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CTRI Number  CTRI/2020/07/026312 [Registered on: 02/07/2020] Trial Registered Prospectively
Last Modified On: 10/10/2021
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   Image guided pain relief with local anaesthesia in patient undergoing laparoscopic cholecystectomy  
Scientific Title of Study   A prospective comparative study on USG guided erector spinae block versus local infiltration on port site for post-operative pain management of adult patient undergoing laparoscopic cholecystectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parul Jindal 
Designation  Professor 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Anesthesia Himalayan Institute of Medical Sciences, Swami Rama Himalayan University

Dehradun
UTTARANCHAL
248140
India 
Phone  9456547229  
Fax    
Email  parulpjindal@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Yashita Joshi 
Designation  Postgraduate Resident 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Anesthesia Himalayan Institute of Medical Sciences, Swami Rama Himalayan University

Dehradun
UTTARANCHAL
248140
India 
Phone  9897911206  
Fax    
Email  yashita201095@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parul Jindal 
Designation  Professor 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Anesthesia Himalayan Institute of Medical Sciences, Swami Rama Himalayan University

Dehradun
UTTARANCHAL
248140
India 
Phone  9456547229  
Fax    
Email  parulpjindal@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Himalayan Institute of Medical Sciences, Swami Ram Nagar, Jollygrant Dehradun 
 
Primary Sponsor  
Name  Himalayan Institute of Medical Sciences 
Address  Himalayan Institute of Medical Sciences Swami Rama Himalayan University Dehradun  
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 Parul Jindal  Himalayan Institute of Medical Sciences  Induction room, pre op area, operation theatere 2nd floor, Department of anaesthesia,Cancer Research Institute, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, jollygrant
Dehradun
UTTARANCHAL 		 9456547229

parulpjindal@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group I- Patients will recieve only general anesthesia  Patients will recieve only general anesthesia 
Comparator Agent  Group II- Patients will recieve port site infilteration with General anesthesia   Patients will recieve general anesthesia and before the incision, infiltration of all the port side will be done with 20ml of 0.375% bupivacaine through all the layers of the abdominal wall till peritoneum. Four ports will be created. In two ports of 10mm, 6ml of drug will be infiltrated in each port and in the other two ports of 5mm each 4ml of drug will be infiltrated.  
Intervention  Group III- Patients will recieve erector spinae block with general anesthesia  Patient will be taken to the procedure room and erector spinae block will be given at T7 level bilaterally with 20ml bupivacaine 0.375% on one side and then the same amount of drug on the other side. Patient will be observed for 30 mins following the block and sensory level will be assessed. After 30 minutes patient will be shifted to the operation room and general anesthesia will be given. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA physical status I and II of either sex
2. Age between 18-65 years
3. Scheduled for laproscopic cholecystectomy surgery 
 
ExclusionCriteria 
Details  1. American Society of Anesthesiologist (ASA) physical status III and IV and Emergency surgeries
2. Patient refusal for regional anesthesia.
3. Presence of spine deformities.
4. Allergy or contraindication to study drugs.
5. Pregnancy, lactating mothers.
6. BMI more than or equal to 35 kg/m2.
7. Chronic pain
8. Hepatic, renal or cardiopulmonary abnormality, uncontrolled diabetes, seizures
9. Bleeding diathesis
10.Local skin site infection 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study post operative pain and fentanyl sparing effect after erector spinae block following laparoscopic cholecystectomy  To study total fentanyl consumption over 24 hrs and to study pain intensity at 0,15,30 mins, 1,2,3,4,6,8,10,12,16,20 and 24 hrs interval respectively 
 
Secondary Outcome  
Outcome  TimePoints 
To study hemodynamics and adverse effects after ultrasound guided erector spinae block in patients undergoing laparoscopic cholecystectomy.  Preoperatively (baseline), immediately after block 0.5,10,15,20,25,30, during induction and intubation, intraoperatively at 5,10,15,20,25,30,45,60,75,90,105,120 mins and postoperatively at 0,15,30 mins, 1,2,3,4,6,8,10,12,16,20 and 24 hrs interval respectively. 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   02/07/2020 
Date of Study Completion (India) 01/09/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/09/2021 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [yashita201095@gmail.com].

