| 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
|
|
|
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
|
|
|
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.
|