| CTRI Number |
CTRI/2021/04/033211 [Registered on: 28/04/2021] Trial Registered Prospectively |
| Last Modified On: |
27/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Dexamethasone and Magnesium Sulfate as an addition to Ropivacaine for Transverse Abdominis Plane Block in elective Cesarean section delivery under Spinal anesthesia for Post-Operative pain relief in central referral hospital, Gangtok |
|
Scientific Title of Study
|
Comparative evaluation of Dexamethasone and Magnesium Sulfate as an Adjuvant to Ropivacaine for Transverse Abdominis Plane Block in Elective Cesarean section delivery for Post-Operative Analgesia in central referral hospital, Gangtok: A Triple blind randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lhamo Dolma |
| Designation |
Assistant Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences. |
| Address |
Department of Anaesthesiology, level 6,Central referral hospital & Sikkim Manipal Institute of Medical Sciences,
5th mile, Tadong, Gangtok, Sikkim, 737102, India
East
SIKKIM
737102
India |
| Phone |
8860394768 |
| Fax |
|
| Email |
Lhadol30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lhamo Dolma |
| Designation |
Assistant Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences. |
| Address |
Department of Anaesthesiology, level 6,Central referral hospital & Sikkim Manipal Institute of Medical Sciences,
5th mile, Tadong, Gangtok, Sikkim, 737102, India
East
SIKKIM
737102
India |
| Phone |
8860394768 |
| Fax |
|
| Email |
Lhadol30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lhamo Dolma |
| Designation |
Assistant Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences. |
| Address |
Department of Anaesthesiology, level 6,Central referral hospital & Sikkim Manipal Institute of Medical Sciences,
5th mile, Tadong, Gangtok, Sikkim, 737102, India
East
SIKKIM
737102
India |
| Phone |
8860394768 |
| Fax |
|
| Email |
Lhadol30@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sikkim Manipal Institute Of Medical Sciences |
| Address |
central referral hospital, Sikkim Manipal Institue of Medical Sciences, 5th mile , Tadong , Gangtok, Sikkim 737102 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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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 |
| Dr Lhamo Dolma |
Central referral hospital, Sikkim Manipal Institute of Medical Sciences. |
Department of Anaesthesiology,
level 6, Central referral hospital , Sikkim Manipal Institue of Medical Sciences, 5th mile, Tadong, Gangtok
East
SIKKIM |
8860394768
lhadol30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS/IEC/2021-01 |
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: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral Transverse Abdominis Plane Block at the end of cesarean section |
under all aseptic precaution, ultrasound guided bilateral Transverse Abdominis Plane Block will be performed. Drugs will be administered in the block as per the random no. allocation of groups.
Group I: 20 ml 0.375% ropivacaine + 2ml normal saline
Group II: 20 ml 0.375% ropivacaine + 1ml of 4mg dexamethasone+ 1ml normal saline
Group III: 20 ml 0.375% ropivacaine + 1.5 ml of 150 mg Mgso4 + 0.5 ml normal saline
|
| Comparator Agent |
The analgesic efficacy will be compared amongst three drug group |
The analgesic efficacy will be compared amongst three drug group: Group I: 20 ml 0.375% ropivacaine + 2ml normal saline
Group II: 20 ml 0.375% ropivacaine + 1ml of 4mg dexamethasone+ 1ml normal saline
Group III: 20 ml 0.375% ropivacaine + 1.5 ml of 150 mg Mgso4 + 0.5 ml normal saline
Post operatively VAS SCORE, Hemodynamics (HR, BP), time to first analgesic request , side effects will be recorded for 24 hours. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. All parturient > 18 years undergoing lower segment caesarean section under spinal anesthesia
2. Parturient with ASA grade I and II
|
|
| ExclusionCriteria |
| Details |
1. refusal to give consent
2. history of drug allergy or local anesthetic toxicity
3. BMI >35kg/m2 and pregnancy weight <50kg (to limit maximum Ropivacaine dose to 3mg/kg)
4. Contraindications to regional anesthesia (bleeding diathesis, infection at the site of block and peripheral neuropathy)
5. pregnancy induced complications like pre-eclampsia, eclampsia, gestational diabetes
6. intra-operative complications like post-partum hemorrhage
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the duration of analgesia which is the time to the first request for additional analgesics (TFA) |
Time duration starting from time of TAP BLOCK till patient complains of pain or VAS4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. assess the post-operative pain quality by Visual analogue scale (VAS) score at rest and movement
2. opioid consumption over 24 h after surgery
3. patient satisfaction score
4. post-operative nausea score
5. side-effects if any
|
for period of 24 hours from the time of TAP block administered |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/05/2021 |
| 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
|
After completion , the results will be compiled and a research paper will be written which will be sent to national medical council approved indexed journal for consideration for possible publication |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [lhadol30@gmail.com].
