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
|
|
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
|
|
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. |