| CTRI Number |
CTRI/2024/04/065862 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of combining superficial cervical plexus block with clavipectoral fascial plane block or interscalene brachial plexus block using ultrasound machine with local anesthesia 0.375% ropivacaine for collar bone fracture surgeries |
|
Scientific Title of Study
|
A Prospective Randomized Controlled Comparative Study of Combining Ultrasound Guided Superficial Cervical Plexus Block with Clavipectoral Fascial plane Block and Interscalene Brachial Plexus Block using 0.375% Ropivacaine for Elective Clavicle Surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Muni Sruthi |
| Designation |
Post Graduate First Year |
| Affiliation |
Navodaya Medical College Hospital and Research Centre |
| Address |
Department of Anesthesiology,
Navodaya Medical College, Hospital and Research Centre,
Raichur 584103
Raichur KARNATAKA 584103 India |
| Phone |
8374521228 |
| Fax |
|
| Email |
sruthikota86@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Gowni Geetha |
| Designation |
Associate Professor |
| Affiliation |
Navodaya Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesiology,
Navodaya Medical College, Hospital and Research Centre,
Raichur 584103
Raichur KARNATAKA 584103 India |
| Phone |
9353116870 |
| Fax |
|
| Email |
kumargowtham1994@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gowni Geetha |
| Designation |
Associate Professor |
| Affiliation |
Navodaya Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesiology,
Navodaya Medical College, Hospital and Research Centre,
Raichur 584103
Raichur KARNATAKA 584103 India |
| Phone |
9353116870 |
| Fax |
|
| Email |
kumargowtham1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Navodaya Medical College Hospital and Research Centre,
Raichur 584103 |
|
|
Primary Sponsor
|
| Name |
K MUNI SRUTHI |
| Address |
Department of Anesthesiology,
Navodaya Medical College, Hospital and Research Centre,
Raichur 584103 |
| Type of Sponsor |
Other [Self] |
|
|
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 K Muni Sruthi |
Navodaya Medical College Hospital and Research Centre |
Operation theatre,
Department of Anesthesiology,
Navodaya Medical College, Hospital and Research Centre,
Raichur 584103 Raichur KARNATAKA |
8374521228
sruthikota86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee (IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S420||Fracture of clavicle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Superficial cervical plexus block with clavipectoral fascial plane block using 0.375% Ropivacaine |
Superficial cervical plexus block with 7ml of 0.375% Ropivacaine Clavipectoral fascial plane block with 10 ml of 0.375% Ropivacaine on either side of fracture
Maximum dose of Ropivacaine being 3mg/kg.
Route of administration is Ultrasound guided administration of local anaesthetic agents around the nerve |
| Intervention |
Superficial cervical plexus block with Interscalene brachial plexus block |
Superficial cervical plexus block with 7ml of 0.375% Ropivacaine Interscalene brachial plexus block with 20 ml of 0.375% Ropivacaine Maximum dose of Ropivacaine being 3mg/kg
Route of administration is Ultrasound guided administration of local anaesthetic agents around the nerve |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients belonging to American Society of Anaesthesiologists Physical Status I and II.
2. Patients undergoing elective surgery for clavicle fractures. |
|
| ExclusionCriteria |
| Details |
1. Patients refusing for the procedure.
2. Patients with history of allergy, sensitivity or any kind of reactions to
local anesthetic agents.
3. Patients with coagulation abnormalities.
4. Patients with cardiovascular and cerebrovascular diseases.
5. Patients with infection at the injection site.
6. Patients with history of Chronic Obstructive Pulmonary Disease and
Pleural effusion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
The time at which the first use of rescue analgesic drug.
