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CTRI Number  CTRI/2023/04/051796 [Registered on: 20/04/2023] Trial Registered Prospectively
Last Modified On: 16/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two types of nerve blocks for analgesia following hip surgeries 
Scientific Title of Study   Comparison of pericapsular nerve group and lateral femoral cutaneous nerve block combination with fascia iliaca block for postoperative analgesia in hip surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gayathri Annaselvam 
Designation  Junior resident 
Affiliation  KS Hegde Medical Academy 
Address  Department of Anaesthesiology, KS Hegde Medical Academy, Derlakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9362974182  
Fax    
Email  gayathriannaselvam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sripada G Mehandale 
Designation  Head of the department  
Affiliation  KS Hegde Medical Academy  
Address  Department of Anaesthesiology, KS Hegde Medical Academy, Derlakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448384310  
Fax    
Email  sripadamehandale@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sripada G Mehandale 
Designation  Head of the department 
Affiliation  KS Hegde Medical Academy  
Address  Department of Anaesthesiology, KS Hegde Medical Academy, Derlakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448384310  
Fax    
Email  sripadamehandale@nitte.edu.in  
 
Source of Monetary or Material Support  
Justice KS Hegde Charitable hospital 
 
Primary Sponsor  
Name  Dr Sripada G Mehandale 
Address  Department of Anesthesiology, KS Hegde Medical Academy, Deralakatte, Karnataka 575018 
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 
Gayathri Annaselvam  KS Hegde Medical Academy  Department of Anaesthesiology, KS Hegde Medical Academy, Derlakatte
Dakshina Kannada
KARNATAKA 		 9362974182

gayathriannaselvam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central ethics committee Nitte (Deemed to be university)  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 
Intervention  Combination of Pericapsular Nerve Group and lateral femoral cutaneous nerve block   0.4 ml/kg of 0.25% bupivacaine with 1 mcg/kg of dexmedetomidine 
Comparator Agent  Fascia iliaca block  0.4 ml/kg of 0.25% bupivacaine with 1 mcg/kg of dexmedetomidine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged more than 18 years undergoing hip surgeries
American Society of Anaesthesiologist Physical Status 1 2 and 3
 
 
ExclusionCriteria 
Details  Patients undergoing multiple procedures, including bone grafting from other sites
Patients with other fractures like distal femur, tibia and fibula
Patients allergic to drugs used in the study
History of long-term opioid or other analgesic consumption
Patients with bleeding or coagulation disorders
Patients with any neurological or musculoskeletal disorders
Any contraindication for the blocks used in the study
Infection or lesion at the site of block
Patients with heart block, hypotension, bradycardia, cardiac failure
 
 
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 
The intensity of pain in the first 24 hours measured with NRS  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first rescue analgesia
Total dose of analgesics required in the first 24 hours post-surgery
Patient satisfaction with postoperative analgesia at the end of 24 hours
Quadriceps muscle power
 		 24 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/04/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
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

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to gayathriannaselvam@gmail.com

  6. For how long will this data be available start date provided 01-08-2023 and end date provided 01-08-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Patients satisfying the selection criteria will be enrolled and informed written consent will be obtained. NPO guidelines and premedications will be followed as per standard guidelines. NRS will be explained to the patient before the surgery. After shifting to operation theatre, baseline vitals will be noted. Group allocation will be done as per the random numbers generated by the computer.
Group P will receive ultrasound-guided PENG with LFCN block
Group F will receive ultrasound-guided suprainguinal FIB

The subarachnoid block will be given to the patient in sitting position with a 25 gauge Quincke-Babcock needle with 0.5% Inj. Bupivacaine (hyperbaric). The amount of drug for SAB will be decided by the anaesthesiologist in charge of the patient according to the need of the surgical procedure to provide effective anaesthesia throughout the procedure.

At the end of the procedure, the sensory and motor level of spinal anaesthesia will be assessed and noted. 
The sensory level of the blockade will be assessed in the midclavicular line bilaterally with a cotton swab dipped in spirit and the highest dermatome blocked will be noted.
The motor level of the blockade will be assessed by the modified Bromage scale.

As per group allocation, either of the blocks will be given.
Group P: A solution of 0.4ml/kg of 0.25% bupivacaine with 1 mcg/kg of dexmedetomidine will be prepared.
PENG block: 0.3 ml/kg of 0.25% bupivacaine with 1 mcg/kg of dexmedetomidine will be given. 
LFCN block: The remaining solution will be given.
Group F: 0.4 ml/kg of 0.25% bupivacaine with 1 mcg/kg of dexmedetomidine will be given for FIB.

After performing the block, the patient will be shifted to PACU.
The following parameters will be recorded at 0, 30, 60 min and thereafter 2nd, 4th, 6th, 8th, 12th and 24th hour in the post-operative period:
  • NRS score for pain at rest and while flexing and extending hip joint
  • Heart rate
  • SBP, DBP and MAP
  • Sedation with Brussels’ sedation score
  • Level of sensory blockade due to spinal anaesthesia till it regresses to T12 (just above inguinal ligament)
  • Lower limb motor power on the opposite side till full motor recovery from spinal anaesthesia (modified Bromage scale score - 6)
  • Quadriceps muscle power on both sides
  • Any adverse effects including nausea, vomiting, restlessness, urinary retention and treated appropriately.
  • Patient satisfaction with NRS at 24 hours
  • Time to first rescue analgesia – It is the time interval between the time at which the PENG with LFCN block or FIB is performed and the time at which first rescue analgesia is given.

If NRS for pain >5 or whenever patient demands, rescue analgesia with Inj. Tramadol 0.5 mg/kg bolus will be given intravenously and recorded along with a pain score at that time.
 
 
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