FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/03/006712 [Registered on: 07/03/2016] Trial Registered Prospectively
Last Modified On: 07/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of a drug named dexmedetomidine with local anaesthesia drug for middle thigh block in patients undergoing knee ligament surgeries and its effect on requirement of post operative pain relieving drug. 
Scientific Title of Study   Evaluation of analgesic efficacy of dexmedetomidine as adjuvant with ropivacaine in adductor canal block(ACB). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Thapa 
Designation  Associate Professor 
Affiliation  Govt Medical College And Hospital 
Address  Department of Anaesthesia Govt Medical College And Hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121524  
Fax    
Email  dpkthapa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Khushboo Pandey 
Designation  Postgraduate Resident 
Affiliation  Govt Medical College And Hospital 
Address  Department of Anaesthesia Govt Medical College And Hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9888530182  
Fax    
Email  khushboo0411@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Thapa 
Designation  Associate Professor 
Affiliation  Govt Medical College And Hospital 
Address  Department of Anaesthesia Govt Medical College And Hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121524  
Fax    
Email  dpkthapa@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Govt Medical College And Hospital Sector 32 Chandigarh 
 
Primary Sponsor  
Name  Govt Medical College And Hospital 
Address  Govt Medical College And Hospital Sector 32 Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Thapa  Govt Medical College and Hospital   Post Anaesthesia Care Unit, Level 3 Operation Theatre, C-Block, Govt Medical College and Hospital Sector 32 Chandigarh
Chandigarh
CHANDIGARH 		 9646121524

dpkthapa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients undergoing knee ligament reconstruction surgeries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group I- Patients will receive adductor canal block (ACB) with 17 ml of a solution ( 15 ml of 0.5% ropivacaine plus 2ml of sterile normal saline to make a final volume of 17ml) and 10ml of sterile normal saline by IV route.  Patients will receive ACB with 17 ml of a solution ( 15 ml of 0.5% ropivacaine plus 2ml of sterile normal saline to make a final volume of 17ml) and 10ml of sterile normal saline by IV route. 
Comparator Agent  Group II- Patients will receive ACB with 17ml of a solution (15ml of 0.5% ropivacaine plus 0.5 µg.kgˉ1 of dexmedetomidine plus normal saline to make a final volume of 17ml) and 10 ml of sterile normal saline by IV route.  Patients will receive ACB with 17ml of a solution (15ml of 0.5% ropivacaine plus 0.5 µg.kgˉ1 of dexmedetomidine plus normal saline to make a final volume of 17ml) and 10 ml of sterile normal saline by IV route. 
Comparator Agent  Group III- Patients will receive ACB with 17ml of a solution (15ml of 0.5% ropivacaine plus 2ml of sterile normal saline to make a final volume of 17 ml) and 0.5 µg.kgˉ1 of dexmedetomidine diluted in sterile normal saline to make a final volume of 10ml by IV route.   Patients will receive ACB with 17ml of a solution (15ml of 0.5% ropivacaine plus 2ml of sterile normal saline to make a final volume of 17 ml) and 0.5 µg.kgˉ1 of dexmedetomidine diluted in sterile normal saline to make a final volume of 10ml by IV route.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA physical status I and II of either sex
2. Age between 18 to 60 years
3. BMI ≥ 20 to ≤ 30 kg m-2
4. Scheduled for ACL reconstruction surgery.
 
 
ExclusionCriteria 
Details  1. Patients having history of substance abuse.
2. Patients with coagulopathy and bleeding disorders.
3. Preexisting peripheral neuropathy.
4. Preexisting local infection at the site of block.
5. Pregnant and lactating women.
6. Inability to understand functioning of PCA pump and VAS (Visual Analogue Scale).
7. Contraindication to study drugs ropivacaine, dexmedetomidine and morphine.
8. Patients having haemodynamic instability, hypotension, bradycardia, hepatic dysfunction.
9. Patients on regular chronic pain management drugs for the last three months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study morphine sparing effect of dexmedetomidine as adjuvant to ropivacaine in ultrasound guided ACB following arthroscopic ACL reconstruction surgery.  To study cumulative morphine consumption at 24 hours. Morphine consumption will be monitored at 0,2,4,6,8,12 and 24 hours interval. 
 
