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CTRI Number  CTRI/2018/02/012137 [Registered on: 23/02/2018] Trial Registered Retrospectively
Last Modified On: 23/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To see whether adding a drug (dexmedetomidine)to the nerve block, provides longer period of pain relief after hip operation.  
Scientific Title of Study   Efficacy of Dexmedetomidine as an adjuvant in femoral nerve block for post-op pain relief in hip surgery: A randomized control double blind study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHETNA GOEL 
Designation  Junior Resident 
Affiliation  SDM College Of Medical Science And Hospitals 
Address  Department Of Anaesthesia, SDM College of Medical Science And Hospitals , Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9980615489  
Fax    
Email  chetnaseventeen@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SAMEER DESAI 
Designation  Associate Professor 
Affiliation  SDM College Of Medical Science And Hospitals 
Address  Department Of Anaesthesia, SDM College of Medical Science And Hospitals , Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  02477755  
Fax    
Email  sameeranaes@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SAMEER DESAI 
Designation  Associate Professor 
Affiliation  SDM College Of Medical Science And Hospitals 
Address  Department Of Anaesthesia, SDM College of Medical Science And Hospitals , Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  02477755  
Fax    
Email  sameeranaes@gmail.com  
 
Source of Monetary or Material Support  
SDM College of Medical Science And Hospitals , Dharwad 
 
Primary Sponsor  
Name  SDM College of Medical Science And Hospitals 
Address  Department Of Anaesthesia, SDM College of Medical Science And Hospitals , Dharwad 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
CHETNA GOEL  Department Of Anaesthesia, SDM College of Medical Science And Hospitals , Dharwad, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
CHETNA GOEL  Operation Theatre, 2nd Floor, SDM College of Medical Science And Hospitals  Operation Theatre, 2nd floor, SDM College of Medical Science And Hospitals , Dharwad, India
Dharwad
KARNATAKA 
9980615489

chetnaseventeen@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patient with hip fracture,undergoing operation.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A  USG guided femoral nerve block with 40ml [ 0.25% bupivacaine + 0.5ml NS) in affected lower limb and 0.5 ml NS intramuscularly in opposite side gluteal area. 
Intervention  Group B  USG guided femoral nerve block with 40ml [0.25% bupivacaine + 50 mcg dexmedetomidine (0.5ml)] in affected lower limb and 0.5 ml NS intramuscularly in opposite gluteal area. 
Intervention  Group C  USG guided femoral nerve block with 40ml [ 0.25% bupivacaine + 0.5ml of NS] in affected lower limb and 0.5 ml of 50 mcg dexmedetomidine intramuscularly in the opposite gluteal area 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age group: 18-80y.
Belonging to ASA I, II and III.
Scheduled to undergo surgery for hip surgery
 
 
ExclusionCriteria 
Details  Patient with :
Poly trauma
Head injury
known cases of bleeding disorders,neuromuscular abnormalities
Deformities of the lumbar region.
Parents not willing to give consent for the study.
Chronic alcoholic and long term steroid therapy.
Consuming analgesics and adrenergic agonist or antagonist for a long time.
Patient not giving consent for regional anaesthesia
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of first rescue analgesia after block  Every 4th hours till analgesic requirement 
 
Secondary Outcome  
Outcome  TimePoints 
24hour analgesic requirement   Everly 4th hourly till 24 th hour. 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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 4 
Date of First Enrollment (India)   01/11/2016 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   1.1. Beaudoin FL, Nagdev A, Merchant RC et al. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010;28:76-81. 2.. YaDeau JT, LaSala VR, Paroli L, et al. Clonidine and analgesic duration after popliteal fossa nerve blockade: randomized double blind, placebo-controlled study. Anesth Analg. 2008:106:1916-20. 3.Abdallah FW, Brull R. Facilitatory effect of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systemic review and meta –analysis .Br J Anaesth 2013;110:915-25. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary              

Background: Dexmeditomidine is a useful as additive to local anaesthetics in peripheral nerve block but whether it acts locally or after systemic absorption in not clear.

