| CTRI Number |
CTRI/2024/02/062748 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between dexmedetomidine and dexamethasone to levobupivacaine in erector spinae block for renal surgeries under general anaesthesia. |
|
Scientific Title of Study
|
COMPARISON OF DEXMEDETOMIDINE VS DEXAMETHASONE AS ADJUVANTS TO
LEVOBUPIVACAINE IN ULTRASOUND GUIDED ERECTOR SPINAE BLOCK FOR PATIENTS UNDERGOING RENAL
SURGERIES UNDER GENERAL ANAESTHESIA- A RANDOMISED CONTROLLED STUDY
|
| Trial Acronym |
A RANDOMISED CONTROLLED STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Bhumika Pathak |
| Designation |
Professor |
| Affiliation |
Pramukh swami medical college |
| Address |
Room No. 112,Department of anaesthesiology ,Shree krishna hospital, Pramukh swami medical college, karamsad ,anand . shree krishna hospital , Bhaikaka University, karamsad , Anand. Anand GUJARAT 388325 India |
| Phone |
9904438877 |
| Fax |
|
| Email |
docbhum29@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Bhumika Pathak |
| Designation |
Professor |
| Affiliation |
Pramukh swami medical college |
| Address |
Room No. 112,Department of anaesthesiology shree krishna hospital , Pramukh swami medical college ,karamsad ,anand. shree krishna hospital, Bhaikaka University, karamsad , anand. Anand GUJARAT 388325 India |
| Phone |
9904438877 |
| Fax |
|
| Email |
docbhum29@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Radhika Rajendrabhai Rajyaguru |
| Designation |
second year resident anaesthesiology |
| Affiliation |
Pramukh swami medical college and hospital |
| Address |
Room No 112 , Department of anaesthesiology, shree krishna hospital . Bhaikaka university ,karamsad ,anand Anand GUJARAT 388325 India |
| Phone |
9106615288 |
| Fax |
|
| Email |
radhikarajyaguru6@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHREE KRISHNA HOSPITAL ,PRAMUKH SWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY ,KARAMSAD,ANAND ,GUJARAT |
|
|
Primary Sponsor
|
| Name |
SHREE KRISHNA HOSPITAL |
| Address |
SHREE KRISHNA HOSPITAL,PRAMUKH SWAMI MEDICAL COLLEGE , GOKAL NAGAR,BHAIKAKA UNIVERSITY,KARAMSAD ,ANAND |
| Type of Sponsor |
Private 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 Bhumika Pathak |
Shree Krishna Hospital |
Pramukhswami Medical College, Bhaikaka university,karamsad ,Anand Anand GUJARAT |
9904438877
docbhum29@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N23||Unspecified renal colic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj Dexamethasone with inj Levobupivacaine |
Erector spinae block with Inj Levobupivacaine 30ml with Inj Dexamethasone 0.1mg/kg as adjuvant . |
| Intervention |
Inj Dexmedetomidine with inj Levobupivacaine |
Erector spinae block with inj Levobupivacaine 30ml with inj Dexmedetomidine 0.5mcg/kg as adjuvant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing Renalsurgeries under general anaesthesia.
