| CTRI Number |
CTRI/2026/01/101370 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of adding Dexmedetomidine to spinal block in patients for elective cesarean section on incidence of postdural puncture headache :A randomized control study. |
|
Scientific Title of Study
|
Effect of intrathecal Dexmedetomidine on incidence of postdural puncture headache (PDPH) in parturients undergoing elective LSCS:A randomized control double blind study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Gupta |
| Designation |
Professor |
| Affiliation |
Graphic Era institute of medical sciences |
| Address |
Department of Anaesthesiology, Graphic Era institute of Medical sciences
Dehradun
32 milestone chakrata road dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7060665955 |
| Fax |
|
| Email |
priyankamalhotra82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Gupta |
| Designation |
Professor |
| Affiliation |
Graphic Era institute of medical sciences |
| Address |
Department of Anaesthesiology
Graphic Era institute of Medical Sciences
Dehradun
32 milestone chakrata road dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7060665955 |
| Fax |
|
| Email |
priyankamalhotra82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Gupta |
| Designation |
Professor |
| Affiliation |
Graphic Era institute of medical sciences |
| Address |
Department of Anaesthesiology
Graphic Era institute of Medical Sciences
Dehradun
32 milestone chakrata road dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7060665955 |
| Fax |
|
| Email |
priyankamalhotra82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Graphic Era institute of Medical Sciences
Dehradun
Uttarakhand
248001 India |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 |
| Priyanka Gupta |
Graphic Era institute of medical sciences |
Department of Anaesthesiology ,Maternity Operation theatre complex,2nd floor
Graphic Era Hospital
Dehradun
UTTARANCHAL |
07060665955
priyankamalhotra82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GEU-GEIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Parturients will be divided into two groups randomly using a computer-generated random number list, with Group C (control) will receive 2.2 ml of 0.5% hyperbaric bupivacaine AND 0.2ml NS in SAB. Group D (demedetomidine) will receive 2.2 ml of 0.5% hyperbaric bupivacaine and preservative free dexmedetomidine 5ug in SAB. SAB will be given in sitting position under all aseptic precautions with 26G quincke spinal needle,bevel oriented parallel to dural fibres, at L3-L4 or L2-L3 intervertebral space after locally anaesthetizing the field of needle insertion with 2ml of 2% lidocaine. Incision will be given once T6 sensory level is achieved.Patients will be observed for PDPH for 72 hours. Those who complaint of headache will be asked details to diagnose PDPH by trained staff not a part of the study. Time of onset of headache will be noted. Severity will be evaluated using the verbal rating scale (VRS) rated from 0-10, where 0 = no pain and 10 = worst imaginable pain. Once the diagnosis of PDPH is confirmed clinically, patients will be advised bed rest, plenty of fluids, caffeine. Symptomatic patients (VRS3) will be given IV paracetamol 10-15mg/kg with IV g and observed for 45 minutes. If headache is not relieved,IV paracetamol will be repeated. Intractable PDPH will be managed by epidural blood patch. |
| Intervention |
Dexmedetomidine is added intrathecally to know its effect in prevention of PDPH in parturients |
Parturients will be divided into two groups randomly using a computer-generated random number list, with Group C (control) will receive 2.2 ml of 0.5% hyperbaric bupivacaine AND 0.2ml NS in SAB. Group D (demedetomidine) will receive 2.2 ml of 0.5% hyperbaric bupivacaine and preservative free dexmedetomidine 5ug in SAB. SAB will be given in sitting position under all aseptic precautions with 26G quincke spinal needle,bevel oriented parallel to dural fibres, at L3-L4 or L2-L3 intervertebral space after locally anaesthetizing the field of needle insertion with 2ml of 2% lidocaine. Incision will be given once T6 sensory level is achieved.Patients will be observed for PDPH for 72 hours. Those who complaint of headache will be asked details to diagnose PDPH by trained staff not a part of the study. Time of onset of headache will be noted. Severity will be evaluated using the verbal rating scale (VRS) rated from 0-10, where 0 = no pain and 10 = worst imaginable pain. Once the diagnosis of PDPH is confirmed clinically, patients will be advised bed rest, plenty of fluids, caffeine. Symptomatic patients (VRS3) will be given IV paracetamol 10-15mg/kg with IV g and observed for 45 minutes. If headache is not relieved,IV paracetamol will be repeated. Intractable PDPH will be managed by epidural blood patch. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA-II,20-40 years of age, posted for elective LSCS, weighing less than 80kgs |
|
| ExclusionCriteria |
| Details |
those with recurrent headache (migraine), neurological dysfunction, hypertension, diabetes, thyroid disease, spinal deformity, refusal to participate and contraindications to SAB |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Incidence of PDPH in parturients for elective LSCS given intrathecal dexmedetomidine. |
continous monitoring of parturient will be done for 72 hours after spinal block.
