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CTRI Number  CTRI/2024/05/067713 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 20/05/2024
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   Technique used in the control of pain after Haemorrhoids surgery and is effect on decreasing pain after Haemorrhoids Surgery 
Scientific Title of Study   Effects of Ultrasound guided Pudendal Nerve block on post operative pain and quality of recovery in patients undergoing hemorrhoidectomy under Spinal Anaesthesia :A Randomised Control Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Kamalieshree M 
Designation  Post Graduate Student 
Affiliation  Bangalore Medical College and Research Institute  
Address  3rd floor MPB building,Department of Anaesthesiology,Victoria hospital,Bangalore Medical college and Research Institute,Fort,Krishna Rajendra Rd,kalasipalya,Bengaluru,Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  8608021339  
Fax    
Email  kamaliteja@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Bhaskara B 
Designation  Associate professor 
Affiliation  Bangalore Medical College and Research Institute. 
Address  3rd floor MPB building,Department of Anaesthesiology,Victoria hospital,Bangalore Medical college and Research Institute,Fort,Krishna Rajendra Rd,kalasipalya,Bengaluru,Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9902016020  
Fax    
Email  drbhaskar.md@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Bhaskara B 
Designation  Associate professor 
Affiliation  Bangalore Medical College and Research Institute. 
Address  3rd floor MPB building,Department of Anaesthesiology,Victoria hospital,Bangalore Medical college and Research Institute,Fort,Krishna Rajendra Rd,kalasipalya,Bengaluru,Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9902016020  
Fax    
Email  drbhaskar.md@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute.KR road,Fort,Bengaluru, Karanataka-560002 INDIA 
 
Primary Sponsor  
Name  DR Kamalieshree M 
Address  3rd floor, MPB building, Department of Anaesthesiology, Victoria Hospital, Bangalore Medical College and Research Institute, KR road, Fort, Bengaluru,Karnataka 560002,INDIA 
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 Kamalieshree M  Bangalore Medical College and Research Institute.  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru. Bangalore KARNATAKA 9080537427 revaanth1996@gmail.c om Details of Ethics Committee Name of Committee Approval Status Date of Approval
Bangalore
KARNATAKA 
8608021339

kamaliteja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  patients undergoing open haemorrhoidectomy under spinal anaesthesia only  patients undergoing open haemorrhoidectomy under spinal anaesthesia only 
Intervention  ultrasound guided Pudendal Nerve Block with Inj Ropivacaine0.75% in patients undergoing open haemorrhoidectomy under spinal anaesthesia  patients undergoing haemorrhoidectomy under spinal anaesthesia plus pudendal nerve block under ultrasound guidance and its effect on post operative analgesia at 6hours  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to give informed consent
Patients posted for electiv haemorrhoidectomy
patients with ASA grade 1 and ASA grade 2  
 
ExclusionCriteria 
Details  patients refusal in giving informed consent
Age less than 18 years
patients allergic to local anaesthetics
patients with bledding diathesis,skin lesions,wound at the puncture site of proposed block
pregnant and lactating women ASA grade 3 and ASA grade 4 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of pudendal nerve block with spinal anaesthesia versus only spinal anaesthesia on postoperative pain (VAS score)at 6th hour in patients undergoing haemorrhoidectomy   immediate post op , 6th hour 
 
Secondary Outcome  
Outcome  TimePoints 
To asses the quality of recovery in patients undergoing Haemorrhoidectomy  Immediate post op ,6th hour  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   31/05/2024 
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="1"
Months="6"
Days="30" 
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  
The anesthetic procedure will be standardized. Pre anaesthetic evaluation and
relevant investigations will be advised with standard nil per oral instructions.
In the preoperative area patient will be connected to monitors and baseline
Systolic Blood Pressure (SBP), Diastolic blood pressure (DBP) , Respiratory
rate (RR) ,Heart rate(HR),Oxygen saturation (SPO2) will be monitored and
study drug will be prepared by the nurse not involved in the study.
ï‚· In the pre operative room, intravenous line of 18 G are established. Patient is
started with 500ml of Ringer lactate solution.A brief explanation of the
procedure and the type of anaesthesia to be given is explained to the patient.
ï‚· Once the patient gets shifted inside the OT, all the monitors are
connected.Patient’s basal parameters –Heart rate, saturation, blood pressure
and ECG, will be monitored using pulse-oximetry, non invasive blood pressure
and ECG monitor. Under sterile aseptic precautions parts painted and draped
patient in sitting or lateral position, under local anaesthesia,using midline
approach, Lumbar puncture is done under the L3-L4 intervertebral space using
25G Quinckes spinal needle, once the clear and free flow of CSF is noted
,Inj.Bupivacaine 0.5% (H )of 2ml without additive agents is given,
after the spinal injection patient is repositioned.

Pudendal nerve block was performed after the spinal Anaesthesia, a low-
frequency 2–5-MHz curved array ultrasound Probe allowed the visualization

of important landmarks: the Ischial spine, pudendal artery, sacrospinous
ligament, Sacrotuberous ligament, and pudendal nerve. After sterile skin And
probe preparation within a transparent plastic sheath,Scanning is performed in
transverse planes to visualize the Ischium forming the lateral border of the
sciatic notch. By Moving the ultrasound probe in a cephalad-caudal
direction,The ischium appears as a progressively lengthening Hyperechoic line
that is widest at the ischial spine level. The Ischium is initially seen as a curved

line as it forms the Posterior aspect of the acetabulum. When the probe is at
The ischial spine level, the ischium will appear as a straight Line. At this level,
a color Doppler is used to localize the Internal pudendal artery pulsations in
close proximity to the Ischial spine. The inferior gluteal artery is often seen as
another arterial pulsation lateral to the tip of the ischial spine and is
Accompanied by the sciatic nerve—mistaking this artery for The pudendal
artery could result in sciatic nerve block. The Sacrospinous ligament will
appear as a hyperechoic line in continuity with the ischial spine, with lower
echogenicity than Bone. Similarly, the sacrotuberous ligament is seen as a light
Hyperechoic line deep within the gluteus maximus muscle and appeared
parallel and superior to the sacrospinous ligament. The localization of the
pudendal nerve is targeted in the Plane between these two ligaments. Under
ultrasound guidance, a peripheral nerve–stimulating needle is inserted and
Advanced in line with the ultrasound probe, medial to the Internal pudendal
artery. Once the needle passes through the Sacrotuberous ligament, a “click” is
usually felt and a small Volume (1–2 mL) of local anesthetic is injected. The
solution appeared as a hypoechoic collection, in order to identify The plane
between the sacrotuberous and the sacrospinous ligaments and to accentuate
the pudendal nerve appearance.The needle is inserted medially toward the
pudendal artery, as the pudendal nerve is generally located medial to this
artery. Ten Milliliters of ropivacaine 0.75% was injected within this fascial
plane, after negative aspiration. The procedure was then Repeated identically
on the contralateral side.Thirty minutes later, if the sensation of the skin
around the anus and the contractility of the anus is decreased this indicates that
the pudendal nerve is successfully blocked

. After the completion of the
surgical procedure patient gets shifted into the post Anaesthesia care unit
where the vitals of the patients including the post operative pain will be
monitored using the visual analogue scale (VAS) ( Annexure 4). Post operative
pain on the visual analogue scale at 6 hours , along with opioid, NSAIDs
administration and length of hospital stay is recorded.
 
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