| CTRI Number |
CTRI/2024/05/067005 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| 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 stellate ganglion block with interscalene brachial plexus block for post operative pain relief in patients undergoing surgeries of upper limb |
|
Scientific Title of Study
|
Stellate Ganglion Block vs Interscalene Brachial Plexus Block for postoperative analgesia among patients undergoing upper limb surgeries: randomized clinical trial. |
| Trial Acronym |
NL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhilash Sharma |
| Designation |
Junior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, 4th floor, A block, Nehru hospital,
PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
8448763286 |
| Fax |
|
| Email |
abhilash94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Karan Singla |
| Designation |
Assistant professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, 4th floor, A block, Nehru Hospital
PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9592919073 |
| Fax |
|
| Email |
karansingla16@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Karan Singla |
| Designation |
Assistant professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, 4th floor, A block , Nehru hospital
PGIMER, sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9592919073 |
| Fax |
|
| Email |
karansingla16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, 4th floor, A block, Nehru Hospital, PGIMER, sector 12, chandigarh, India, 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, 4th floor, A block, Nehru hospital, PGIMER, Sector 12, Chandigarh, India. 160012 |
| 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 Karan Singla |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh |
Operation Theatre Complex, 3rd floor, Department of Anaesthesia and Intensive Care, Advanced Trauma Centre, PGIMER, Chandigarh. 160012 Chandigarh CHANDIGARH |
9592919073
karansingla16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S423||Fracture of shaft of humerus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
interscalene brachial plexus nerve block |
patients with upper limb fractures will be administered interscalene brachial plexus nerve block for analgesia. Post-operative pain scores using the Numerical rating Scale will be recorded at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours post operatively. |
| Intervention |
stellate ganglion block |
patients with upper limb fractures will be administered stellate ganglion block for post operative analgesia. patients will be observed for post operative pain at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours post operatively using the Numerical rating Scale |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA physical status 1–2, aged between 18 and 60 years with an upper limb fracture scheduled for surgery under general anaesthesia. We will include patients with humerus shaft fractures, humerus surgical neck fractures and humeral supracondylar fractures, where open surgery is indicated. |
|
| ExclusionCriteria |
| Details |
BMI more than 30 kg/m2, history of substance abuse, Inability to understand a pain scale (VAS, NRS), Allergy to lignocaine , Chronic sympathetic-mediated pain syndromes affecting the upper limb, Trauma other than to the affected limb, Severe congestive heart failure , Severe Chronic obstructive pulmonary disease (COPD)
|
|
|
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 compare the efficacy of preoperative stellate ganglion block with interscalene brachial plexus block among patients undergoing upper limb surgeries as a difference in NRS of 2. |
0,6,12,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the incidence of adverse effects in each of the two groups, To determine time to administration of first rescue analgesic, To find the total dose of tramadol consumption in first 48 hours post operatively
|
0,6,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
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)
|
20/05/2024 |
| 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 Applicable |
| 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
|
Patients will be evaluated before surgery to assess their fitness for the proposed surgical procedure under general anaesthesia, and written informed consent will be obtained at this stage. Patients will be instructed on the pain NRS scorebefore surgery, and will be reminded before transfer to the operating theatre and in the post- anaesthesia care unit. All patients will be fasted for 8 h pre-operatively and premedicated with oral alprazolam 0.25 mg and ranitidine 150 mg the night before and 2 h before surgery. In the operating theatre, mandatory monitoring including NIBP (Non-Invasive Blood Pressure), heart rate, continuous ECG, oxygen saturation and end-tidal carbon dioxide will be placed. Intravenous access will be established and patients receive 500 ml saline 0.9% and midazolam 1–2 mg. Stellate ganglion block (SGB group) will be performed under ultrasound guidance using the para-tracheal, out-of-plane technique. Doppler imaging will be used to rule out any aberrant vessels along the plane of needle placement. Three millilitres of lignocaine 2% will be injected at the level of the C7 vertebra underneath the fascia of the longus colli muscle. Correct localisation of the injection will be demonstrated by expansion of the fascia over the muscle. Interscalene block (IBPB group)- The block will be performed under sterile conditions. Using a high-frequency linear ultrasound transducer. The cervical roots and interscalene muscles will be identified. The anaesthesiologist will insert a 22 gauge. 80 mm nerve stimulating needle lateral to medial, with an in-plane technique into the interscalene groove. Once the tip of the needle was positioned in between the C5 and C6 nerve roots, 20 ml of 0.125% bupivacaine would be injected in incremental doses with intermittent aspiration Patients in both groups will be observed for any possible adverse effects of the block such as Horner’s syndrome, motor or sensory blockade of the upper limb, recurrent laryngeal nerve or phrenic nerve block or any other effects for 10 min before induction of general anaesthesia. General anaesthesia was induced with intravenous fentanyl 2 mcg/kg and propofol 2–3 mg/kg, and vecuronium 0.1 mg/kg will be administered to provide muscle paralysis. After tracheal intubation, anaesthesia will be maintained with nitrous oxide:oxygen 60:40 and isoflurane 1–2%, and intermittent boluses of vecuronium will be administered as required. Twenty minutes before the end of surgery, Tramadol 1 mg/kg and ondansetron 0.1 mg/kg will be administered intravenously. At the end of surgery, residual neuromuscular blockade will be reversed with intravenous neostigmine 50 mcg/kg plus glycopyrrolate 10 mcg/kg. Routine postoperative analgesia includes intravenous paracetamol 1 g every 6 h and intra- venous diclofenac 75 mg every 12 hourly. Postoperative measurements will be made at 0, 2, 4, 6, 8, 12, 24 and 48 hours postoperatively consisting of pain scores as measured by Numerical Rating scale (NRS) at rest and at movement. If NRS was >4, rescue analgesia in the form of Tramadol 75 mg IV with ondansetron 4 mg will be administered. At every time point, Tramadol consumption, cardiovascular variables, sedation, nausea, vomiting, and any adverse effects like respiratory failure, hematoma will be recorded. |