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CTRI Number  CTRI/2024/06/068436 [Registered on: 06/06/2024] 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   To study the factors causing rebound pain after peripheral nerve block in patients undergoing Trauma surgeries 
Scientific Title of Study   Incidence and risk factors associated with development of rebound pain after peripheral nerve block in trauma surgeries: an observational 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  Jeetinder Kaur Makkar 
Designation  professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh. 
Address  Department of Anaesthesia and Intensive care, 4t floor , A block, Nehru hospital, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  8847288105  
Fax    
Email  jeet1516@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jeetinder Kaur Makkar 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh. 
Address  Department of Anaesthesia and Intensive care, 4t floor , A block, Nehru hospital, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  8847288105  
Fax    
Email  jeet1516@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jeetinder Kaur Makkar 
Designation  professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh. 
Address  Department of Anaesthesia and Intensive care, 4t floor , A block, Nehru hospital, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  8847288105  
Fax    
Email  jeet1516@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, 4th floor, A block, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh. 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research (PGIMER), chandigarh  
Address  Department of Anaesthesia and Intensive Care, 4th floor, A block, Nehru Hospital, PGIMER, sector 12, Chandigarh  
Type of Sponsor  Research institution and hospital 
 
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 Jeetinder Kaur Makkar  Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh.  Operation Theatre Complex, 2nd floor, Advanced Trauma Centre, Department of anaesthesia and intensive care
Chandigarh
CHANDIGARH 
91-8847288105

jeet1516@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post Graduate Institute of Medical Education and Research,Chandigarh, Insitutional Ethics Committee (intramural)  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  Peripheral nerve Blocks- for upper limb - Brachial plexus block (supraclavicular or axilary approach), wrist block , for lower limb- sciatic nerve blcok, ankle blocks  The preoperative assessment of pain at rest and movement during the previous 24 hrs at the operative site will be assessed using a numeric rating scale (NRS) from 0 to 10 (where 0.no pain and 10 worst possible pain) In the operating room, procedure will be performed by treating anaesthesiologist as per institute protocol with dexamethasone 4mg as additive to volume of drug given for block. Volume of drug used in each block will be as follows- brachial plexus block (supraclavicular/infrqclavicular/axillary) - 15 ml of 0.5% bupivacaine, interscalene nerve block -10 ml of 0.5% bupivacaine. in Patients with lower limb surgeries, sciatic nerve block 20 ml of 0.5% bupivacaine, distal PNB will be administered 5 ml of 0.5% bupivacaine. Patients will be followed up for 24 hrs after surgery. Age, gender, BMI, baseline pain scores and ASA physical status will be included as patient factors. Surgical site and involvement of bone (e.g. debridement, fixation, amputation, tendon repair) will be included as surgical factors. Local anaesthetic type and dose, type of PNB will be included as anaesthetic factors. Type of PNB will be grouped as brachial plexus block (axillary, supraclavicular, or infraclavicular block), interscalene block (ISB), sciatic nerve block (subgluteal and popliteal blocks), and distal PNBs (e.g. ankle and wrist blocks). Pain scores in the PACU and post-discharge use of acetaminophen and NSAIDS will be included as postoperative factors. Durations of motor block and sensory block will be calculated from block time to when the patients reported motor and sensory resolution of the block, respectively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. age 18 years to 65 years having traumatic injuries of upper or lower limb
2. undergoing surgical procedure under peripheral nerve block
3. able to understand Numerical rating scale  
 
ExclusionCriteria 
Details  1,. patients who received peripheral nerve blocks for analgesia with general anaesthesia.
2. patients with head injury
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome variable for this study is the incidence of rebound pain in Trauma patients undergoing surgery under regional block.  on arrival, post operative 30 min, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1. severity (amplitude) of the Rebound pain
2. Risk factors for rebound pain like demographic factor, type of block, duration and nature of surgery 
on arrival, post operative 30 min, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   26/06/2024 
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="1"
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  

This single-centre prospective cohort study will be conducted at   Advanced Trauma Centre located at Post Graduate Institute of Medical education and research Chandigarh, India. 

The preoperative assessment of pain at rest and pain during the previous 24 hrs at the operative site will be assessed using a numeric rating scale (NRS) from 0 to 10 (where 0.no pain and 10 worst possible pain) In the operating room, procedure will be performed by treating anaesthesiologist as per institute protocol with dexamethasone 4mg as additive to volume of drug given for block. Patients will be followed up for 24 hrs after surgery. Age, gender, BMI, baseline pain scores and ASA physical status will be included as patient factors. Surgical site and involvement of bone (e.g. debridement, fixation, amputation, tendon repair) will be included as surgical factors. Local anaesthetic type and dose, type of PNB, use of additive will be included as anaesthetic factors. Type of PNB will be grouped as brachial plexus block (axillary, supraclavicular, or infraclavicular block), interscalene block (ISB), sciatic nerve block (subgluteal and popliteal blocks), and distal PNBs (e.g. ankle and wrist blocks). Pain scores in the PACU and post-discharge use of acetaminophen and NSAIDS will be included as postoperative factors. Durations of motor block and sensory block will be calculated from block time to when the patients reported motor and sensory resolution of the block, respectively. We will exclude patients who received peripheral nerve blocks for analgesia with general anaesthesia.


 
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