2.Aged 18 to 60 years
3.American Society of Anesthesiologists Physical Status grade I-III |
|
| ExclusionCriteria |
| Details |
Patient refusal. patient with ASA IV and V |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative analgesia in dexmedetomidine and dexamethasone group. |
immediate post-op 0 hour, 1 hour (H1), 2 hours (H2), 4 hours (H4), 6 hours (H6), 12 hours (H12), 18 hours (H18) and
24hours(H24). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess and compare the time for 1st rescue analgesia
Assess and compare the occurrence of hemodynamic changes in both the groups
Total consumption of rescue analgesics |
immediate post-op (0hr), 1 hour (H1), 2 hours (H2), 4 hours (H4), 6 hours (H6), 12 hours (H12), 18 hours (H18) and
24hours(H24). |
|
|
Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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)
|
25/02/2024 |
| 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="6" 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
|
After obtaining ethics committee approval and written informed consent, patients undergoing renal surgeries (both laparoscopic renal surgeries and open renal surgeries) under general anesthesia will be recruited in this study. Participants will be randomly allotted in to two groups. A computersoftware WINPEPI will be used for the randomization. The random allocation will be kept in a sealed opaque envelops and they will be opened after written informed consent of eligible participants. Routine detailed Pre-anesthesia check- up will be carried out in all patients. On arrival to operation theatre, standard monitoring- electrocardiogram (ECG), pulse oximetry (SPO2) and non-invasive blood pressure (NIBP), End tidal Carbon Dioxide (ETCO2) monitoring will be attached and baseline vitals will be noted. Under all aseptic precautions ultrasound guided erector spinae block will be performed using linear probe (0.5-6 MHz) in sitting position at T10 level for renal surgeries. After visualizing transverse process at T10 level and erector spinae muscle, study drug will be injected in the fascial planes between transverse process of T10 vertebrae and erector spinae muscle. As per randomization, Patients in group-A will receive inj. levobupivacaine 0.25% 30ml (max dose 2mg/kg (IBW)) with injection dexamethasone (0.1mg/kg) as per ideal body weight (IBW) and in group-B patients will receive inj. levobupivacaine 0.25% 30ml (max dose 2mg/kg(IBW)) with injection dexmedetomidine 0.5mcg/kg in erector spinae block. Block will be performed either by anesthesia consultants or by 3rd year residents under supervision of anesthesia consultants. General anesthesia will be started by preoxygenating patient with 100% oxygen via closed circuit manual ventilation. Premedication’s will be given starting with Inj. glycopyrrolate (0.004mg/kg), inj. fentanyl (0.5- 2mcg/kg), in.j midazolam (0.1- 0.2mg/kg), inj. lignocaine (0.5-1mg/kg ) for blunting stress responses during intubation .Patient will be induced using Inj. propofol( 2mg/kg ) followed by check ventilation .Adequate muscle relaxation will be achieved with inj. succinylcholine 1mg/kg or inj. atracurium 0.5mg/kg or inj. vecuronium 1mg/kg . Patient will be intubated using conventional laryngoscope, long acting muscle relaxation will be achieved with inj. atracurium 0.5mg/kg or inj. vecuronium 1mg/kg. Patient is maintained on closed circuit controlled mechanical ventilation on oxygen +air +sevoflurane/Desflurane with bolus doses of muscle relaxant. Constant monitoring of hemodynamic parameters (Heart rate, blood pressure) and blood loss monitoring will be done . Postoperatively Post-operatively, the pain will be monitored using the visual analogue score (VAS) at rest and on deep breathing at times zero (H0), 1 hour (H1), 2 hours (H2), 4 hours (H4), 6 hours (H6), 12 hours (H12), 18 hours (H18) and 24hours(H24). If VAS ≥4 , rescue analgesia using Inj. tramadol 0.5mg/kg will be given. In case of persistent pain Inj. Tramadol 0.5mg/kg or inj. fentanyl 0.5mcg/kg will be given 6 hourly . Postoperatively patient’s overall recovery will be assessed using Quality of Recovery 40 questionnaire (QoR 40) .This questionnaire is available in public domain and it is been translated and back-translated into vernacular language by two different linguists. Any intraoperative or post operative side effects (like nausea, vomiting, giddiness ,Tingling numbness , hypotension, bradycardia) will be noted. Postoperatively side effects will be managed by the following: 1. Vomiting will be managed by giving inj ondansetron 0.1mg/kg 2. Hypotension is systolic blood pressure <20% of the baseline , Intravenous fluids like ringers lactate will be given, in case of persistent hypotension Inj mephentermine 0.1mg/kg will be administred. 3. Bradycardia is heart rate <20% of baseline ,Inj atropine 0.6mg will be given. 4. Tingling and numbness are transient effects and it will be observed for the same |