This will be assessed in the postoperative period after the surgery. |
Pain will be assessed using Pain Score : Visual Analogue Scale at 6th , 12th and 24th hour postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The sensory effect of all the blocks will be assessed in three areas:
sternoclavicular joint,
mid clavicle, acromioclavicular joint preoperatively after giving block. |
The sensation will be assessed
immediately after giving block & also at 30th minute after giving block to check for the onset time. |
| The motor effect of all the blocks will be assessed preoperatively after giving block at shoulder joint, elbow joint, wrist joint, metacarpophalangeal & interphalangeal joints of fingers |
The motor effect will be assessed
immediately after giving block & also at 30th minute after giving block to check for the onset time. |
Diaphragm excursion measurement will be done during normal tidal volume breaths & deep breaths before giving
block preoperatively & also intraoperatively & also postoperatively |
Diaphragm excursion measurement will be assessed using Ultrasound in centimeters just before giving block as preblock value & at 30th minute after giving block & also at 4th hour after giving block |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/05/2024 |
| Date of Study Completion (India) |
25/12/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The aim of my study is to compare the application of Ultrasound guided superficial cervical plexus block combined with clavipectoral fascial plane block or interscalene brachial plexus block in elective clavicle fractures using 0.375% Ropivacaine with respect to duration of analgesia and incidence of hemidiaphragmatic paresis or paralysis. As institutional ethical committee approval obtained, written and informed consent will be taken from the patient. The study will be conducted in 100 patients between 18 to 60 years of age, ASA-I and ASA-II of either gender with fracture of clavicle electively posted for open reduction and internal fixation Patients will be randomly allocated into one of the following groups Group I and Group II using computer generated random number table Group I: Patients in this group will receive superficial cervical plexus block with 7 ml of 0.375% Ropivacaine and clavipectoral fascial plane block with 20 ml of 0.375% of Ropivacaine under ultrasound guidance Group II: Patients in this group will receive superficial cervical plexus block with 7 ml of 0.375% Ropivacaine and interscalene brachial plexus block using 20 ml of 0.375% ropivacaine under ultrasound guidance All the patients in the study will be subjected to a thorough pre-anaesthetic evaluation which includes a detailed history taking, complete general physical examination and necessary relevant investigations like complete blood count, blood urea, serum creatinine, chest X-ray, ECG, bleeding time, clotting time. All the patients will be kept nil per oral 8-10 hours for solids and 2 hours for clear fluids. Tablet Alprazolam 0.5 mg and Tablet Pantoprazole 40 mg will be given on the night before surgery. And, at 6 AM on the day of surgery, Injection Pantoprazole 40 mg will be given intravenously. For administration of fluids and drugs, 18G intravenous line will be secured. The patient will be shifted to pre-operative room and multiparameter monitor will be connected and intravenous fluids will be connected and pre-operative heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, oxygen saturation, ECG and Diaphragm excursion movement using Ultrasound will be recorded. The superficial cervical plexus block and clavipectoral fascial plane block using 0.375% ropivacaine for Group A patients and superficial cervical plexus block and interscalene brachial plexus block using 0.375% ropivacaine for Group B patients will be given under ultrasound guidance
ULTRASOUND GUIDED SUPERFICIAL CERVICAL PLEXUS BLOCK: The patient will be placed in a supine position with the head turned to the opposite side of fracture for adequate exposure of the neck and the upper chest. Under strict aseptic precautions, A high-frequency linear ultrasound probe will be placed at the lateral aspect of neck at the level of cricoid cartilage, Once the sternocleidomastoid muscle is identifed, the probe will be moved posteriorly until the posterior tapering end of the muscle is identified. Then, the superficial cervical plexus (SCP) and investing layer of deep cervical fascia will be visualized and 26 Gauge 1.5 inch needle will be introduced by in-plane technique until its tip reaches near the superficial cervical plexus. After careful negative aspiration to exclude intravascular placement, 7 mL of 0.375% ropivacaine will be deposited.
ULTRASOUND GUIDED CLAVIPECTORAL FASCIAL PLANE BLOCK: The patient will be placed in a supine position with the head turned to the opposite side of the fracture and the shoulder will be padded with a small pillow. Under strict aseptic precautions, A high frequency linear probe will be placed on either side of fractured site on anterior surface of the clavicle and 26 Gauge 1.5 inch needle will be introduced by in-plane technique from caudal to cephalad direction until its tip reaches between periosteum of clavicle and clavipectoral fascia. After careful negative aspiration to exclude intravascular placement, 10 mL of 0.375% ropivacaine will be deposited on either side of fracture site.
ULTRASOUND GUIDED INTERSCALENE BRACHIAL PLEXUS BLOCK: The patient will be placed in a supine position with the head turned to the opposite side of the fracture and the shoulder will be padded with a small pillow. Under strict aseptic precautions, a high frequency linear probe will be placed at the level of cricoid cartilage to visualize the roots of brachial plexus located between the anterior and middle scalene muscles and 26 Gauge 1.5 inch needle will be introduced by in-plane technique to reach near C5 and C6 nerve roots. After careful negative aspiration to exclude intravascular placement, 20 mL of 0.375% ropivacaine will be deposited to achieve its spread between C5 and C6 nerve roots.
The sensory block, motor block and analgesic duration is assessed using the scales as entered previously in our Part 7 of Trail Registration steps. The diaphragm excursion movement will be assessed using ultrasound during normal tidal volume breaths and deep breaths before giving block and 30th minute and 4th hour after giving the block in both the groups and the incidence of hemi-diaphragmatic paresis or paralysis is assesed
DIAPHRAGM EXCURSION MOVEMENT: Patient will be placed in a supine position. By using low frequency curvilinear probe of ultrasound the diaphragm will be focussed by keeping it longitudinal at the level of anterior axillary line in subcostal region. Then Motion mode (M-Mode) of the diaphragm is used to detect diaphragmatic excursion along a line selected perpendicular to the diaphragm. Two representative images of diaphragmatic excursion will be saved during tidal volume breath and deep breath respectively. The excursion amplitude will be measured as upright perpendicular distance from minimum to maximum point of diaphragmatic excursion. Diaphragm excursion measurement will be done before giving block as preblock value and after giving block at 30th minute and 4th hour. Hemidiaphragmatic paralysis is defined as more than 50% reduction in diaphragmatic excursion compared with preblock value during deep breaths and/or Paradoxical movements of diaphragm after 30 minutes of giving block |