Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2015-07-31
2015-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section
NCT02716129
Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section
NCT03451695
To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine
NCT02440399
Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section
NCT01916915
Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Laparoscopic Hysterectomy
NCT03908060
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Post-operative analgesic requirements at two time points (12 hours and 24 hours) after surgery
2. Pain scores at two time points (12 hours and 24 hours) after surgery
3. Sedation scores at two time points (12 hours and 24 hours) after surgery
4. Post-operative nausea scores at two time points (12 hours and 24 hours) after surgery
5. Post-operative pruritis scores at two time points (12 hours and 24 hours) after surgery
2. To determine the impact that the patients' post-operative pain has on their activities in the first 24 hours after surgery
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Morphine100
1.8ml 0.5% hyperbaric bupivacaine with 0.1mg preservative-free morphine (mixed in 0.4ml normal saline to a volume of 2.3ml) administered into the intrathecal space
Morphine100
100mcg added to the spinal anaesthetic
Hyperbaric Bupivicaine
1.8ml 0.5% spinal bupivicaine with dextrose
Indomethacin
100mg Indomethacin suppository
Morphine50
1.8ml 0.5% hyperbaric bupivacaine with 0.05mg preservative-free morphine (mixed in 0.4ml normal saline to a volume of 2.3ml) administered into the intrathecal space
Morphine50
50mcg added to the spinal anaesthetic
Hyperbaric Bupivicaine
1.8ml 0.5% spinal bupivicaine with dextrose
Indomethacin
100mg Indomethacin suppository
Fentanyl25
1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space
Fentanyl
25mcg Fentanyl added to the spinal anaesthetic
Hyperbaric Bupivicaine
1.8ml 0.5% spinal bupivicaine with dextrose
Indomethacin
100mg Indomethacin suppository
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Morphine100
100mcg added to the spinal anaesthetic
Morphine50
50mcg added to the spinal anaesthetic
Fentanyl
25mcg Fentanyl added to the spinal anaesthetic
Hyperbaric Bupivicaine
1.8ml 0.5% spinal bupivicaine with dextrose
Indomethacin
100mg Indomethacin suppository
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
b) Patient refusal or inability to give informed consent c) Severe pre-eclampsia d) Eclampsia e) Patient unable to understand how to use the Patient Controlled Analgesia (PCA) pump, after appropriate counselling and training
* Intra-operative:
a) Obstetric Complications: i) Post-partum Haemorrhage ii) Ruptured Uterus iii) Still Birth b) Conversion to general anaesthesia intra-operatively c) Administration of supplementary intravenous opioid analgesics
* Post-operative:
1. Patients who have babies that require additional care, for a prolonged period, after birth eg. Neonatal ICU admission for ≥ 12hours or congenital abnormalities
2. Patients who require ICU or High care admission postoperatively for any intra-operative complications
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Witwatersrand, South Africa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sean Chetty
Senior Clinical Lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sean Chetty, FCA(SA)
Role: PRINCIPAL_INVESTIGATOR
University of Witwatersrand, South Africa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rahima Moosa Mother and Child Hospital
Johannesburg, Gauteng, South Africa
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M141181
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.