- For how long will this data be available start date provided 01-05-2022 and end date provided 01-05-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
StudyTitle: Comparative evaluation of Dexamethasone and Magnesium Sulfate as an Adjuvant to Ropivacaine for Transverse Abdominis Plane Block in Elective Cesarean section delivery for Post-Operative Analgesia in central referral hospital, Gangtok: A Triple blind randomised controlled trial
Rationale: Pain is ranked highest among undesirable clinical outcome associated with Lower segment cesarean section. Transverse abdominis plane (TAP) block a relatively a new peripheral nerve block technique provides effective post operative analgesia in lower abdominal surgery such as lower segment cesarean section. Drug such as ropivacaine a local anesthetic is gaining popularity because of its less cardiotoxic and neurotoxic potential. However the analgesic duration of local anesthetic is limited. Hence to prolong the duration of analgesia various adjuvants are added. Dexamethasone and magnesium sulfate may be added to prolong the duration of analgesia. There is only one study comparing the analgesic efficacy of above two adjuvants when added to ropivacaine. No placebo comparison was done in the previous study . So this study will be done to compare the duration of analgesia provided by ropivacaine alone, ropivacaine with dexamethasone and ropivacaine with magnesium sulfate through ultrasound guided transverse abdominis plane block in patients undergoing elective lower segment cesarean section under spinal anesthesia. Aim: To evaluate the post-operative analgesic efficacy of two different adjuvants when added to local anesthetic in an ultrasound-guided transversus abdominis plane block in patients undergoing lower segment cesarean section under subarachnoid blockade.
Primary Objective: duration of analgesia which is the time to the first request for additional analgesics (TFA) Secondary Objectives: assess the post-operative pain quality by Visual analogue scale (VAS) score at rest and movement 2. opioid consumption over 24 h after surgery 3. patient satisfaction score 4. post-operative nausea score 5. side-effects, if any Setting: The study will be conducted in department of Anesthesiology, Central referral Hospital, Sikkim Manipal Institute Of Medical Sciences, Gangtok, Sikkim Design of study: Triple blind randomized controlled study. Duration of study: 1st May 2021-1st May 2022 Sample size: 30 patients in each group (a total of 90 patients). Participants: Parturients of 18-45 years of age belonging to ASA physical status I and II, undergoing elective lower segment cesarean section surgery under spinal anesthesia · Exclusion criteria: 1. refusal to give consent 2. history of drug allergy or local anesthetic toxicity 3. BMI >35kg/m2 and pregnancy weight <50kg (to limit maximum Ropivacaine dose to 3mg/kg) 4. Contraindications to regional anesthesia (bleeding diathesis, infection at the site of block and peripheral neuropathy) 5. pregnancy induced complications like pre-eclampsia, eclampsia, gestational diabetes 6. intra-operative complications like post-partum hemorrhage Methods: At the end of cesarean section, ultrasound guided transverse abdominis plane block will be done under all aseptic precautions along the mid axillary line. Drug will be given according to the group allotted as under: Group I: 20 ml 0.375% ropivacaine + 2ml normal saline Group II: 20 ml 0.375% ropivacaine + 1ml of 4mg dexamethasone+ 1ml normal saline Group III: 20 ml 0.375% ropivacaine + 1.5 ml of 150 mg Mgso4 + 0.5 ml normal saline
Post operatively VAS score will be assessed at rest and movement, hemodynamic variables will also be recorded, total tramadol consumption , nausea score and patient satisfaction score will be recorded up-to 24 hours from the time of TAP block administered. Primary outcome: duration of analgesia as defined by time from administration of drug through TAP Block till patients complains of pain with VAS≥ 4.
Secondary outcome measures: assess the post-operative pain quality by Visual analogue scale (VAS) score at rest and movement, opioid consumption over 24 h after surgery, patient satisfaction score, post-operative nausea score, side-effects, if any
Statistical Analysis: All the analysis will be carried out in latest SPSS, software version. The quantitative parameters like age, height, weight, time to first analgesic request and total doses of tramadol which are measured at one time point will be compared using unpaired t-test. Qualitative data like ASA PS, VAS score, nausea score and patient satisfaction score will be analyzed using the Chi-square test or Fischer’s exact test whichever is applicable. Repeated measures ANOVA will be used to compare the hemodynamic variables. A p-value<0.05 will be considered significant. |