Any time during this duration,if parturient complains of PDPH, it will be taken as positive response |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Requirement of epidural blood patch in patients presented with PDPH
2. Incidence of post spinal hypotension & correlation to incidence of PDPH
|
Heart rate,Mean arterial pressure & saturation will be noted as baseline, every 2 minutes for 10 minutes & every 5 minutes till 45 minutes of giving spinal block |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="0"
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
|
•This prospective randomized control clinical trial will be conducted at Graphic Era institute of medical sciences, Dehradun, Uttarakhand after approval from institutional ethics committee and registering with Clinical Trial Registry of India (CTRI). A total of 130 parturients, ASA-II,20-40 years of age, posted for elective LSCS, weighing less than 80kgs will be enrolled in the study. Written informed consent will be taken from all the patients. Exclusion criteria will include those with recurrent headache (migraine), neurological dysfunction, hypertension, diabetes, thyroid disease, spinal deformity, refusal to participate and contraindications to SAB.All patients will undergo detailed preanaesthetic check. Eighteen-gauge cannula will be secured in nondominant hand preoperatively. Fasting duration will also be noted in all the parturients. During this time, Ringer lactate (RL) will be infused @ 4ml/kg/hr. In operation theatre, standard ASA monitors (noninvasive blood pressure, pulse oximeter and electrocardiogram) will be attached. •Parturients will be divided into two groups randomly using a computer-generated random number list, with Group C (control) receiving 2.2 ml of 0.5% hyperbaric bupivacaine AND 0.2ml NS in SAB. Group D (dexmedetomidine)will receive 2.2 ml of 0.5% hyperbaric bupivacaine and preservative free dexmedetomidine 5ug in SAB. SAB will be given in sitting position under all aseptic precautions with 26G quincke spinal needle, bevel oriented parallel to dural fibers, at L3-L4 or L2-L3 intervertebral space after locally anaesthetizing the field of needle insertion with 2ml of 2% lidocaine. Incision will be given once T6 sensory level is achieved. All spinal blocks will be given in single prick. Those requiring multiple pricks will be excluded from the analysis. Parturients will be positioned 15 degree left lateral to avoid aortocaval compression. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR) and arterial oxygen saturation(SpO2) will be noted every 2mins till 10 mins and every 5min thereafter post spinal injection. Intraoperative hypotension will be labelled as SPB <100mmHg or MAP<60 mmHg and will be managed by boluses of IV ephedrine 5mg.Bradycardia will be considered at HR of <50bpm and treated with IV atropine 0.6mg stat. After delivery of baby, IV oxytocin 20U will be given as slow infusion for uterine contraction. Apgar score will be assessed by a pediatrician at 1 and 5 min of delivery of baby. •Parturients will be divided into two groups randomly using a computer-generated random number list, with Group C (control) receiving 2.2 ml of 0.5% hyperbaric bupivacaine AND 0.2ml NS in SAB. Group D (dexmedetomidine)will receive 2.2 ml of 0.5% hyperbaric bupivacaine and preservative free dexmedetomidine 5ug in SAB. SAB will be given in sitting position under all aseptic precautions with 26G quincke spinal needle, bevel oriented parallel to dural fibers, at L3-L4 or L2-L3 intervertebral space after locally anaesthetizing the field of needle insertion with 2ml of 2% lidocaine. Incision will be given once T6 sensory level is achieved. All spinal blocks will be given in single prick. Those requiring multiple pricks will be excluded from the analysis. Parturients will be positioned 15 degree left lateral to avoid aortocaval compression. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR) and arterial oxygen saturation(SpO2) will be noted every 2mins till 10 mins and every 5min thereafter post spinal injection. Intraoperative hypotension will be labelled as SPB <100mmHg or MAP<60 mmHg and will be managed by boluses of IV ephedrine 5mg.Bradycardia will be considered at HR of <50bpm and treated with IV atropine 0.6mg stat. After delivery of baby, IV oxytocin 20U will be given as slow infusion for uterine contraction. Apgar score will be assessed by a pediatrician at 1 and 5 min of delivery of baby. |