Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306521096535 Date of Approval: 27/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effects of labour analgesia on outcomes of labour, a randomized control study between epidural bupivacaine and intravenous tramadol.
Official scientific title A randomized controlled trial between epidural bupivacaine and intravenous bupivacaine for labour analgesia.
Brief summary describing the background and objectives of the trial BACKGROUND Labour pain is one of the severe pains experienced by women. If severe and unrelieved, it may be deleterious to the mother and the fetus. Despite perceived social and cultural aversion to pain relief in labour, the majority of women want pain relief in labour. Epidural analgesia and opioid are the commonest labour analgesia. OBJECTIVES To compare the outcomes of labour in women who had epidural bupivacaine with those who were administered intravenous tramadol for pain relief in labour.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 11/11/2018
Actual trial start date 11/11/2018
Anticipated date of last follow up 05/07/2019
Actual Last follow-up date 30/06/2020
Anticipated target sample size (number of participants) 114
Actual target sample size (number of participants) 107
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NHREC/25/10/2013
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Epidural group Throughout the duration of labour Epidural group: After establishment of epidural catheter by senior anaesthetist, a test dose of 3ml of 2% Lidocaine with adrenaline was injected while maintaining verbal communication with the parturient. The absence of maternal tachycardia in the absence of uterine contraction and sudden lower limb weakness after 5 minutes ruled out accidental intravenous or intrathecal placement respectively. The catheter was then secured with plaster to the back of the woman. A 0.25% bupivacaine was then administered in 2-3 small boluses of 5ml to achieve a cephalad sensory level of approximately T10; at the level of the umbilicus. After about 15-20minutes, a loss of sensation was then assessed by pinprick or cold water. The motor block was assessed by asking the parturient to flex the hips and doses of local anaesthetics agents were reduced in the presence of significant motor block. Four parturients had inadvertent needle placement into the subarachnoid space and were excluded from the study and intravenous tramadol was administered. Maintenance of the analgesia was achieved by a top-up dose of 5-10ml of 0.25% of bupivacaine. 57
Control Group Tramadol group Throughout labour Control/Tramadol group: A start dose of 100mg of intravenous tramadol was given slowly for 1-2 minutes and this was maintained with the same dose in 500ml of 5% dextrose water. This was infused at a rate of 13-20 drops/min delivering 8-12mg/hr throughout labour using fluid giving set. The parturients were monitored for adverse effects such as drowsiness and respiratory depression. Drowsiness was graded using 4-point scales (0- no sedation, 1-subjective sedation, 2- sleeping after contractions but awake during contractions, 3- sleeping during contraction). None of the women have drowsiness score >1, respiratory rate < 8cycles/min or oxygen saturation <94% that might have warranted discontinuation of the tramadol and treatment with intravenous naloxone. 57 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria were: 1). Consenting nulliparous women age between 18 and 35years. 2). Women with a singleton fetus in cephalic presentation. 3). Women in established spontaneous labour at term and cervical dilatation of 4-6cm. 4). Women whose anaesthetic risk assessment is ASA physical status class II The exclusion criteria were: 1). Women who do not consent 2). Women with weights greater than 90kg 3). Women with heights less than 1.5m. 4). Women with complicated pregnancies that require emergency management 5). Women with contraindications to epidural analgesia or opioid administration. Adult: 19 Year-44 Year 18 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/06/2018 Research and Ethics Committee Federal Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Askaka Road, Gombe Gombe 234566 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of labour, mode of delivery After delivery and up to 7days of life for the neonate
Secondary Outcome APGAR Score of the neonate, neonatal admission at neonatal intensive care unit and analgesic efficacy of epidural bupivacaine and intravenous tramadol Throughout labour and up to 7days of life for the neonate
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Teaching Hospital Gombe Ashaka Road, Gombe Gombe 23456 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded by principal investigator ajuji waziri gombe 23456 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Olakunle Azeez Ajuji Waziri Gombe 23456 Nigeria Individual
Secondary Sponsor Federal Teaching Hospital Ashaka Road Gombe 23456 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olakunle Azeez zizobaba9@gmail.com +2348169209586 Ajuji Waziri Street,
City Postal code Country Position/Affiliation
Gombe 23456 Nigeria Consultant Obstetricicain and Gynaecologist Federal Teaching Hospital Gombe
Role Name Email Phone Street address
Public Enquiries Panda Usman usmanpanda222@gmail.com +2348035944303 federal low cost
City Postal code Country Position/Affiliation
Gombe 23456 Nigeria Consultant Anaesthetist Federal Teaching Hospital Gombe
Role Name Email Phone Street address
Scientific Enquiries Yahaya Usman uryahaya@yahoo.com +2348035880853 federal low cost
City Postal code Country Position/Affiliation
Gombe 23456 Nigeria Consultant Obstetricicain and Gynaecologist Federal Teaching Hospital Gombe
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual data collected related to primary and secondary outcomes during the trial after deindentification. Clinical Study Report,Statistical Analysis Plan,Study Protocol After publication. No end date Anyone who wishes to access the data for research purposes
URL Results Available Results Summary Result Posting Date First Journal Publication Date
The link will be included after publication No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information