| CTRI Number |
CTRI/2023/05/052278 [Registered on: 03/05/2023] Trial Registered Prospectively |
| Last Modified On: |
02/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two methods of pain relief for middle ear surgery: Nerve block versus injection morphine. |
|
Scientific Title of Study
|
Comparison of superficial cervical plexus block and intravenous morphine for analgesia in tympanomastoid surgeries: Randomised double blind control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharmesh Arvind Ladhad |
| Designation |
Assistant Professor |
| Affiliation |
Karnataka institute of medical sciences, Hubli |
| Address |
Department of Anesthesiology,
Room no.206, IPD building,
Karnataka institute of medical sciences,
Vidyanagar, Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9482097491 |
| Fax |
|
| Email |
ladhaddharmesh@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dharmesh Arvind Ladhad |
| Designation |
Assistant Professor |
| Affiliation |
Karnataka institute of medical sciences, Hubli |
| Address |
Department of Anesthesiology, room no.206, IPD building,
Karnataka institute of medical sciences
Vidyanagar, Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9482097491 |
| Fax |
|
| Email |
ladhaddharmesh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dharmesh Arvind Ladhad |
| Designation |
Assistant Professor |
| Affiliation |
Karnataka institute of medical sciences, Hubli |
| Address |
Department of Anesthesiology,
Room no. 206, IPD building,
Karnataka institute of medical sciences, Vidyanagar, Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9482097491 |
| Fax |
|
| Email |
ladhaddharmesh@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of medical sciences, Hubli |
|
|
Primary Sponsor
|
| Name |
Karnataka Institute of medical sciences, Hubli |
| Address |
Karnataka institute of medical sciences, Vidyanagar, Hubli 580021 |
| Type of Sponsor |
Government 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 |
| Dharmesh Arvind Ladhad |
Karnataka Institte of medical sciences Hubli |
Department of Anaesthesiology, Room 206, IPD Building.
Vidyanagar , Hubli
Dharwad
KARNATAKA |
9482097491
ladhaddharmesh@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences,Hubballi EthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous morphine |
In patients group receiving morphine 0.1mg /kg morphine IV will be given after induction of general anaesthesia. |
| Intervention |
Superficial Cervical Plexus Block |
In patients of superficial cervical plexus block group , after induction of general anaesthesia ,the ipsilateral side of neck(on side of surgery) will be painted and drapped . Using 22 G hypodermic needle and 5 ml syringe 0.5 % bupivacaine will be injected at the posterior border of sternocleidomastoid muscle at the level of cricoid , which corresponds to approximately mid point of the muscle were the branches of the superficial cervicial plexus i.e greater auricular nerve and lesser occipital nerve emerge and these supply post auricular area , part of pinna and part of the external auditory canal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1 and 2 patients of either sex, undergoing tympanomastoid surgery.
2. Age 18 to 60 years
|
|
| ExclusionCriteria |
| Details |
1. Patients undergoing redo surgeries
2.Patients having associated associated facial nerve palcies and skull base osteomyelitis and meningitis.
3.PONV, motion sickness, migraine, history of seizures, malignancy, allergy to drugs used in the study.
4.Pregnancy and lactating mothers.
|
|
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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 |
Post operative pain will be assessed using VAS score at extubation and later at 1hr, 3hrs , 6hrs, 12 hrs and 24 hrs post surgery.
|
Postoperatively:1hr, 3hrs , 6hrs, 12 hrs and 24 hrs post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intra Operative vitals:
BP, PR at incision,and then at 15mins,30 mins, 1hr, 2hr, 3hrs.
2.Post operative sedation will be assessed at similar intervals using Ramsay sedation score.
3.Post operative nausea vomiting will observed and treated with intravenous ondansetron 4mg sos. |
Intra Operative vitals:
At incision,and then at 15mins,30 mins, 1hr, 2hr, 3hrs.
Postoperatively:1hr, 3hrs , 6hrs, 12 hrs and 24 hrs post surgery.
|
|
|
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)
|
13/05/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study:
To assess the effectiveness of superficial cervical plexus
block in providing post operative analgesia for tympanomastoid surgeries.
Objectives of the study:
1. Primary objective:
To compare superficial cervical plexus block V/S intravenous morphine in
providing post operative analgesia by visual analog score(VAS) for
tympanomastiod surgeries.
2. Secondary objectives:
A. Comparision of post operative nausea
and vomiting in patients receiving superficial cervical plexus block and in
those receiving morphine for analgesia.
B. Comparison of hemodynamic parameters
like heart rate(HR) and blood pressure(BP) in superficial cervical plexus block
group and morphine group. |