The analgesic effects of bupivacaine with fentanyl, dexamethasone or midazolam combinations for labour analgesia
| ISRCTN | ISRCTN14778465 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14778465 |
| Sponsor | C.K. Tedam University of Technology and Applied Sciences |
| Funder | Investigator initiated and funded |
- Submission date
- 17/03/2026
- Registration date
- 28/04/2026
- Last edited
- 02/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Many women experience strong pain during labour. Good pain relief can help women feel more comfortable and improve their overall experience of childbirth. This study looked at different drug combinations used in spinal anaesthesia to ease labour pain. The aim was to find out which combination of medicines works best, how quickly they start working, how long the pain relief lasts, how safe each option is for mothers and babies, and how satisfied women are with the pain relief they receive.
Who can participate?
Healthy pregnant women aged 18 to 45 years who were in active labour with the cervix open between 4 and 6 centimetres could take part. All participants needed to give consent and be medically assessed as suitable for spinal anaesthesia.
What does the study involve?
Women who agreed to take part were randomly placed into one of several groups. Each group received a different mixture of medicines injected into the lower back to relieve labour pain. These mixtures included low-dose bupivacaine on its own or combined with fentanyl, dexamethasone or midazolam. A placebo group received saline instead of an active drug combination. Neither the women nor the researchers knew which mixture was given, which helped make the study fair.
After the injection, the women’s vital signs were checked often. Their level of pain, the time it took for the pain relief to start, how long it lasted, any side effects and their satisfaction with the pain relief were recorded. Blood samples were taken before and after delivery to look for possible changes in blood parameters. Newborn health was assessed using the routine APGAR scoring system.
What are the possible benefits and risks of participating?
The study may have offered women effective pain relief during labour. Taking part also helped researchers learn more about which drug combinations are safest and most effective. Risks were the same as those normally linked with spinal anaesthesia. These may include low blood pressure, nausea, itching, a slow or fast heart rate or, rarely, nerve-related complications. The researchers monitored mothers and babies closely to ensure their safety.
Where is the study run from?
The study was carried out at Tamale Teaching Hospital in the northern region of Ghana.
When is the study starting and how long is it expected to run for?
The first participant was enrolled on 1 August 2024, and the final participant was enrolled on 20 October 2024. The study was completed on 1 October 2025.
Who is funding the study?
The study is funded by the research team and is investigator initiated. The sponsor is C. K. Tedam University of Technology and Applied Sciences (Ghana)
Who is the main contact?
Dr Sylvanus Kampo
sylvanuskampo@yahoo.com
Contact information
Principal investigator, Scientific, Public
Department of Anaesthesia and Intensive Care
C. K. Tedam University of Technology and Applied Sciences
Navrongo
-
Ghana
 ORCID ID |
0000-0002-3002-5124 |
|---|---|
| Phone | +233 559355229/ 208343773 |
| skampo@cktutas.edu.gh |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Dose comparison |
| Assignment | Single |
| Purpose | Supportive care, Treatment |
| Scientific title | The analgesic effects of bupivacaine with fentanyl, dexamethasone or midazolam combinations for labour analgesia: a comparative study |
| Study objectives | 1. To investigate the analgesic effects of intrathecal injection of low-dose bupivacaine with fentanyl, dexamethasone or midazolam combinations for labour pain management. 2. To investigate the side effects of low-dose bupivacaine with fentanyl, dexamethasone or midazolam combinations on mothers and the neonate. 3. To assess patients’ satisfaction with pain relief through the administration of low-dose bupivacaine with fentanyl, dexamethasone or midazolam combinations for labour analgesia. 4. To investigate the effects of intrathecal low-dose bupivacaine with fentanyl, dexamethasone or midazolam combinations on patients’ haematological parameters. |
| Ethics approval(s) |
Approved 19/03/2025, Tamale Teaching Hospital Ethical Review Commitee (P O Box TL 16, Tamale, +2332, Ghana; +233 372000180; research.development@tth.gov.gh), ref: TTHERC/20/03/25/05 |
| Health condition(s) or problem(s) studied | Labour analgesia |
| Intervention | Spinal anaesthesia/analgesia will be carried out on each participant using the drug mixtures assigned to the various groups to manage their labour pain. History will be taken from all the subjects at the pre-natal ward. These included their weight, age, gestational age, progress of the pregnancy, parity, maternal health history, bleeding disorders, pre-existing neurological deficits, anaesthesia-related obstetric history, airway assessment, back examination for any deformity, baseline vital sings including blood pressure, pulse rate and respiration will be taken and recorded. Laboratory investigations will be carried out to assess full blood count parameters. Intravenous access will be obtained with 16/18-gauge cannula and patients pre-loaded with 500mls of crystalloids (0.9% saline/ ringers lactate). The participants will be placed in a sitting or lateral position and their lumber region cleaned with savlon and methylated spirit to keep the area sterile. The needle insertion point will be located by the researchers using the landmarks such as the posterior superior iliac spine and the tuffier’s line. Lumber vertebrae three and four interspace (L3/L4) or lumber vertebrae four and five interspace (L4/L5) will be identified as the needle insertion points. Lidocaine 2% will be used to infiltrate the skin at the needle insertion point to minimise pain and discomfort to the patients. Lumber puncture will then be performed with a 25G/26G pencil point Whitacre spinal needle, which will be confirmed by observing free flow cerebrospinal fluid from the spinal needle. Patients will be randomised and assigned to the following groups: Group A: Bupivacaine + Fentanyl, Group B: Bupivacaine + Dexamethasone, Group C: Bupivacaine + Midazolam, Group D: Bupivacaine alone and Group E: Placebo. Computer randomization will be adopted and both investigators and participants will be blinded in order to minimise bias. Groups A, B and C will form the study groups whilst group D will be the control group. An intrathecal injection of low-dose 0.5% heavy bupivacaine hydrochloride by Aspen pharmacare, CAS RN 73360-54-0/ ATC Code N01BB01 (2.5mg) + fentanyl (25mcg) by Martindale pharmaceutical Ltd, PL OO156/0038 will be administered to participants in group A, those in group B will receive intrathecal injection of low-dose bupivacaine (2.5mg) + 2mg of dexamethasone with the brand name Dexataj, group C subjects will have intrathecal injection of low-dose bupivacaine (2.5mg) + midazolam (2mg) with batch number EP 15122303 by Verve company while group D (Control Group) participants will receive intrathecal injection of low-dose bupivacaine (2.5mg) + normal saline. After the spinal anaesthesia, participants will be advised to stay in bed for about twenty minutes and will then be assisted to ambulate when the block is settled. Vital signs of participants will be monitored every minute for the first five minutes then fifteen (15) minutes, thirty (30) minutes, forty (45) minutes and sixty (60) minutes interval for possible complications. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Bupivacaine, fentanyl, dexamethasone, midazolam |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 01/10/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 152 |
| Total final enrolment | 150 |
| Key inclusion criteria | 1. Consented labouring women 2. Classified as ASA I and ASA II (American Society of Anaesthesiologist) 3. Cervical dilatation of 4cm-6cm |
| Key exclusion criteria | 1. Contraindications to spinal anaesthesia 2. Allergic to any of the proposed drugs 3. ASA III classification and above 4. Cannot consent for themselves |
| Date of first enrolment | 01/08/2024 |
| Date of final enrolment | 20/10/2024 |
Locations
Countries of recruitment
- Ghana
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
02/04/2026: Trial's existence confirmed by Tamale Teaching Hospital Ethical Review Committee.