            The aim of present study is to assess whether addition of dexmeditomidine prolongs duration of post-operative analgesia, when used along with local anaesthetics for USG guided Femoral nerve block and to test dexmeditomidine acting locally at peripheral nerve block or act after systemic absorption. The study is intended to compare the extent and quality of post-operative analgesia by ultrasound (USG) guided Femoral Nerve Block (FNB) with dexmeditomidine 50 mcg as an additive to 0.25% bupivacaine in affected limb in one (group B) , or USG guided femoral block with only local anaesthetic along with Intramuscular Dexmedetomidine 50 mcg  in opposite limb in other group.

 

Methodology:  The study is a prospective, double blind randomized clinical trial, approved from ethical committee and RGUHS

 The study includes patients undergoing hip surgery with following inclusion criteria 1). Age 18-80 years 2.) ASA  Physical status- I,II and III 4.) patient giving consent, Excluding patients with 1.)Polytrauma 2,)bleeding disorders and head injury 3.)Deformities of lumbar region 5.)Chronic alcoholic 6.)Patient on long term steroid  and alpha agoinst use 6.)Patient not giving consent for regional anaesthesia.

                       All the patients will be preoperatively evaluated, optimized and necessary investigations will be carried out as per the need. They will be kept nil orally for 8 h before surgery and pre-medicated with oral alprazolam 0.25 mg and ranitidine 150 mg the night before surgery. In the operation theatre, after securing IV-line with18-gauge intravenous (IV) cannula, IV fluids will be started. The patients will be given SAB in sitting position using 26 G Quincke spinal needle at L3–L4 interspace with 12- 14 mg (2.4-2.8 mL) 0.5% hyperbaric bupivacaine after ensuring free flow of cerebrospinal fluid. After confirmation of adequate level, surgery will be allowed to proceed. Patients will not receive any additional analgesic in intraoperative period while anxious patients will be given intravenous midazolam 1 mg.  

At the end of surgery, once spinal level recedes to T 12 level, USG-guided FNB will be given.

                  Patient selected as per inclusion criteria will randomized into either of the three groups using closed envelope technique into following group:

 Group A: USG guided FNB with 40 ml (0.25 % bupivacaine +0.5 ml of NS) in affected lower limb and 0.5 ml NS as Intramuscular injection in opposite gluteal region.

 Group B: USG guided FNB with 40 ml (0.25% bupivacaine + 50 mcg of dexmeditomidine) in affected limb and 0.5 ml NS as Intramuscular injection in opposite gluteal region

Group C: USG guided FNB with 40 cc (0.25 % bupivacaine) in affected limb and 50 mcg of dexmedetomidine as Intramuscular injection in opposite gluteal region

 Blinding: Double bling, closed enveloped technique.

Following block, patients will be monitored in the post anaesthesia care unit (PACU) for two hours. Patient will be assessed every hourly in postoperative room and every 4th hourly, in the ward, till patient complains of pain with VAS score >3, intravenous Inj tramadol 50 mg will be given as rescue analgesia and analgesic requirement for next 24 hours will be assessed. If patient complains of nausea or vomiting, Inj ondansetron 4 mg will be given and . If Ramsay sedation score > 5, patient will be supplemented with oxygen via oxygen mask and monitored. If patient develop bradycardia HR <45, injection Atropine 0.6 mg i/v stat can be given and continued monitoring.

Primary outcome: Duration of analgesia after the block.

Secondary outcome: Total analgesic requirement in 24-hour, side effect.

Sample size :75

  • Statistics analysis: Data will be analysed by rates, ratios, percentages and proportions.

  • Chi-square test will be done for categorical data and one-way ANOVA for continuous data.

  • Data will be analysed using SPSS software

P < 0.05 will be considered to be statistically significant.

