoid process). The following will be measured at the time of performing the block
1.The angle of the needle insertion( A)will be measured after reaching the subarachnoid space of there patient. successful block will be considered after CSF flow
2.Number of attempts N1,N2,N3 will be noted.
3.Musculoskeletal discomfort of the Anaesthesiologist will be rated on NRS scale.
4. Degree of neck and thoracolumbar flexion of the Anaesthesiologist will be noted on digital image while performing the procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA(American society Anaesthesiologist)physical status I and II , of either sex of age group 18 to 60 years, scheduled to undergo surgery requiring spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
patients with bleeding tendency, spine disorders or deformity, drug allergy to local anaesthesia, pregnant females, patients not willing to participate will be excluded from the study |
|
|
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 optimal height of the operating table which increases the level of comfort of the anaesthesiologist. |
At the point of performing the subarchnoid block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the angle of entry of spinal needle at different operating table height.
2. To assess the number of redirection of spinal needle & success rate of block at different
Operating table height. |
At the time of performing the subarachnoid block. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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) |
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
|
Tiltle: Impact of operating table ergonomics on Anaesthesiologist comfort while performing subarachnoid block.Aim: to compare different height of operating table which increases the level of comfort of the anesthesiologist while performing spinal anesthesia. Primary objective: to assess the optimal height of operating table which increases the level of comfort of the anaesthesiologist. Secondary objective: 1. to assess the angle of entry of spinal needle at different table height. 2. to assess the number of redirection and success rate of block at different operating table height.
Inclusion criteria: patients of age group 18 to 60 years of physical status ASA I and II planned for surgery under spinal anaesthesia. Exclusion criteria: Patient not willing to participate, with BMI>30, pregnant females, contraindication to spinal anesthesia, bleeding diathesis , patients with spine deformity and difficult spine will be excluded
sample size: 90
group allocation: U- operating table at the level; of umbilicus of the anesthesiologist R- operating table at the level of rib X- operating table at the level of xiphoid process
Assessment: at the different operating table height 1) angle of spinal needle insertion 2) number of redirection required 3) successful block 4) musculoskeletal discomfort of the anesthesiologist and degree of neck flexion along will be noted Analysis- data will be complied and appropriate statistical analysis will be applied.
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