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CTRI Number  CTRI/2024/06/068386 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 05/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   This study was conducted to use and determine efficacy of isobaric drug levobupivacaine administered via spinal anesthesia in laparoscopic surgeries  
Scientific Title of Study   Efficacy of isobaric intrathecal levobupivacine in laproscopic procedures : Case series 
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 Maninder Singh Bugalia  
Designation  Pg resident  
Affiliation  Mahatma Gandhi medical college and hospital  
Address  Department of Anesthesiology, Critical Care and Pain Management MGMC&H, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  7568989613  
Fax    
Email  maninder15081997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Khayyam  
Designation  Professor 
Affiliation  Mahatma Gandhi medical college and hospital  
Address  Department of Anesthesiology, Critical Care and Pain Management MGMC&H, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9468964148  
Fax    
Email  khayyammoin@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vigya Goyal  
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi medical college and hospital  
Address  Department of Anesthesiology, Critical Care and Pain Management MGMC&H, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8349249511  
Fax    
Email  Goyalvigya@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi medical college and hospital , sitapura, Jaipur , Rajasthan, India. 302022 
 
Primary Sponsor  
Name  Mahatma Gandhi medical college and hospital  
Address  Department of anesthesia and critical care , Mahatma Gandhi medical college and hospital ,sitapura , Jaipur , Rajasthan India 302022 
Type of Sponsor  Private medical college 
 
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 Maninder Singh Bugalia   Mahatma Gandhi hospital  Mahatma Gandhi medical college and hospital
Jaipur
RAJASTHAN 
7568989613

maninder15081997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutionalethicscommittee Mahatma Gandhi medical college and hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (2) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Efficacy of isobaric intrathecal levobupivacine in laproscopic procedures : Case series   To determine efficacy of isobaric levobupivacaine in laparoscopic surgeries  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patient aged 18-65 years.
2 American Society of Anaesthesiology (ASA) of Classes I/ II
3 Patients undergoing laproscopic surgeries with duration less then 2 hours under spinal anaesthesia.
4 Patients giving consent for study
 
 
ExclusionCriteria 
Details  • Hypersensitivity to study medications
• Infection at the site of subarachnoid block
• Spinal deformities
• Inability to comprehend or participate in pain scoring system
• Patient with BMI more then 37kg/m2
• ECG changes like sinus bradycardia and heart blocks
• Patient on alpha adrenergic blockers
• Contraindication to spinal anaesthesia like bleeding diathesis and local Infection
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy and safety of single shot subarachnoid block
 
Pre-Induction
5 Minutes
10 Minutes
15 Minutes
20 Minutes
25 Minutes
30 Minutes

 
 
Secondary Outcome  
Outcome  TimePoints 
1 Haemodynamical changes
2 Time to first dose of rescue analgesia
3 Surgeon satisfaction score.
4. Patient satisfaction score
 
Post operativly for 24 hours 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   25/06/2024 
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="0"
Months="4"
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    After obtaining approval from the Institutional Ethics Committee, the study will be prospectively registered with the Clinical Trials Registry of India and will be conducted at our tertiary care centre.

This single-centre, prospective, interventional study will be conducted on 20  patients undergoing elective laparoscopic surgery, after obtaining written informed consent. Patients who are ASA grade 1 and 2 , Age 18-65 years will be included in the study.  

A sample size of 20 will be taken to ensure that the expected number of observations per category throughout our analysis will be well over the minimum data required for reliable chi-squared tests and to increase generalizability of our results.

The pre-anaesthetic check-up will be done, written informed consent will be taken and patients will be counselled about the procedure one day prior to surgery. They will be reassured that their discomfort or anxiety would be managed by the administration of systemic medication or GA if the need arose. Similarly, surgeons will be reassured that they could ask for GA if at any point during the surgery they felt that the anaesthetic technique is posing technical difficulty.

Patients will be kept fasting as per standard guidelines. 

After establishing monitoring (electrocardiogram, pulse oximetry, non-invasive blood pressure, respiratory rate and end-tidal carbon dioxide), baseline vitals will be noted and an intravenous line will be secured with a 20 gauge cannula. 

Pre-loading will be started at this juncture with Ringer lactate (10 ml/kg in approximately 15 minutes). Premedication with glycopyrrolate 0.2 mg, ondansetron 4 mg, and midazolam1 mg will given systemically. 

Under all aseptic precautions, sub arachnoid block will be given by midline approach in one of the intervertebral spaces between L1 to L3 spines, with the patient in a sitting position. If the midline approach posed a difficulty, then paramedian approach will be tried. The spinal will be given very cautiously, with a 25 G Quincke spinal needle, until loss of resistance is felt. Once the flow of clear CSF is established, injection levobupivacaine 0.5%(isobaric), 2ml, along with injection fentanyl 25 µg, (as adjuvant), is injected into the subarachnoid space. The patient is subsequently made to lie supine.

All patients will receive oxygen via Hudson’s mask at the flow rate of 5 l/min. Time of anaesthesia is recorded. Vital parameters are recorded every minute for 15 minutes and every 5 minutes thereafter. Upper and lower levels of sensory block are assessed by pinprick every 1-2 min until minimum block levels between T6 to L1 is achieved. 

This is noted as the time of onset. At this point in time, the motor block is evaluated according to the modified Bromage scale. (0-able to lift extended leg, 1- just able to flex knee, 2-no knee movement and some ankle movement, 3- complete lower limb paralysis). Once the onset of block is established surgery will be commenced using carbon dioxide insufflation. The pressure limit of intra-abdominal pressure(IAP) will be kept at 12 mm Hg. Intraoperative adverse events(bradycardia, hypotension etc) will be recorded and managed. Bradycardia (HR<55) will be treated with injection atropine 0.6mg (iv) and hypotension (Systolic BP<80 mm Hg) is managed with 6mg boluses of Injection mephentermine and fast (iv) fluids. Drugs and fluids administered are noted. The intraoperative fluid used will be ringer lactate at the rate of approximately 25ml/min. The rate of infusion can be increased during hypotension. In the end, the duration of surgery is noted.

Patient will be assessed for intraoperative shoulder pain according to visual analog score , and on the score of more than 3 patient is administered with inj fentanyl 100mcg iv .

In the recovery room, vital parameters, sensory and motor block is noted every 15 min until the block regressed completely. Pain scoring will be done as per the Visual Analogue Scale(VAS). Time of onset of postoperative pain (at VAS 3) is recorded. Injection Diclofenac 75 mg will be administered at this point.

Postoperative side–effects in the form of shoulder pain, nausea, vomiting, urinary retention, headache, backache will be noted and managed on day 0, day 1 and day 2. An overall procedure satisfaction score will be established individually for surgeon and patient based on 5 robust scoring criteria to evaluate the success of the procedure.

 

 

 
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