| CTRI Number |
CTRI/2026/04/107224 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study tested whether lignocaine or fentanyl helps patients recover more smoothly after ear surgery by looking at overall well-being instead of just pain |
|
Scientific Title of Study
|
Evaluation of postoperative recovery using QOR 15 following intravenous lignocaine versus fentanyl in patients undergoing tympanomastoid surgery under general anesthesia A double blinded randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PAMUGALLA MYTHILI |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences Raipur |
| Address |
Super Speciality Ot Complex B block Department Of Anesthesiology And Critical Care All India Institute Of Medical Sciences Raipur Tatibandh Raipur Chhattisgarh 492099 India
Raipur
CHHATTISGARH
492099
India |
| Phone |
9908911665 |
| Fax |
|
| Email |
vidyacharan9999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica Malhotra |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences Raipur |
| Address |
Super Speciality Ot Complex B block Department Of Anesthesiology And Critical Care All India Institute Of Medical Sciences Raipur Tatibandh Raipur Chhattisgarh 492099 India
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881714 |
| Fax |
|
| Email |
monicakhetrapal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica Malhotra |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences Raipur |
| Address |
Super Speciality Ot Complex B block Department Of Anesthesiology And Critical Care All India Institute Of Medical Sciences Raipur Tatibandh Raipur Chhattisgarh 492099 India
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881714 |
| Fax |
|
| Email |
monicakhetrapal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Tatibandh Raipur Chhattisgarh 492099 India |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
Super Speciality Ot Complex B Block Department Of Anesthesiology And Critical Care All India Institute Of Medical Sciences Tatibandh Raipur Chhattisgarh 492099 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr PAMUGALLA MYTHILI |
All India Insitute Of Medical Sciences |
Super Speciality Ot Complex B block Department Of Anesthesiology And Critical Care All India Institute Of Medical Sciences Raipur New Administrative Building B Block Gate number 4 Tatibandh Raipur Chhattisgarh 492099 India
Raipur
CHHATTISGARH |
9908911665
vidyacharan9999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AiimsRaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
iv fentanyl2 mcg kg as a bolus followed by continous infusion of 1mcg kg hr |
iv fentanyl continous infusion ot 1 mcg kg hr intraoperatively and duration of intervention depends on duration of surgery and stopped 20 mins of surgery ends |
| Intervention |
IV lignocaine 1.5 mg as a bolus followed by continous infusion at at 1.5 mg/kg/hr |
IV Lignocaine continous infusion 1.5 mg kg hr intraoperatively Duration of intervention depends on duration of surgery and stopped before 20 mins of surgery ends |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status class 1 2
Scheduled for elective tympanomastoidectomy |
|
| ExclusionCriteria |
| Details |
Patients with hypersensitivity to local anaesthetics
Patients with chronic pain on opioids
Inability to understand vas score
Body mass index of greater than 30
Ptient with hepatic renal or cardiac insufficiency pregnant and lactating mothers |
|
|
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 |
| To compare quality of recovery following administration of iv lignocaine with that of fentanyl using QOR 15 questionnaire |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess post operative analgesia requirement |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
30/04/2026 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Quality of recovery QOR 15 is an essential patient centered measure following surgery evaluating aspects beyond traditional pain scores and discharge times The QOR 15 questionnaire assess five domains physical comfort emotional state psychological support physical independence and pain providing a comprehensive view of recovery Intravenous iv lignocaine is increasingly used perioperatively for its local anesthetic and systemic analgesic anti hyperalgesic and anti inflammatory properties It reduces opioid and anesthetic requirements decreses post operative pain improves bowel function and shortens hospital stay This makes lignocaine a key part of multimodal analgesia and enhances recovery after surgery protocols Fentanyl though effective for intraoperative pain control has its side effects like nausea sedation delayed recovery driving the shift towards opioid sparing techniques The superficial cervical plexus block is effective for neck surgeries like tympanomastoid procedures reducing the opioid use and enhancing analgesia This study compares the effects of iv lignocaine versus fentanyl on QOR 15 scores in tympanomastoid surgery patients to improve recovery and reduce opioid related side effects |