| CTRI Number |
CTRI/2017/02/007963 [Registered on: 27/02/2017] Trial Registered Prospectively |
| Last Modified On: |
05/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral paracetamol as an adjunct to labour epidural analgesia |
|
Scientific Title of Study
|
Efficacy of oral paracetamol for sparing the dosage of levobupivacaine-fentanyl combination in patient-controlled combined spinal-epidural analgesia in labouring parturients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reecha |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government College and Hospital Chandigarh |
| Address |
Department of Anaesthesia and Intensive care Government Medical College and Hospital Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8146784969 |
| Fax |
|
| Email |
reechapanghal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukanya Mitra |
| Designation |
Professor |
| Affiliation |
Government College and Hospital Chandigarh |
| Address |
Department of Anaesthesia and Intensive care Government Medical College and Hospital Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121521 |
| Fax |
|
| Email |
drsmitra12@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reecha |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government College and Hospital Chandigarh |
| Address |
Department of Anaesthesia and Intensive care Government Medical College and Hospital Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8146784969 |
| Fax |
|
| Email |
reechapanghal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care Government Medical Colege and Hospital Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Government Medical College and Hospital
Sector 32 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 Reecha |
Government Medical College and Hospital Chandigarh |
Clean labour room level - 1 A block
Government medical college and hospital sector 32
Chandigarh
Chandigarh
CHANDIGARH |
8146784969
reechapanghal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA Grade 1 and 2 parturients more than 18 years of age who give consent for labour analgesia |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1-combined spinal epidural with oral paracetamol group |
Parturients will receive 1 gram oral paracetamol 45 mins before combined spinal- epidural block |
| Comparator Agent |
Group 2- combined spinal epidural with placebo group |
Parturients will receive a placebo of same size and shape 45 minutes before combined spinal-epidural block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1)ASA Grade 1 and 2
2)Age more than 18 years
3)Primigravida Single gestation
4)Cephalic presentation at 36 completed weeks of gestation
5)In early spontaneous labour(cervical dilatation < 5cm)
6)Baseline pain score > 30(on a 0-100 VAS)
7)Able to use PCEA pump
8)Requesting epidural analgesia for labour |
|
| ExclusionCriteria |
| Details |
1)Refusal by parturient
2)Parturients who had received parenteral opiods in the last 4 hours
3)Systemic and local sepsis
4)Deranged coagulation profile
5)Parturients having multiple pregnancies and premature labour
6)Obstetrics complications(eg. PROM)
Chorioamnionitis
7)Patients with hepatic and renal impairment
8)Unable to swallow oral tablets
9)HELLP syndrome
10)Noncephalic presentations
11)Allgery to study drugs i.e levobupivacaine,fentanyl,paracetamol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hourly total consumption of levobupivacaine + fentanyl mixture, including both continous background infusion plus bolus doses(in ml) starting from 1 hour after ingestion of paracetamol or placebo, for duration of labour |
Till delivery of baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal satisfaction(VAS)
Pain score(VAS)
Sensory and motor block characteristics
Hemodynamic parameters of mother
Foetal heart rate
Duration of second stage of labour
Mode of delivery
Apgar scores
Adverse effects |
Till delivery of baby |
|
|
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)
|
01/09/2017 |
| Date of Study Completion (India) |
15/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Labour pain is the frequently described as the most severe pain that a woman will experience during her lifetime. Neuraxial analgesia is the only technique that can completely relieve the pain of labour and is gold standard for labour analgesia. One of the most popular and effficient method of pain relief is the epidural analgesia tenchnique done by placing a catheter in epidural space. A better option from among the preferred epidural anaesthesia is the use of patient controlled epidural analgesia(PCEA) for labour and delivery. Combined spinal-epidural(CSE) analgesia has become widely popular alternative to low dose epidural analgesia for labour. Low concentrations of bupivacaine provide excellent analgesia without significant motor block. Levobupivacaine has been increasingly used because of its safer pharmacological profile. Use of fentanyl in labour analgesia is not associated with side effects like drowsiness, nausea, respiratory depression in neonates reported in use of other systemic opiods as pethidine, tramadol, remifentanyl. Injection paracetamol has been used as an adjunct to analegsia in number of studies in different surgical settings. However there is only one study of intravenous paracetamol used as an adjunct to intrapartum analgesia drug. It has been seen that overall bioavailability of oral paracetamol is equivalent to intravenous paracetamol. Therefore the aim of the present study is the evaluate the efficacy of oral paracetamol as an adjunct and dose sparing effect on total consumption of levobupivacaine and fentanyl combination in labouring parturients using PCEA.
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