Secondary Outcome  
Outcome  TimePoints 
To study postoperative pain relief, haemodynamics and adverse effects after ultrasound guided ACB following arthroscopic ACL reconstruction surgery.  Preoperatively (baseline),immediately after block 0, 5, 10, 15, 20, 30, 60 minutes and followed by 2, 4, 6, 8, 12 and 24 hours interval.  
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   10/03/2016 
Date of Study Completion (India) 10/02/2018 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Regional nerve blocks provide longer duration of analgesia and are efficient in preventing sensitization of the central and peripheral nervous system, which may prevent the development of chronic pain. Patients after arthroscopic ACL reconstruction experience moderate to severe pain in the postoperative period. There are various modalities for postoperative pain control after arthroscopic ACL reconstruction such as systemic analgesics (non-opioids and opioids), intra-articular analgesics, neuraxial blocks and peripheral nerve blockade. One such technique is adductor canal block (ACB) of the saphenous nerve. ACB involves injection of local anaesthetic into the adductor canal deep to the sartorius muscle.  The local anaesthetic then spreads throughout the adductor canal around the saphenous nerve resulting in sensory analgesia of its dermatomal distribution without any appreciable motor block.

Dexmedetomidine is a highly selective alpha 2 agonist acting through centrally mediated mechanism, having analgesic, anxiolytic, haemodynamic, sedative, and anaesthetic sparing effects. Due to its central sympatholytic effect, dexmedetomidine is useful in blunting haemodynamic responses in perioperative period. The peripheral actions of dexmedetomidine are mediated through post synaptic alpha 2a receptors. It causes local vasoconstriction, thus decreasing local anaesthetic spread and removal of local anaesthetic around the neural structures.

Dexmedetomidine as adjuvant to local anaesthetic in peripheral nerve blocks has shown to shorten the sensory block onset time and extend the duration of analgesia . In a recently published study by Keplinger et al, it was concluded that dexmedetomidine mixed with ropivacaine produces a dose dependent prolongation of sensory analgesia when used in ulnar nerve block. So far, there has been no randomized controlled trial to study the analgesic effect of dexmedetomidine as adjuvant to local anaesthetic ropivacaine in saphenous nerve block. The present study is planned to evaluate the efficacy of ultrasound guided ACB with local anaesthetic ropivacaine and dexmedetomidine as adjuvant in prolonging the duration of analgesia after ACB following arthroscopic ACL reconstruction surgery.


Sample size calculation-

Sample size was calculated on the basis of few pilot cases conducted in the department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh. It was observed that the mean opioid consumption in the patients receiving dexmedetomidine and ropivacaine with the ACB was 5mg with a standard deviation of 4.08 and intravenously was 5.25mg with a standard deviation of 3.4. In the control group patients receiving ropivacaine in the ACB catheter, the mean opioid consumption was 8.25mg with a standard deviation of 4.72. The sample size came out to be 29 patients per group at a power of 80% and confidence interval of 95%. To compensate for drop-outs, we decided to include 35 patients per group. So, the total sample size of our study will be 105 patients.

Results: The mean postoperative morphine consumption was significantly reduced till 4 hours in Group II 0.57 mg (0.98 [0-3]) (p = 0.011) and up to 6 hours in Group III 0.77 mg (1.00 [0-4]) (p = 0.004) compared to control group. The mean postoperative morphine consumption was comparable at 24 hours in Group III 3.57 mg (1.73 [0-8]) and Group II 3.34mg (1.92 [0-7]) (p = 1.000). The time to first analgesic request was significantly prolonged in group III 8.57 h (4.98) compared to group I 4.43 h (5.54) and group II 7.14 h (4.83) (p < 0.001). The VAS scores were comparable in all the three groups at all the time intervals studied (p > 0.05). The strength of the quadriceps muscle was well preserved, there were no significant differences in range of movement (p = 0.387) and timed-up-and-go tests (p = 0.469) between all the three groups at 24 hours postoperatively. There were no adverse effects i.e. hypotension or bradycardia observed during the study. The Ramsay Sedation Score (RSS) was significantly higher in group III 2.49 (0.74 [2-4]) as compared to group I 2.09 (0.28 [2-3]) and group II 2.09 (0.28 [2-3]) till 20 min postoperatively (p = 0.003).

Conclusion:  Postoperative morphine consumption was significantly reduced up to 4 h with perineural dexmedetomidine and up to 6 h with IV dexmedetomidine in patients undergoing arthroscopic ACL reconstruction surgeries.

 

 
Close