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CTRI Number  CTRI/2015/04/005731 [Registered on: 29/04/2015] Trial Registered Retrospectively
Last Modified On: 17/04/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Regional nerve block Buccal Mucosal Graft  
Scientific Title of Study   Efficacy of Infra orbital nerve block in BMG urethroplasty. 
Trial Acronym  IOB-BMG 
Secondary IDs if Any  
Secondary ID  Identifier 
EC / NIMS / 1462 /2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nirmala Jonnavithula 
Designation  Additional professor 
Affiliation  Dept. of Anesthesiology and Intensive care. Nizams Institute of Medical Sciences 
Address  Dept. Of Anesthesiology and Intensive care Nizams Institute of Medical Sciences Panjagutta Hyderabad 82
Dept. Of Anesthesiology and Intensive care Nizams Institute of Medical Sciences Panjagutta Hyderabad 82
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9849422749  
Fax  9849422749  
Email  njonnavithula@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepak Bachu 
Designation  resident  
Affiliation  Resident Dept Of Urology and Renal transplantation 
Address  Dept. Of Urology and Renal transplantation Nizams Institute of Medical Sciences Panjagutta Hyderabad 82
Dept Of Urology and Renal transplantation Nizams Institute of Medical Sciences Panjagutta Hyderabad 82
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9848626251  
Fax  9848626251  
Email  bachudeepakk@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Nirmala Jonnavithula 
Designation  Additional professor 
Affiliation  Dept. of Anesthesiology and Intensive care. Nizams Institute of Medical Sciences 
Address  Dept. Of Anesthesiology and Intensive care Nizams Institute of Medical Sciences Panjagutta Hyderabad 82
Dept. Of Anesthesiology and Intensive care Nizams Institute of Medical Sciences Panjagutta Hyderabad 82
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9849422749  
Fax  9849422749  
Email  njonnavithula@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  nil 
Address  NA 
Type of Sponsor  Other [nil] 
 
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 Nirmala  operation theater 3 and ward 9  Dept. Of Anesthesiology and Intensive care and Dept. of Urology and Renal Transplantation Nizams Institute of Medical Sciences Panjagutta Hyderabad 82
Hyderabad
ANDHRA PRADESH 		 9849422749

njonnavithula@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  stricture urethra,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  epidural anangesia and urethroplasty  Epidural analgesia was with continuous infusion of 0.25% bupivacaine and 1:1 ratio fentanyl Dose titrated to the need of the patientpostoperative analgesia 
Intervention  infraorbital block  infraorbital block was given with 1mlof 0.5% bupivacaine at infraorbital foramen by intra oral approach. It was given twice first before harvesting the buccal mucosal graft and second tme at the end of the procedure to avoid surgical duration bias. pain and mmorbidity was followed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  All patients with stricture urethra for BMG urethroplasty
Age 18-60
ASA I and II
 
 
ExclusionCriteria 
Details  Exclusion Criteria:
Patients with local infection at the site of injection of nerve block

history suggestive of drug allergy,

any systemic disease that compromise any cardiovascular, respiratory and neurological function,

coagulation disorders,

visible submucosal fibrotic changes of buccal mucosa
.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain at the donor site of buccal mucosa
Time to take oral diet both liquid and solids
Long term morbidity at 1 month
tightness in mouth opening
dribbling of saliva
numbness
patient satisfaction
 		 pain scores at every 4hhrs and time to oral liquid and solids every 24hrs and after 30 daysnsatisfaction and long term morbidity morbidity
 
 
Secondary Outcome  
Outcome  TimePoints 
patient satisfaction  one month 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   10/11/2013 
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)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The primary purpose of the study was to

evaluate the efficacy of infraorbital nerve block (IOB)in relieving pain at the donor site of the buccal mucosal graft and its assosciated morbidity.

 

Methods :  28 adults scheduled for buccal mucosal graft urethroplasty were enrolled in this study were  randomized into two groups by computer generated random numbers. All patients received standard general anesthesia with nasotracheal intubation. All patients received epidural analgesia with 0.25% bupivacaine intra and postoperatively for 48hrs.

Group- I (14 pts) received no IOB and is the control. Group –II (14pts) received block intra-orally twice with 1ml of 0.5% bupivacaine one after intubation and second after completion of surgery to avoid bias of surgical duration and is the study group.  Pain was assessed by visual analogue score,  intra oral morbidity, patient satisfaction, chronic oral pain were  noted in two groups. If the pain score exceeded 4 rescue analgesia inj tramadol was administered intramuscularly. All Patients were followed up after 1 and  6 months for chronic morbidity like perioral numbness and tightness on opening mouth and any other problems if any.

 

 

 

 

 
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