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CTRI Number  CTRI/2024/11/076182 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Addition of a drug dexmedtomidine during pain relief for procedures on uterus 
Scientific Title of Study   Dexmedetomidine as an adjuvant to lignocaine in paracervical block for daycare hysteroscopic procedures: a 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  Aysha Rinsha T P 
Designation  Junior Resident  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. 
Address  Department of Anesthesiology and Critical Care Anesthesia Office 2nd Floor IPD block Jawaharlal Institute of Postgraduate Medical Education and Research Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8921953878  
Fax    
Email  aysharinshatp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suman Lata  
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. 
Address  Department of Anesthesiology and Critical Care Anesthesia Office 2nd floor Institute Block Jawaharlal Institute of Postgraduate Medical Education and Research Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9487315913  
Fax    
Email  jd0330@jipmer.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Suman Lata  
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. 
Address  Department of Anesthesiology and Critical Care Anesthesia Office 2nd floor Institute Block Jawaharlal Institute of Postgraduate Medical Education and Research Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9487315913  
Fax    
Email  jd0330@jipmer.ac.in  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. 
 
Primary Sponsor  
Name  Aysha Rinsha T P 
Address  Junior Resident, Department of Anesthesiology and Critical Care, Anesthesia Office, 2nd Floor IPD Block, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry. 
Type of Sponsor  Other [Self] 
 
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 Suman Lata Gupta  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)   Department of Anesthesiology and Critical Care 2nd Floor IPD block JIPMER Pondicherry
Pondicherry
PONDICHERRY 		 9487315913

jd0330@jipmer.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Interventional Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, (2) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Dose:50 mcg (0.5 ml of dexmedetomidine of concentration 100 mcg per ml)added to 10 ml of 2% lignocaine making a total volume of 10.5 ml given as paracervical block at 5 o clock and 7 o clock positions of the cervix 
Comparator Agent  Normal saline   0.5 ml of Normal saline added to 10 ml of 2% lignocaine making a total volume of 10.5 ml given as paracervical block at 5 O clock and 7 O clock positions of the cervix 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Women of age 18-65 years undergoing outpatient hysteroscopy under paracervical block 
 
ExclusionCriteria 
Details  Women with following conditions:
(i)Pregnancy
(ii)bradycardia or heart block
(iii)known cardiac disease
(iv)coagulopathy
(v)refusal to consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of dexmedetomidine as an adjuvant in paracervical block on intraprocedural pain assessed by Visual Analog Scale  15 minutes interval till 2 hours after the procedures 
 
Secondary Outcome  
Outcome  TimePoints 
Perioperative rescue analgesic requirement  From time of insertion of hysteroscope into the uterus ,every 15 minutes until procedure is over and after the procedure for a period of 2 hours 
Patient satisfaction measured using Likert Scale  Two hours after the hysteroscopy 
Incidence of premature termination and interruption of procedure due to pain  After the insertion of hysteroscope into the uterus until hysteroscopy is completed 
Incidence of nausea, vomiting and giddiness.  From the time of giving paracervical block until two hours after the hysteroscopic procedure 
Duration of analgesia  From time of completion of paracervical block to request of first rescue analgesic. 
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
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)   04/11/2024 
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 Yet Recruiting 
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  
Background
Hysteroscopy, a common outpatient procedure, causes significant pain and discomfort. Effective pain management strategies are still evolving.

Current Pain Management
Several measures are used to minimize pain:
- General anesthesia
- Intravenous sedation
- Inhalational anesthesia
- Analgesics
- Spinal anesthesia
- Paracervical block

Paracervical Block Limitations
Studies show inconsistent pain relief with paracervical block using local anesthetics.

Dexmedetomidine Potential
Dexmedetomidine, an α2-adrenergic receptor agonist, enhances analgesic efficacy in neuraxial and peripheral nerve blocks.

Research Gap
No studies have assessed dexmedetomidine’s efficacy as an adjuvant in paracervical block for hysteroscopy.

Hypothesis
Adding dexmedetomidine to lignocaine will reduce intraoperative pain and improve patient satisfaction during diagnostic and therapeutic hysteroscopy.
This study aims to investigate the potential benefits of combining dexmedetomidine with lignocaine in paracervical block for pain management during hysteroscopic procedures.

The study will begin after obtaining approval from the PGRMC and Institute Ethics Committee.
Patient Selection:
Patients visiting the gynecology OPD for diagnostic and therapeutic hysteroscopic evaluation will be assessed for eligibility.
Preoperative Assessment:
A written informed consent will be obtained, followed by a preoperative assessment on the day of hysteroscopy, including:
- History
- Physical examination
- Blood investigations
- USG reports
Group Assignment
Patients will be randomly assigned to one of two groups:
- Group 1: Paracervical block with lignocaine and dexmedetomidine
- Group 2: Paracervical block with lignocaine and normal saline

Procedure
After shifting the patient to the table, ECG leads, pulse oximeter, noninvasive blood pressure cuff will be attached to the patient for monitoring. IV line will be secured for giving rescue analgesia if required. Patient will be positioned in lithotomy position and paracervical block will be given at 5 O clock and 7 O clock positions of the cervix. Hysteroscope will be inserted 5 minutes after giving paracervical block. Pain will be monitored using the Visual Analog Score (VAS)every 15 minutes from the insertion of hysteroscope until the procedure is over and then every 15 minutes for a period of two hours post procedure. Heart rate, blood pressure and SpO2 of the patient will be monitored and recorded every 5 minutes during the procedure. After the procedure is over these parameters will be monitored and recorded at every 15 minutes until 2 hours post procedure.

Pain Management
Incremental boluses of fentanyl (25 mcg) will be administered if intraprocedural VAS is > 4.If pain persists, the procedure may be abandoned and rescheduled according to the discretion of gynaecologist. Post procedural pain with VAS>4 will be managed by intravenous ketorolac 50 mg followed by intravenous tramadol 50 mg if VAS persists above 4.

Outcome Measures
- VAS for pain
- Duration of analgesia
- Number of interruptions/abandonments due to pain
- Patient satisfaction (Likert scale)
- Incidence of nausea, vomiting, and giddiness
Management of possible adverse events:
Bradycardia (HR<60/min) will be managed using bolus of atropine (0.3mg) while bradycardia with hypotension (<80% of fall in systolic blood pressure or SBP<90 mm of Hg) will be managed with Atropine 0.6 mg iv bolus, can be repeated every 3-5 mins to a maximum dose of 3 mg.

This study’s findings will contribute to optimizing pain management strategies for hysteroscopic procedures.

 
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