| CTRI Number |
CTRI/2018/05/013866 [Registered on: 14/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study of Pudendal Nerve Block ( Inferior Rectal Branch) for Post - Haemorrhoidectomy Pain |
|
Scientific Title of Study
|
Comparison of the Post- Operative Analgesia in Haemorrhoidectomy patients after Peripheral Block using DEXMEDETOMIDINE VS CLONIDINE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhu Velayudhen |
| Designation |
Associate Professor |
| Affiliation |
Sree Gokulam Medical College And Research Foundation |
| Address |
Associate Professor
Department Of Anaesthesiology
Sree Gokulam Medical College And Research Foundation
Venjaramoodu
Trivandrum
Thiruvananthapuram
KERALA
695607
India |
| Phone |
04723041000 |
| Fax |
|
| Email |
madhuvelayuden@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar Sudevan |
| Designation |
Senior Resident |
| Affiliation |
Sree Gokulam Medical College And Research Foundation |
| Address |
Department Of Anaesthesiology
Sree Gokulam Medical College And Research Foundation
Venjaramoodu
Trivandrum
Thiruvananthapuram
KERALA
695607
India |
| Phone |
04723041000 |
| Fax |
|
| Email |
vinodsudevan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu Velayudhen |
| Designation |
Associate Professor |
| Affiliation |
Sree Gokulam Medical College And Research Foundation |
| Address |
Associate Professor
Department Of Anaesthesiology
Sree Gokulam Medical College And Research Foundation
Venjaramoodu
Trivandrum
Thiruvananthapuram
KERALA
695607
India |
| Phone |
04723041000 |
| Fax |
|
| Email |
madhuvelayuden@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Gokulam Medical College And Research Foundation |
|
|
Primary Sponsor
|
| Name |
Sree Gokulam Medical College And Research Foundation |
| Address |
Department Of Anaesthesiology
Sree Gokulam Medical College And Research Foundation
Venjaramoodu- 695607
|
| Type of Sponsor |
Private 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 Madhu Velayudhen |
Sree Gokulam Medical College And Research Foundation |
Department Of Anaesthesiology
Sree Gokulam Medical College And Research Foundation
Venjaramoodu- 695607
Thiruvananthapuram
KERALA |
9400369133
madhuvelayuden@gmail.com |
|
|
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 |
Post Haemorrhoidectomy Pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonidine |
Pudendal block with 20 ml of 0.25% Bupivacaine with Clonidine 1 mcg/kg as additive |
| Intervention |
Dexmedetomidine |
Pudendal block with 20 ml of 0.25% Bupivacaine with Dexmedetomidine 1 mcg/kg as additive. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
BMI<30
Normal coagulation parameters and platelet count(>100000)
No systemic infection
|
|
| ExclusionCriteria |
| Details |
BMI>30
Severe liver renal or cardiac disease
Allergy or contraindications to any of the study drugs
Previous surgery in the anal canal
Pain or chronic analgesic administration in the preoperative period
Abnormal coagulation parameters and platelet count(<100000)
Systemic infection
Patient requesting general anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of post-operative analgesia |
Post operative monitoring for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative haemodynamic stability |
1,5,10,30,60,120,180,240,360,480,600,720 min after completion of injection |
| Sedation |
Every 30 minutes for 24 hours during the postoperative period |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/10/2014 |
| Date of Study Completion (India) |
24/03/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A study was conducted to compare the duration of post-operative analgesia in patients undergoing haemorrhoidectomy who are given pudendal nerve block with either Clonidine or Dexmedetomidine alongwith local anaesthetic Bupivacaine in the operation theatre of Sree Gokulam Medical College and Research Foundation, Venjaramoodu, Trivandrum, Kerala.
60 patients were randomly divided into two groups of 30 each -- group C underwent pudendal block with 20ml of 0.25% Bupivacaine with Clonidine 1mcg / kg as additive and group D underwent pudendal block with 20ml of 0.25% Bupivacaine with Dexmedetomidine 1mcg/kg as additive .
Complications like sedation, bradycardia and hypotension were also studied.
The data was entered in excel and analysed using SPSS 20.0 and compared using t test and chi square test.
There was significant difference in the duration of post-operative analgesia between the two groups.
The duration of analgesia in group C was 761 +/_ 19.1 minutes while in group D it was 1184.57 +/_ 151.374 minutes.
In pudendal nerve block, addition of Dexmeditomidine as an adjuvant to 0.25% Bupivacaine prolongs the duration of post-operative analgesia and is not associated with any major side effects.
Both drugs have an added advantage of conscious sedation and haemodynamic stability, making them potential adjuvants for nerve blocks.
|