FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/09/021453 [Registered on: 30/09/2019] Trial Registered Prospectively
Last Modified On: 05/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Study of Epidural versus Combined Spinal Epidural Anaesthesia for Lower Abdomen and Leg Surgeries  
Scientific Title of Study   Study of Epidural versus Combined Spinal Epidural Anaesthesia for Lower Abdominal and Limb Surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bidyapati Padhan 
Designation  2nd Year PG Anaesthesia 
Affiliation  Veer Surendra Sai Institute Of Medical Science And Research 
Address  Dept. Of Anaesthesiology and critical care VSSIMSAR BURLA SAMBALPUR

Sambalpur
ORISSA
768017
India 
Phone  8658069089  
Fax    
Email  drbpadhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bimal Kishore Panda 
Designation  Associate Professor, Dept of Anaesthesiology and critical care,VSSIMSAR,BURLA 
Affiliation  Veer Surendra Sai Institute Of Medical Science And Research 
Address  Dept. Of Anaesthesiology and critical care VSSIMSAR BURLA SAMBALPUR

Sambalpur
ORISSA
768017
India 
Phone  9437175425  
Fax    
Email  drbimalpanda@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bimal Kishore Panda 
Designation  Associate Professor, Dept of Anaesthesiology and critical care,VSSIMSAR,BURLA 
Affiliation  Veer Surendra Sai Institute Of Medical Science And Research 
Address  Dept. Of Anaesthesiology and critical care VSSIMSAR BURLA SAMBALPUR

Sambalpur
ORISSA
768017
India 
Phone  9437175425  
Fax    
Email  drbimalpanda@gmail.com  
 
Source of Monetary or Material Support  
Veer Surendra Sai Institute Of Medical Science And Research AT/PO- BURLA,DIST- SAMBALPUR,STATE - ODISHA PIN-768017 
 
Primary Sponsor  
Name  Veer Surendra Sai Institute Of Medical Science And Research 
Address  Dept. Of Anaesthesiology and critical care VSSIMSAR BURLA SAMBALPUR 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bidyapati Padhan  Veer Surendra Sai Institute Of Medical Science And Research  Surgery operation theatre, Obstretic and guenic operation theatre, Orthopedics operation theatre
Sambalpur
ORISSA 		 8658069089

drbpadhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE,VEER SURENDRA SAI INSTITUTE 9F MEDICAL SCIENCE AND RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (2) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (3) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (4) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified, (5) ICD-10 Condition: D289||Benign neoplasm of female genitalorgan, unspecified, (6) ICD-10 Condition: S999||Unspecified injury of ankle and foot, (7) ICD-10 Condition: S899||Unspecified injury of lower leg, (8) ICD-10 Condition: S799||Unspecified injury of hip and thigh, (9) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (10) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (11) ICD-10 Condition: N819||Female genital prolapse, unspecified, (12) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (13) ICD-10 Condition: N949||Unspecified condition associated with female genital organs and menstrual cycle, (14) ICD-10 Condition: S799||Unspecified injury of hip and thigh, (15) ICD-10 Condition: C402||Malignant neoplasm of long bones of lower limb, (16) ICD-10 Condition: C403||Malignant neoplasm of short bonesof lower limb,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combined spinal epidural anaesthesia  Group C will receive combined spinal epidural anaesthesia- after placement of epidural catheter and confirmation with test dose 3 ml of lignocaine 2% and adrenaline1:2 lakh, 2.5ml of 0.5% Bupivacaine heavy injected intrathecally by 25 G quinckes needle in a separate space and patient placed in supine position. 1.5-2 ml of bupivacaine 0.5% per every unblocked segment injected into epidural space after 10 minutes. [2,3]  
Comparator Agent  Epidural anaesthesia  Group E will receive epidural anaesthesia – After proper aseptic measure a epidural catheter will be placed in epidural space by loss of resistance technique with 18 G touhy needle. after a test dose of 3 ml of lignocaine 2% and adrenaline 1:2 lakh,20 ml of 0.5% Bupivacaine will be injected into epidural space.1.5-2 ml of bupivacaine 0.5% per every unblocked segment will be injected into epidural space after the highest level of sensory block is achieved. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria(all)
1. ASA Grade I & II.
2. Age 20 to 60 years of both sex.
3. Undergoing lower limb and lower abdominal surgeries up to 2 hours.
 
 
ExclusionCriteria 
Details  exclusion criteria(none)
1. Infection at the site of injection
2. Spinal abnormalities
3. Neurological disorders
4. Coagulation disorders
5. Drug allergy 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
combined spinal epidural anaesthesia is better in term of onset, duration, efficacy, surgical analgesia, muscle relaxation and hemodynamic response over epidural anaesthesia alone.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Systemic toxicity,adverse effects if any.  Will be observed and recorded 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2019 
Date of Study Completion (India) 31/07/2020 
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 Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is to compare Combined spinal epidural anaesthesia versus epidural anaesthesia  in terms of Onset,duration,efficacy,surgical anaesthesia and haemodynamic response. 
Close