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CTRI Number  CTRI/2019/11/022114 [Registered on: 22/11/2019] Trial Registered Prospectively
Last Modified On: 20/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Usefulness of local anesthetic injection around the nerve, before surgery, on drug requirement to reduce pain in patients undergoing nasal surgeries.  
Scientific Title of Study   Effectiveness of pre-emptive nerve block on opioid consumption in patients undergoing nasal surgeries under general anesthesia - A Double Blinded Randomized Controlled Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KRISHNAPRIYANKA K J 
Designation  Post-graduate,MD Anaesthesiology 
Affiliation  Mahatma Gandhi medical college and research institute  
Address  Mahatma Gandhi Medical College and Research Institute,Pondicherry,cuddalore ECR road, puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9962996740  
Fax    
Email  krishnakarpagaraj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PARTHASARATHY S 
Designation  Professor, MD Anaesthesiology 
Affiliation  Mahatma Gandhi medical college and research institute  
Address  Mahatma Gandhi Medical College and Research Institute, Pondicherry.

Pondicherry
PONDICHERRY
607402
India 
Phone  9047034042  
Fax    
Email  painfreepartha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PARTHASARATHY S 
Designation  Professor, MD Anaesthesiology 
Affiliation  Mahatma Gandhi medical college and research institute  
Address  Mahatma Gandhi Medical College and Research Institute, Pondicherry.

Pondicherry
PONDICHERRY
607402
India 
Phone  9047034042  
Fax    
Email  painfreepartha@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute, Pondicherry 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Research Institite 
Address  pillayarkuppam,Pondicherry,cuddalore ECR road, Puducherry-607402 
Type of Sponsor  Private 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 
krishnapriyanka k J  Mahatma Gandhi Medical College and Research Institute  department of anaesthesiology MGMCRI
Pondicherry
PONDICHERRY 
9962996740

krishnakarpagaraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethics committee, SRI BALAJI VIDYAPEETH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J348||Other specified disorders of noseand nasal sinuses,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  general anesthesia without nerve block  perioperative pain will be managed with intravenous analgesics by monitoring pain response in vital parameter as per standard of care. 
Intervention  preemptive peripheral nerve block with local anesthetic before general anesthesia   One time administration of local anesthetic injection maxillary and nasocilliary nerve before giving general anesthesia(before surgery)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1and 2 
 
ExclusionCriteria 
Details  patient refusal, allergic to local anesthetic, infection at injection site, bleeding disorder 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Intraoperative fentanyl demand   Intraoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
Emergence characteristics
a. Grade of cough
b. Grade of emergence agitation

Recovery characteristics
c. Grade of PONV
d. Time to first analgesia
e. Time to PACU discharge
 
a. during extubation
b. immediately after extubation
c. in postoperative period
d. in postoperative period
e. in postoperative period 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/12/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Nasal surgeries done under general anaesthesia produces mild to moderate postoperative pain. However these surgeries can still produce unexpectedly high levels of postoperative pain. In addition to perioperative pain, the performance of nasal surgery under general anaesthesia alone is an independent risk factor for emergence agitation which may lead to serious complications such as hypoxia, aspiration, bleeding or reoperation. Facial nerve blocks are described for nasal surgeries, but their use as sole anaesthetic technique for nasal procedures with prolonged duration and risk of bleeding is limited. Among these described nerve blocks, nasociliary and maxillary nerves forms the major contributing nerve supply of nose, nasal mucosa, septum and nasal cavity. Therefore, blocking of these nerves provide superior pain relief without clinically significant side effects for nasal surgeries. However, the benefits of these nerve blocks when combined with general anaesthesia, if any, on intraoperative opioids consumption and postoperative recovery outcomes in  nasal surgeries with longer duration and risk of bleeding have not been previously studied. Thus, we designed this study to test the primary hypothesis that the addition of bilateral maxillary and nasociliary nerve blocks to a standardized general anaesthetic decreases the intraoperative opioids consumption following nasal surgery. We also sought to determine the effect of bilateral maxillary and nasociliary nerve blocks on the emergence and recovery characteristics.

 
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