| CTRI Number |
CTRI/2025/09/094910 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Local Anesthetic Drugs in Management of Labour Pain in Pregnant Women. |
|
Scientific Title of Study
|
Comparison of Continuous Infusion VS. Intermittent Bolus Administration of Epidural Levobupivacaine (0.125%) With Fentanyl For Labour Analgesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gurulingappa I Herakal |
| Designation |
Phd Scholar |
| Affiliation |
Srinivas University Institute of Allied Health Sciences |
| Address |
Srinivas University Institute of Department of Anesthesiology, Ground Floor, A Block, Room Number 102, Allied Health Sciences Mukka Shasihithlu.
Dakshina Kannada
KARNATAKA
575025
India |
| Phone |
8880985164 |
| Fax |
|
| Email |
nikhilherakal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanthkumar C |
| Designation |
Professor |
| Affiliation |
Srinivas University |
| Address |
Srinivas University Institute of Department of Anesthesiology, Ground Floor, A Block, Room Number 102, Allied Health Sciences Mukka Shasihithlu.
Dakshina Kannada
KARNATAKA
575025
India |
| Phone |
9738400843 |
| Fax |
|
| Email |
drprashanthkumarc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gurulingappa I Herakal |
| Designation |
Phd Scholar |
| Affiliation |
Srinivas University Institute of Allied Health Sciences |
| Address |
Srinivas University Institute of Department of Anesthesiology, Ground Floor, A Block, Room Number 102, Allied Health Sciences Mukka Shasihithlu.
KARNATAKA
575025
India |
| Phone |
8880985164 |
| Fax |
|
| Email |
nikhilherakal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Srinivas Institute of Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
Gurulingappa I Herakal |
| Address |
Srinivas Institute of Medical Sciences and Research Centre Mukka Shasihithlu Karnataka 575025 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prashanthkumar C |
Department of Anesthesiology and Critical Care Ground Floor Room number 1 |
Srinivas Institute of Medical Sciences and Research Centre Mukka Shasihithlu
Dakshina Kannada
KARNATAKA |
9738400843
drprashanthkumarc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SrinivasUniversityEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pregnancy |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Group 1 Continuous Infusion | Patients were positioned in either the sitting or lateral decubitus position for epidural placement. The insertion site (L3–L4 or L4–L5 interspace) was sterilized with an antiseptic solution, and lidocaine was administered for local infiltration. An epidural catheter was inserted at the L3–L4 or L4–L5 interspace, and correct placement was confirmed by aspiration and a test dose of 3 mL lidocaine with epinephrine.
A continuous infusion of levobupivacaine 0.125% with fentanyl 2 µg/mL was started at a rate of 8–12 mL/h, adjusted according to clinical response. | | 2 | Comparator Arm (Non Ayurveda) | | - | Group 2 Intermittent Bolus Administrition | Patients were positioned in either the sitting or lateral decubitus position for epidural placement. The insertion site (L3–L4 or L4–L5 interspace) was sterilized with an antiseptic solution, and lidocaine was administered for local infiltration. An epidural catheter was inserted at the L3–L4 or L4–L5 interspace, and correct placement was confirmed by aspiration and a test dose of 3 mL lidocaine with epinephrine.
An initial bolus of 10 mL levobupivacaine 0.125% with fentanyl 100 µg was given after confirming catheter placement. Maintenance of epidural analgesia was achieved by administering bolus doses of 5–10 mL levobupivacaine 0.125% with fentanyl 50–100 µg depending on the participant’s pain level (VAS score) and cervical dilation. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women aged 18 to 45 years.
2. Pregnant women at term, defined as 37 to 42 weeks of gestation.
3. Singleton pregnancy.
4. Pregnant women in active labor, defined as regular contractions with cervical dilation of at least 3 cm.
5. Labor Analgesia Requirement:
6. Pregnant women seeking epidural analgesia for labor pain relief.
7. Participants willing and able to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women outside the term pregnancy range (less than 37 or more than 42 weeks of gestation).
2. Multiple gestation (e.g., twins, triplets).
3. Pregnant women with contraindications to epidural analgesia, such as bleeding disorders or infection at the insertion site.
4. Known allergies to Levobupivacaine, fentanyl, or any of the components used in the epidural analgesia solution.
5. Pregnant women with pre-existing medical conditions that may complicate labor or epidural administration, such as severe heart disease or uncontrolled hypertension.
5. Pregnant women unable to communicate effectively or provide feedback regarding their pain level during labor (e.g., due to cognitive impairment).
6. Women with unstable labor, including non-reassuring fetal status or other obstetric emergencies.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The expected outcomes of this study comparing continuous infusion versus intermittent bolus administration of epidural Levobupivacaine with fentanyl for labor analgesia are multifaceted and can contribute significantly to the field of obstetrics and anaesthesiology. |
Baseline Between 3 week and 6 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the potential benefits of continuous infusion & intermittent bolus administration of epidural Levobupivacaine 0.125% with fentanyl for labour analgesia |
Baseline of 9 week & 10 week. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/09/2025 |
| 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="2"
Months="0"
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
|
The research can identify areas that require further investigation, potentially paving the way for future studies on optimizing labor analgesia techniques. Ultimately, the expected outcomes of this PhD research study can provide valuable insights into the choice of epidural analgesia administration methods during labor, helping healthcare providers make informed decisions and potentially improving the overall experience and safety of laboring women. |