| CTRI Number |
CTRI/2024/05/067541 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To determine the effectiveness combination of T12 paravertebral,lumbar plexus and sacral plexus blocks in hip surgeries. |
|
Scientific Title of Study
|
A prospective observational study to determine the effectiveness of USG and PNS guided combination of T12 paravertebral,lumbar plexus and sacral plexus blocks in high risk patients undergoing hip 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 |
Dr Mithranmajan G |
| Designation |
Junior resident,Anaesthesia |
| Affiliation |
Government medical college,Surat |
| Address |
Department of Anaesthesia,2nd floor,Old college building,,Government medical college and New civil hospital Surat,Ring Road , Opp stem Cell Hospital,Khatodara Wadi,Majura Gate ,Surat,Gujarat
Surat GUJARAT 395001 India |
| Phone |
9656436524 |
| Fax |
|
| Email |
mithranmajan1996@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bansari N Kantharia |
| Designation |
Additional Professor,Anaesthesia |
| Affiliation |
Government medical college,Surat |
| Address |
Department of Anaesthesia,2nd floor,Old college building,,Government medical college and New civil hospital Surat,Ring Road , Opp stem Cell Hospital,Khatodara Wadi,Majura Gate ,Surat,Gujarat
Surat GUJARAT 395001 India |
| Phone |
9825690177 |
| Fax |
|
| Email |
bansarikantharia@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bansari N Kantharia |
| Designation |
Additional Professor,Anaesthesia |
| Affiliation |
Government medical college,Surat |
| Address |
Department of Anaesthesia,2nd floor,Old college building,,Government medical college and New civil hospital Surat,Ring Road , Opp stem Cell Hospital,Khatodara Wadi,Majura Gate ,Surat,Gujarat
Surat GUJARAT 395001 India |
| Phone |
9825690177 |
| Fax |
|
| Email |
bansarikantharia@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and New civil hospital surat |
|
|
Primary Sponsor
|
| Name |
Government medical College and new civil hospital surat |
| Address |
Government medical College and new civil hospital surat,near majura gate |
| Type of Sponsor |
Government medical college |
|
|
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 Mithranmajan G |
Government medical College and new civil hospital surat |
Orthopaedic operation theatre,1st floor,Department of Anaesthesiology,Government medical College and new civil hospital surat,near majura gate surat Surat
GUJARAT Surat GUJARAT |
9656436524
mithranmajan1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human research ethics committee GMC SURAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for hip orthopaedic surgeries
receiving T12 paravertebral block along with combined lumbar and sacral plexus.
Patients belonging to ASA grade 3/4
Patients giving written informed consent |
|
| ExclusionCriteria |
| Details |
1.neuromuscular disease and established peripheral neuropathy 2.Skin infection at the site of needle insertion.
3.Chronic pain syndromes or receiving chronic analgesic therapy 4.Patients with reported history of allergy to any of the study drugs.
5.Patients having multiple fractures or having bilateral fractures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe ,
Time required to perform the block
Onset and duration of motor and sensory block
Quality of the block. |
To observe ,
Time required to perform the block
Sensory evaluation will be done by pin prick with a 23 G needle an interval of 5,10,15,20,25 and 30 minutes.
Motor block will be assessed at an interval of the 5, 10, 15, 20,
25 and 30 minutes. Motor block is graded on modified bromage scale
Quality of the block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of postoperative analgesia & analgesic requirement in first 24hrs
Hemodynamic changes
Complications /adverse effect. |
At 2-hour, 4-hour, 8-hour, 12 hour & 24 hours after block. |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/05/2024 |
| 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
|
Regional anesthesia is the most commonly used method of anesthesia for lower limb surgeries and the most common mode of regional anesthesia used is neuraxial anesthesia (spinal/epidural). The benefits of using regional anesthesia in hip fracture surgeries as compared to the use of general anesthesia are significant reduction in the number of complications like the airway instrumentation and manipulation, venous thromboembolism, respiratory complications ,also has advantage of early resumption of oral intake postoperatively. Neuraxial anesthesia has several disadvantages like perioperative hemodynamic instability, urinary retention, epidural hematoma etc which can lead to undesirable events like myocardial infarction, stroke and CNS infection in high-risk surgical patients and patients on anticoagulant or antiplatelet medications which possess higher risk of postoperative morbidity and mortality. Peripheral nerve blocks which block one or more Peripheral nerves that supply the surgical field in the operative limb are an effective method for lower limb surgeries.Newer techniques that is ultrasound-guided nerve blocks with nerve stimulator increase the success rate and reduce risks such as nerve injuries, hematomas and renal puncture.They also provide postoperative pain relief with improved patient satisfaction, stable hemodynamics, early ambulation thereby reducing the length of hospital stay. The upper dermatome level of sensory block to T10 is recommended for hip surgery with spinal anesthesia. Recent studies show a dermatome level up to T12 may satisfy the requirement of surgical anesthesia for hip replacement. The nerves innervating the hip joints arise from the ventral rami of the spinal nerve roots of the lower part of the lumbar plexus (L2-4) and the upper part of the sacral plexus (L4-S1). The lateral femoral cutaneous nerve from the lumbar plexus (L2-L3), lateral cutaneous branch of iliohypogastric nerve (T12 and L1) and subcostal nerve (T12 thoracic nerve) innervate the area of the superior lateral gluteal region and the proximal lateral thigh that are involved in skin incision of posterolateral approach to hip joint . Lumbar plexus block results in blockade of the femoral nerve, lateral femoral cutaneous nerve and the obturator nerve while the sacral plexus block results in blockade of the sciatic nerve, posterior cutaneous nerve of thigh, superior and inferior gluteal nerves, pudendal nerve, pelvic splanchnic nerve, inferior hypo- gastric plexus and the terminal portion of sympathetic trunk. lumbar plexus and sacral plexus block do not provide enough sensory block in L1 and T12 dermatome which is required for consistent surgical anesthesia for hip surgery. To overcome this supplemental dosage of propofol and opioids, infiltration at incision and iliac crest point block are required. However, these techniques are not reliable, and conversion to general anesthesia is often required. An ultrasound guided T12 Paravertebral block (PVB) provide sensory block of subcostal nerve and iliohypogastric nerve, it also blocks the superior gluteal cutaneous nerve derived from posterior branch of L1 and L2 spinal nerves through a paravertebral space spread. This T12 PVB is safe, effective and simple, and will produce sensory blockade covering the surgical incision to the level above the great trochanter on the superior lateral gluteal region. So far no study has done at our institution to determine the effectiveness of USG and PNS guided combination of these 3 blocks.So I would like to carry out this observational study. |