| CTRI Number |
CTRI/2019/04/018708 [Registered on: 24/04/2019] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE STUDY OF PREOPERATIVE USE OF ORAL ANALGESIC WITH AND WITHOUT INTRAVENOUS STEROID FOR POSTOPERATIVE PAIN, NAUSEA AND VOMITING IN PATIENTS OF CESAREAN SECTION UNDER SPINAL ANAESTHESIA. |
|
Scientific Title of Study
|
PROSPECTIVE COMPARATIVE STUDY OF PREOPERATIVE USE OF ORAL GABAPENTIN WITH AND WITHOUT INTRAVENOUS DEXAMETHASONE FOR POSTOPERATIVE PAIN, NAUSEA AND VOMITING IN PATIENTS UNDERGOING CESAREAN SECTION UNDER SPINAL ANESTHESIOLOGY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sachitha D |
| Designation |
Postgraduate student |
| Affiliation |
bangalore medical college and research institute |
| Address |
#110, 6th street, bank avenue, babusabpalya, banaswadi
Bangalore
KARNATAKA
560043
India |
| Phone |
9535052754 |
| Fax |
|
| Email |
sach_d_red@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya Rohit |
| Designation |
Assistant professor |
| Affiliation |
bangalore medical college and research institute |
| Address |
BMCRI, Fort, K.R Road,
Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9611106641 |
| Fax |
|
| Email |
dr.soumyarohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sachitha D |
| Designation |
Postgraduate student |
| Affiliation |
bangalore medical college and research institute |
| Address |
#110, 6th street, bank avenue, babusabpalya, banaswadi
KARNATAKA
560043
India |
| Phone |
9535052754 |
| Fax |
|
| Email |
sach_d_red@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute,fort, K.R. road, bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
Sachitha D |
| Address |
#110, 6th street, bank avenue, babusabpalya, banaswadi, bangalore 560043 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sachitha D |
Bangalore medical college and research institute |
OT Complex, department of OBG, 3rd floor, Vani vilas hospital, BMCRI, Fort, K.R road, bangalore 560043
Bangalore
KARNATAKA |
9535052754
sach_d_red@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
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: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexamethasone |
The analgesic effects of steroids is through peripheral inhibition of phospholipase enzymes which decreases the products of the cyclooxygenase and lipoxygenase pathways in the inflammatory response. Dexamethasone modulates neurotransmitter or glucocorticoid receptor density in the nucleus of the solitary tract, the raphe nucleus and the area postrema thereby exerting its antiemetic effect. Dexamethasone crosses the placenta to the fetus and is excreted in the breast milk, without any adverse outcomes. |
| Intervention |
gabapentin |
Gabapentin, is a structural analogue of neurotransmitter GABA (gamma amino butyric acid) and acts on the same receptors. It binds to α2δ subunit of the spinal voltage gated calcium channel and decreases the calcium influx, which decreases the release of glutamate and substance P (excitatory neurotransmitters) from primary nociceptive afferents, thereby modulating nociceptive transmission. Antiemetic effect is by mitigation of tachykinin neurotransmitter activity. Although the trans placental transfer of gabapentin does occur, no increased risks for adverse fetal or neonatal outcomes have been attributed to its use. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Women with singleton, uncomplicated pregnancy at term (>37 completed weeks).
2) Women belonging to American society of anaesthesia category I-II and willing to give informed written consent.
3) Women scheduled to undergo elective cesarean delivery under spinal anesthesia
|
|
| ExclusionCriteria |
| Details |
1) pregnancy with obstetric complications like hypertention, diabetes, oligohydramnios, polyhydramnios, antepartum haemorrhage, etc
Patients with contraindication to neuraxial anesthesia.
2) Patients known to be epileptics or on antiepileptic medications.
3) Patients with deranged renal function tests or liver function tests.
4) Patients with psychiatric disorder or unable to give consent.
5) Patients scheduled to undergo emergency cesarean delivery.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Pain assessment using Numerical Rating Scale (NRS).
2) PONV assessment using PONV Impact Scale Score.
|
postoperative period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Neonatal outcome using APGAR Score.
2) Maternal Sedation using Ramsay Sedation Score.
|
postoperative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2019 |
| Date of Study Completion (India) |
31/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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)?
|
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Brief Summary
|
Postoperative pain is the most common and unpleasant complication in women undergoing cesarean section. Systemic and neuraxial medications, non steroidal anti inflammatory drugs, often in combination are used to treat pain in this population, however they do not relieve pain completely. This study will add on to the existing techniques to alleviate postoperative pain, nausea and vomiting in patients undergoing cesarean section |