Background: Dexmeditomidine is a useful as additive to local anaesthetics in peripheral nerve block but whether it acts locally or after systemic absorption in not clear.

            The aim of present study is to assess whether addition of dexmeditomidine prolongs duration of post-operative analgesia, when used along with local anaesthetics for USG guided Femoral nerve block and to test dexmeditomidine acting locally at peripheral nerve block or act after systemic absorption. The study is intended to compare the extent and quality of post-operative analgesia by ultrasound (USG) guided Femoral Nerve Block (FNB) with dexmeditomidine 50 mcg as an additive to 0.25% bupivacaine in affected limb in one (group B) , or USG guided femoral block with only local anaesthetic along with Intramuscular Dexmedetomidine 50 mcg  in opposite limb in other group.

 

Methodology:  The study is a prospective, double blind randomized clinical trial, approved from ethical committee and RGUHS

 The study includes patients undergoing hip surgery with following inclusion criteria 1). Age 18-80 years 2.) ASA  Physical status- I,II and III 4.) patient giving consent, Excluding patients with 1.)Polytrauma 2,)bleeding disorders and head injury 3.)Deformities of lumbar region 5.)Chronic alcoholic 6.)Patient on long term steroid  and alpha agoinst use 6.)Patient not giving consent for regional anaesthesia.

                       All the patients will be preoperatively evaluated, optimized and necessary investigations will be carried out as per the need. They will be kept nil orally for 8 h before surgery and pre-medicated with oral alprazolam 0.25 mg and ranitidine 150 mg the night before surgery. In the operation theatre, after securing IV-line with18-gauge intravenous (IV) cannula, IV fluids will be started. The patients will be given SAB in sitting position using 26 G Quincke spinal needle at L3–L4 interspace with 12- 14 mg (2.4-2.8 mL) 0.5% hyperbaric bupivacaine after ensuring free flow of cerebrospinal fluid. After confirmation of adequate level, surgery will be allowed to proceed. Patients will not receive any additional analgesic in intraoperative period while anxious patients will be given intravenous midazolam 1 mg.  

At the end of surgery, once spinal level recedes to T 12 level, USG-guided FNB will be given.

                  Patient selected as per inclusion criteria will randomized into either of the three groups using closed envelope technique into following group:

 Group A: USG guided FNB with 40 ml (0.25 % bupivacaine +0.5 ml of NS) in affected lower limb and 0.5 ml NS as Intramuscular injection in opposite gluteal region.

 Group B: USG guided FNB with 40 ml (0.25% bupivacaine + 50 mcg of dexmeditomidine) in affected limb and 0.5 ml NS as Intramuscular injection in opposite gluteal region

Group C: USG guided FNB with 40 cc (0.25 % bupivacaine) in affected limb and 50 mcg of dexmedetomidine as Intramuscular injection in opposite gluteal region

 Blinding: Double bling, closed enveloped technique.

Following block, patients will be monitored in the post anaesthesia care unit (PACU) for two hours. Patient will be assessed every hourly in postoperative room and every 4th hourly, in the ward, till patient complains of pain with VAS score >3, intravenous Inj tramadol 50 mg will be given as rescue analgesia and analgesic requirement for next 24 hours will be assessed. If patient complains of nausea or vomiting, Inj ondansetron 4 mg will be given and . If Ramsay sedation score > 5, patient will be supplemented with oxygen via oxygen mask and monitored. If patient develop bradycardia HR <45, injection Atropine 0.6 mg i/v stat can be given and continued monitoring.

Primary outcome: Duration of analgesia after the block.

Secondary outcome: Total analgesic requirement in 24-hour, side effect.

Sample size :75

  • Statistics analysis: Data will be analysed by rates, ratios, percentages and proportions.

  • Chi-square test will be done for categorical data and one-way ANOVA for continuous data.

  • Data will be analysed using SPSS software

P < 0.05 will be considered to be statistically significant.
 
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