  6. For how long will this data be available start date provided 01-10-2021 and end date provided 01-05-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  

Laparoscopic cholecystectomy has become the procedure of choice for routine gall bladder removal. It is currently the most commonly performed major abdominal procedure. One of the greatest advantages with laparoscopic procedures is that patients can be discharged on the same day (day care surgeries). The success of any day care procedure depends highly on the postoperative pain management of the patient.

Intraoperatively, in laparoscopic cholecystectomy access is provided with small ports created on the anterior abdominal wall. In spite of these small ports, laparoscopic cholecystectomy causes moderate to severe post-operative pain. This pain is partly due to segmental innervation of nociceptor afferent pathways along the trans abdominal fascial plane. The pain can be due to; incisional pain from the port site i.e. somatic pain, local visceral pain (deep abdominal pain), parietal pain and referred visceral pain. The visceral pain that occurs with tissue trauma during gall bladder resection is the most predominant component.


Currently several therapeutic options like non-steroidal anti-inflammatory drugs, opioids, dexamethasone, port site infiltration with local anaesthetic drugs, transversus abdominus block and oblique subcostal abdominis plane block have been used. .In spite of a great control of pain with opioid, perioperative physicians are still looking forward to newer techniques. One of the reasons being the side effects associated with opioids. Despite all the currently available multimodal analgesic regimes, laparoscopic cholecystectomy is still associated with moderate to severe post-operative pain.

Erector spinae block (ESP) is a new technique of regional anaesthesia. The technique was originally described by Forero et al in 2016, when it was used to treat thoracic neuropathic pain. The reason this block is gaining popularity is because it blocks both somatic and visceral pain and is thus suitable for laparoscopic upper abdominal surgery.

The erector spinae block is performed under ultrasonographic guidance by injecting local anesthetic solution between the erector spinae muscles and the transverse process. The local anaesthetic then spreads into the para vertebral space through diffusion between adjacent vertebrae. Thus, it acts on both dorsal and ventral branches of the spinal nerves.

The safety profile of ESP block is better than any other regional anesthesia. First, it is performed under ultrasound guidance so the anatomy is easily identifiable, second it acts on both somatic and visceral pain and third, this technique targets transverse process which is easily identifiable. Transverse process is distant from major vascular, neural structures and the pleura. It provides extensive analgesia with a single puncture.

The study is designed to compare and evaluate the effect of ultrasound guided erector spinae block and port site instillation on the duration and quality of postoperative analgesia, analgesic requirement and patient satisfaction in patients undergoing laparoscopic cholecystectomy.

Sample size:     

With reference to previous study(3), the sample size was determined by using the VAS to compare the effectiveness by assuming a difference of 1 in VAS between any two groups as clinically significant, thus sample size of 35 patients per group were considered necessary to detect statistical significances with an effect size of 0.67 at alpha 0.05 and power of 80%.

 

 

The formula for calculated sample size is given below

 

n = (σ12 + σ22). [Z 1- α/2 + Z 1- β]2

                            (M1 - M2) 2

= (1.52 + 1.52).[1.96+0.842] 2

               (1*1)

 = (2.25+ 2.25)*7.85

             1

= 35.325

where Zα/2 is the critical value of the Normal distribution at α/2 (e.g. for a confidence level of 95%, α is 0.05 and the critical value is 1.96), Zβ is the critical value of the Normal distribution at β (e.g. for a power of 80%, β is 0.2 and its critical value is 0.842) and σ 1 and σ 2 are the Standard deviations of the two groups and M1 and M2 are the means of two groups.







 
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