| CTRI Number |
CTRI/2019/05/019255 [Registered on: 21/05/2019] Trial Registered Prospectively |
| Last Modified On: |
16/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare and evaluate the analgesic effect of dexmedetomidine 0.5mcg/kg as an adjuvant to 0.25% ropivacaine vs 0.25% ropivacaine alone in transverses abdominis plane block in infraumblical surgeries with regards to duration of analgesia and post operative analgesic consumption in 24 hours. |
|
Scientific Title of Study
|
ASSESSMENT OF THE POSTOPERATIVE ANALGESIC EFFICACY OF DEXMEDETOMIDINE AS AN ADJUVANT TO ROPIVACAINE IN TRANSVERSUS ABDOMINIS PLANE BLOCK FOR INFRAUMBILICAL SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHABESH PRASAD PANDA |
| Designation |
Junior Resident, PG 1st year |
| Affiliation |
GGS Medical College and Hospital |
| Address |
Dept Of Anaesthesia
GGS Medical College & Hospital
Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9938421063 |
| Fax |
|
| Email |
bhabesh99@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GURPREET SINGH |
| Designation |
PROFESSOR |
| Affiliation |
GGS Medical College and Hospital |
| Address |
Dept Of Anaesthesia
GGS Medical College & Hospital
Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
7009147551 |
| Fax |
|
| Email |
drgurpreetsinghggsmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHABESH PRASAD PANDA |
| Designation |
Junior Resident, PG 1st year |
| Affiliation |
GGS Medical College and Hospital |
| Address |
Dept Of Anaesthesia
GGS Medical College & Hospital
Faridkot
PUNJAB
151203
India |
| Phone |
9938421063 |
| Fax |
|
| Email |
bhabesh99@ymail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
GGS Medical College & Hospital
Faridkot
Punjab |
|
|
Primary Sponsor
|
| Name |
Dr Bhabesh Prasad Panda |
| Address |
PG Resident 1st yr
Dept Of Anaesthesia
GGS Medical College & Hospital
Faridkot |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kewal Krishan Gupta |
Associate Professor
Dept Of Anaesthesia
GGS Medical College & Hospital
Faridkot |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhabesh Prasad Panda |
GGS Medical College & Hospital |
Department Of Anaesthesia
Faridkot
PUNJAB |
9938421063
bhabesh99@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,GGS Medical College & Hospital,Faridkot |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Transversus Abdominis Plane Block for post operative analgesia in infra umbilical surgeries |
Ropivacaine 0.5% (20 ml) + NS (1ml)
Vs
Ropivacaine 0.5% (20ml) + Dexmedetomidine 0.5mcg/kg (1ml) |
| Intervention |
Transversus Abdominis Plane Block for post operative analgesia in infra umbilical surgeries |
The aim of our study is to compare the efficacy of ropivacaine with dexmedetomidine versus ropivacaine alone for transversus abdominis plane block for postoperative analgesia in patients undergoing infraumbilical surgeries in terms of duration of analgesia postoperatively, quality of analgesia and side effects (if any). The patients will be randomly allocated into 2 groups of 30 each, Group RS: will receive 20 ml of 0.5% ropivacaine and 1 ml of normal saline. Group RD: will receive 20 ml of 0.5% ropivacaine and 0.5 mcg/kg (1ml) of dexmedetomidine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) American Society of Anesthesiologists (ASA) grades I and II.
2) Male or female aged 18-65 years.
3) Patients undergoing infraumbilical surgeries like hernia repair, mesh hernioplasty, appendicectomy under spinal anesthesia.
|
|
| ExclusionCriteria |
| Details |
1) Patients with any contraindication to regional anesthesia like-
2) Patient’s refusal for TAP block.
3) Patients with local skin infection.
4) ASA-III & ASA-IV
5) Obese patients with BMI >30 kg/m2.
6) Patients with a history of anaphylaxis to local anesthetics and allergy to the study drugs.
7) Pregnant or lactating patients.
8) Patients with a history of pulmonary, cardiac, hematological, endocrinal or neuromuscular disorders.
9) Patients with a history of underlying psychological disorder.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesic effect between ropivacaine alone and ropivacaine with dexmedetomidine in ultrasound guided transverse abdominis plane block. |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare quality of analgesia and total postoperative analgesic consumption in 24 hours between ropivacaine alone and ropivacaine with dexmedetomidine in ultrasound guided transverse abdominis plane block. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/05/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
SUMMARY Assessment of the postoperative analgesic efficacy of Dexmedetomidine as an adjuvant to Ropivacaine in Transversus Abdominis Plane Block for infraumbilical surgeries Candidate: Bhabesh Prasad Panda AIMS AND OBJECTIVES: To compare and evaluate the analgesic effect of dexmedetomidine 0.5 mcg/kg as an adjuvant to 0.25% ropivacaine vs 0.25% ropivacaine alone in transverses abdominis plane block in infraumbilical surgeries with regards to duration of analgesia and postoperative analgesic consumption in 24 hours. MATERIALS AND METHODS: The present study will be conducted in a randomized manner in the department of Anesthesiology, GGS Medical College and Hospital, Faridkot. Inclusion criteria: 1.) American Society of Anesthesiologist (ASA) grade I and II. 2.) Patients aged between 18-65 years. 3.) Patients undergoing infraumbilical surgeries like hernia repair, mesh hernioplasty, appendicectomy under spinal anesthesia. Exclusion criteria: 1.) Patients with any contraindication to regional anesthesia or allergy to the study drugs. 2.) ASA-III &ASA-IV patients. 3.) Pregnant or lactating patients. 4.)Patient refusal. A total of 60 patients will be randomly allocated into 2 study groups i.e RS and RD of 30 patients each using computer generated randomization. Patient will be anesthetized with spinal anesthesia by giving 3ml of 0.5% heavy bupivacaine. Group RS will receive 20 ml drug volume of 0.25% ropivacaine + 1 ml of NS and Group RD will receive 20 ml drug volume of 0.25% ropivacaine + 0.5 mcg/kg dexmedetomidine in US guided TAP block. Duration of postoperative analgesia and total analgesic consumption in first 24 hours postoperatively will be noted and compared. After completion of the study, observations obtained will be tabulated and analyzed using appropriate statistical methods. P value <0.05 will be taken as significant and <0.001 will be taken as highly significant. This study will help to establish a better post operative pain management protocol in our institute in infra umbilical surgeries. |