A Randomized Control Trial on Intravenous Paracetamol Versus Intramuscular Tramadol as Intra Partum Labor Analgesia in Pregnant Women at Alex Ekwueme Federal University Teaching Hospital Abakaliki

METHODOLOGY STUDY DESIGN This will be open label randomized controlled study on the comparison of intravenous paracetamol versus intramuscular tramadol as labour analgesia at the Alex Ekwueme Federal University Teaching Hospital, Abakaliki and St Patrick's Mile 4 Hospital, Abakaliki where both the researcher and trial participants are fully aware of which treatment group the participants are in and what treatments are assigned to them. 3.2. STUDY BACKGROUND The study will be done at the Alex Ekwueme Federal University Teaching Hospital, Abakaliki (AE-FUTHA), Ebonyi state. Ebonyi state is one of the 5 south eastern states in Nigeria. It was created in 1996 and is inhabited predominantly by the Igbo tribe. Abakaliki is the state capital. The state has a population of about 3 million people and occupies a land mass of 5932 kilometers square. Majority of the inhabitants engage in subsistent farming, petty trading and civil service as their occupation. Literacy level generally is low while poverty is prevalent among this population. Alex Ekwueme Federal University Teaching Hospital, Abakaliki (AE-FUTHA) was established in December 2011 following the merger between the defunct Federal medical Centre, Abakaliki and then Ebonyi State University Teaching Hospital, Abakaliki. It receives referrals from all parts of the state and neighboring states of Abia, Benue, Cross-River and Enugu. There are 54 obstetric bed spaces including postnatal and antenatal wards. The hospital runs a busy obstetric unit which is composed of five teams that are subdivided into two units, each unit manned by at least three consultants, senior registrars, registrars and house officers. The department of Obstetrics and Gynecology runs antenatal clinics managed by consultants and resident doctors assisted by trained nurses, midwives and other health workers. The antenatal clinic holds from Monday through Friday with about 5000 antenatal registrations per year. Antenatal clients are booked and assigned to consultants according to the units/teams running antenatal clinic that day. Preliminary data showed that the hospital had 984 deliveries in 2021 with approximately 82 deliveries per month. St. Patrick's Mile 4 Hospital, Abakaliki was established in 1948. It is a missionary hospital managed by Reverend Sisters. It is one of the hospitals in which residents from the AE-FUTHA pass through for their labour ward posting and/or rural posting in obstetrics and gynecology. The obstetrics and gynecology department of the hospital is run by two obstetrician- gynecologists with senior registrars and registrars posted from AE-FUTHA as well as medical officers and the nursing staff. The hospital runs antenatal clinic on Mondays to Wednesdays. It had 2100 deliveries in 2021 with approximately 175 per month.

STUDY SITE The study will be conducted in the labour ward suites of AE-FUTHA and St. Patrick Mile 4 Hospital Abakaliki.

STUDY POPULATION Participants in this study will be drawn from the population of booked women admitted in active phase of labour at the Alex Ekwueme Federal University Teaching Hospital, Abakaliki and St Patrick Mile 4 Hospital, Abakaliki who meet the inclusion criteria. The patients will be selected once they come in active labour (cervical dilatation of greater or equal to 4cm). Parturients will be counseled at the antenatal clinic to present once they start having symptoms of labour. They are usually educated about labour analgesia during the antenatal clinic period and they will be further educated about this particular work by the chief researcher and research assistants. Once the parturient presents in labour and a diagnosis of active labour made, those who meet the inclusion criteria and consented will be recruited into the study. The details of the study they were educated about at the antenatal clinic will be further briefly explained to them before informed consent will be obtained. They will also be assured of confidentiality. A detailed history will be obtained and a thorough examination will be carried out on all the patients in labour. They will be assured of optimal care even if they did not consent to participate in the study

STUDY DURATION The study will last for a period of 3 months. This was extrapolated from the finding that AEFUTHA and St Patrick's Mile 4 Hospital had a total of 3084 labour deliveries in 2021. Approximately 257 labour deliveries per month for both hospitals.

INCLUSION CRITERIA