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CTRI Number  CTRI/2022/08/044889 [Registered on: 24/08/2022] Trial Registered Prospectively
Last Modified On: 10/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Infra-Alveolar Nerve Block Plus Buccal Nerve Block Vs Local Infiltration on Post-Operative Pain Scores at Buccal Mucosal Graft Harvest Site  
Scientific Title of Study   Effect Of Infraalveolar Nerve Block Plus Buccal Nerve Block Plus Local Infiltration Vs Local Infiltration on Post-Operative Pain Scores at Buccal Mucosal Graft Harvest Site: A Prospective Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swarnendu Mandal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Urology, 2nd Floor, OPD Block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha. Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  8297748337  
Fax    
Email  urol_swarnendu@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Swarnendu Mandal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Urology, 2nd Floor, OPD Block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha. Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  8297748337  
Fax    
Email  urol_swarnendu@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Swarnendu Mandal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Urology, 2nd Floor, OPD Block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha. Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  8297748337  
Fax    
Email  urol_swarnendu@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bhubaneswar 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of Urology, 2nd Floor, OPD Block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha. Khordha ORISSA 751019 India 
Type of Sponsor  Research institution and hospital 
 
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 Swarnendu Mandal  All India Institute of Medical Sciences, Bhubaneswar  Department of Urology, 2nd Floor, OPD Block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha.
Khordha
ORISSA 		 8297748337

urol_swarnendu@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N359||Urethral stricture, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Patients shall be given buccal nerve and infraalveolar nerve block with a mixture of 5 cc of 1% xylocaine, 5 cc of 25% bupivacaine, and 4 mg of dexamethasone. Then, hydrodissection over area of interest with 1:1 combination of 2% lignocaine and epinephrine (1:100.000) before undergoing BMG harvest.  Nerve block- mixture of 5 cc of 1% xylocaine, 5 cc of 25% bupivacaine, and 4 mg of dexamethasone. TOTAL 4 ML lOCAL INFILTRATION- 1:1 combination of 2% lignocaine and epinephrine (1:100.000); TOTAL 5 ML 
Comparator Agent  Patients shall undergo BMG harvest after hydrodissection over area of interest with 1:1 combination of 2% lignocaine and epinephrine (1:100,000). 5 cc shall be infiltrated  lOCAL INFILTRATION- 1:1 combination of 2% lignocaine and epinephrine (1:100.000); TOTAL 5 ML 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged 18 years or above undergoing Buccal Mucosal Graft harvest for any indication. 
 
ExclusionCriteria 
Details  1. Patients not giving consent
2. Patients with oral sub mucosal fibrosis
3. Active smokers
4. Patients with known drug allergy to local anesthetic drugs
5. Patients with severe cardiovascular compromise
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare postoperative pain scores amongst patients undergoing buccal mucosal graft harvest under infraalveolar plus buccal nerve block plus local infiltration vs local infiltration.  immediate post-operative period, 2 hrs, 4 hrs, 6 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 5 dats, 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
a) To compare time to resumption of pain free oral liquid intake amongst patients undergoing buccal mucosal graft harvest under infraalveolar plus buccal nerve block plus local infiltration vs local infiltration  immediate post-operative period, 2 hrs, 4 hrs, 6 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 5 dats, 7 days 
b) To compare time to resumption of pain free oral solid intake amongst patients undergoing buccal mucosal graft harvest under infraalveolar plus buccal nerve block plus local infiltration vs local infiltration  immediate post-operative period, 2 hrs, 4 hrs, 6 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 5 dats, 7 days 
c) To compare the incidence of postoperative complications: oral numbness, scarring, contracture, dry mouth at 1 month follow-up amongst patients undergoing buccal mucosal graft harvest under infraalveolar plus buccal nerve block plus local infiltration vs local infiltration  immediate post-operative period, 2 hrs, 4 hrs, 6 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 5 dats, 7 days 
d) To assess correlation between size of BMG harvested and post operative pain.  On the day of surgery 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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   Phase 3 
Date of First Enrollment (India)   05/09/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vivektarigopula@gmail.com].

  6. For how long will this data be available start date provided 26-04-2024 and end date provided 26-04-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Buccal Mucosal Graft (BMG) is the most common and versatile graft used for various techniques of urological reconstructions. Donor site morbidities have been studied previously. (1)Important morbidity of this procedure is post operative pain at the harvest site. Significant post operative pain often hinders resumption of normal oral diet.(2) Various strategies to alleviate pain like infiltration of donor site with various types of local anaesthetics and primary closure of the donor wound have been tried.(3) Primary closure of wound was found to be inferior to keeping the wound open in terms of post operative pain. (4,5)One study found infraorbital nerve block to be superior to no block. (6)The combined infraalveolar and buccal nerve block, which is commonly used in lower jaw dental procedures covers the area of interest of BMG, but has not been studied in this setting to our knowledge. We aim to compare its efficacy with respect to the current standard of care (SOC) of local anaesthetic infiltration. If significant improvement is detected as hypothesized, the usage of nerve blocks during BMG harvest might become the new standard of care.

References:

1.         Markiewicz MR, DeSantis JL, Margarone JE, Pogrel MA, Chuang SK. Morbidity Associated With Oral Mucosa Harvest for Urological Reconstruction: An Overview. Journal of Oral and Maxillofacial Surgery. 2008 Apr;66(4):739–44.

2.         Wood DN, Allen SE, Andrich DE, Greenwell TJ, Mundy AR. The morbidity of buccal mucosal graft harvest for urethroplasty and the effect of nonclosure of the graft harvest site on postoperative pain. J Urol. 2004 Aug;172(2):580–3.

3.         Chua ME, Zuckerman JM, Strehlow R, Virasoro R, DeLong JM, Tonkin J, et al. Liposomal Bupivacaine Local Infiltration for Buccal Mucosal Graft Harvest Site Pain Control: A Single-blinded Randomized Controlled Trial. Urology. 2020 Nov;145:269–74.

4.         Rourke K, McKinny S, St Martin B. Effect of wound closure on buccal mucosal graft harvest site morbidity: results of a randomized prospective trial. Urology. 2012 Feb;79(2):443–7.

5.         Soave A, Dahlem R, Pinnschmidt HO, Rink M, Langetepe J, Engel O, et al. Substitution Urethroplasty with Closure Versus Nonclosure of the Buccal Mucosa Graft Harvest Site: A Randomized Controlled Trial with a Detailed Analysis of Oral Pain and Morbidity. Eur Urol. 2018 Jun;73(6):910–22.

6.         Jonnavithula N, Bachu D, Sriramoju V, Devraj R, Gunta R, Pisapati MurthyVLN. Effect of infraorbital nerve block on postoperative pain and 30-day morbidity at the donor site in buccal mucosal graft urethroplasty. J Anaesthesiol Clin Pharmacol. 2019;35(1):114.

 

 
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