| CTRI Number |
CTRI/2021/10/037020 [Registered on: 01/10/2021] Trial Registered Prospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A CLINICAL TRAIL TO STUDY THE EFFECTIVENESS OF TWO PROCEDURES,SPINAL BLOCK AND PUDENDAL BLOCK IN HAEMORRHOIDS AND FISSURE IN ANO |
|
Scientific Title of Study
|
A RANDOMISED CONTROL TRIAL OF SPINAL BLOCK VS PUDENDAL BLOCK IN HAEMORRHOIDS AND FISSURE IN ANO |
| Trial Acronym |
RCTSPB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavankumar velagambeti |
| Designation |
Pg student |
| Affiliation |
SAGAR HOSPITALS |
| Address |
44,54,4th T-block east, General surgery department, Ground floor, Room no 9, Tilak Nagar main road, Bannerughatta approach road layout, Jayanagar
Bangalore
KARNATAKA
560041
India |
| Phone |
08790350665 |
| Fax |
|
| Email |
velagambetipavan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavankumar velagambeti |
| Designation |
Pg student |
| Affiliation |
SAGAR HOSPITALS |
| Address |
44,54,4th T-block east, General surgery department, Ground floor, Room no 9, Tilak Nagar main road, Bannerughatta approach road layout, Jayanagar
Bangalore
KARNATAKA
560041
India |
| Phone |
08790350665 |
| Fax |
|
| Email |
velagambetipavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavankumar velagambeti |
| Designation |
Pg student |
| Affiliation |
SAGAR HOSPITALS |
| Address |
44,54,4th T-block east, General surgery department, Ground floor, Room no 9, Tilak Nagar main road, Bannerughatta approach road layout, Jayanagar
Bangalore
KARNATAKA
560041
India |
| Phone |
08790350665 |
| Fax |
|
| Email |
velagambetipavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAGAR HOSPITALS, BANGALORE |
|
|
Primary Sponsor
|
| Name |
SAGAR HOSPITALS |
| Address |
44,54 Tilak nagar main road, Bannerughatta approach road layout, 4th T-block east, Tilak nagar,jayanagar |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrRavishankar |
Sagar Hospitals |
44,54 Tilak nagar main road, Bannerughatta approach road layout, 4th T-block east, Tilak nagar,jayanagar,General surgery department,ground floor,room no 9
Bangalore
KARNATAKA |
9902637360
ravishankarhr@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pudendal block |
1. Patients will receive pudendal block with 15 ml of 0.75 percent ropivacaine |
| Intervention |
Spinal block |
patient will receive 1.5ml 0.5 percent bupivacaine after identification of anatomical space |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1 Age: 18 years and above
2 Elective Perianal Surgeries
3 Hemorrhoids
4 Fissure in ano
|
|
| ExclusionCriteria |
| Details |
1 Patients unwilling to participate
2 Perianal abscess/ Skin lesions – active infection
3 Fistula in ano
4 Coagulopathies
5 Hypersensitivity to anaesthetic agents
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To compare the analgesic effect and comfort levels of pudendal block vs spinal block in Haemorrhoids and fissure in ano |
Aug 2021- Jun 2022
after completion of study(1year) data is interpret |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess early ambulation
• To assess complication profile of the surgery as well as the anaesthetic given
|
Aug 2021- Jun 2022
After completion of study around 1year data is interpret. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
03/10/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of the study is to identify which procedure (Spinal Block Vs Pudendal Block) provides better pain relief post operatively. Patient will be given anesthesia before surgery and will be monitored on how comfortable the patient both during and after the surgery. We will monitor pain and related complications if any. The type of anesthsia given will be based on the research protocol. It will be either an injection to the back or an injection in the area of the rectum. Patient identity and information obtained during this study will not be disclosed and participation in the study will remain confidential. |