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This is an interventional drug trail to evaluate the effect of different intrathecal opioids on post-operative pain experiences in women who have undergone caesarean section surgery.
To evaluate the effect of three different intrathecal opioid mixtures on post-operative pain experiences in women who have undergone caesarean section surgery, relating specifically to:
To determine the impact that the patients' post-operative pain has on their activities in the first 24 hours after surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine100 | Active Comparator | 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 |
|
| Morphine50 | Active Comparator | 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 |
|
| Fentanyl25 | Active Comparator | 1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine100 | Drug | 100mcg added to the spinal anaesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Analgesic Requirements measured by total morphine usage on Patient Controlled Analgesic pump | The total administered morphine dose administered to the patient through the PCA pump will be documented. This is documented at 24 hours after surgery. | For 24 hours after surgery |
| Patient Pain Score measured by the Numeric Pain Rating scale | The instrument consists of 11 numbered points ( 0 to 10) each of which represent a different pain level for the patient. The scale ranges from 0=NO PAIN up to 10= worst pain possible. This is assessed at 24 hours after surgery. | 24 hours after surgery |
| Patient sedation scores measured by a 4 point sedation scale | The instrument consists of 4 numbered points ( 0 to 3) each of which represent a different level of sedation for the patient. The scale ranges as follows: 0 =awake, 1 = mild drowsiness, 2 = moderate drowsiness, easily awaken, 3 =difficult to arouse.This is assessed at 24 hours after surgery. | 24 hours |
| Patient post-operative nausea and vomiting score using a 4 point scale | The instrument consists of 4 numbered points ( 0 to 3) each of which represent a different level of nausea for the patient. The scale ranges as follows: 0 = No Nausea, 1 = presence of nausea without vomiting, 2 = mild to moderate vomiting (not requiring treatment), 3 = severe vomiting (treatment required). This is assessed at 24 hours after surgery. | 24 hours |
| Patient post-operative pruritis Score using a 2 point scale | The instrument consists of 3 numbered points ( 0 to 2) each of which represent a different level of pruritus for the patient. The scale ranges as follows: 0 = no pruritus, 1 = mild to moderate pruritus (not requiring treatment), 2 = severe pruritus (treatment required). This is assessed at 24 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| The Impact of the patients pain on their activity measured using an 11 point scale | The instrument consists of 11 numbered points ( 0 to 10) each of which represent a different levels of interference with the patients activity since surgery. The scale ranges from 0= DID NOT INTERFERE up to 10= COMPLETELY INTERFERED. This is assessed at 24 hours after surgery. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Pre-operative:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Chetty, FCA(SA) | University of Witwatersrand, South Africa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rahima Moosa Mother and Child Hospital | Johannesburg | Gauteng | 2000 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42332552 | Derived | Chetty S, Paruk F, Kamerman P. Low-dose intrathecal morphine versus intrathecal fentanyl for post-caesarean analgesia in a resource-constrained setting: a pragmatic randomised trial. BMC Anesthesiol. 2026 Jun 23. doi: 10.1186/s12871-026-04034-0. Online ahead of print. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D005283 | Fentanyl |
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Morphine50 | Drug | 50mcg added to the spinal anaesthetic |
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| Fentanyl | Drug | 25mcg Fentanyl added to the spinal anaesthetic |
|
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| Hyperbaric Bupivicaine | Drug | 1.8ml 0.5% spinal bupivicaine with dextrose |
|
|
| Indomethacin | Drug | 100mg Indomethacin suppository |
|
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| 24 hours |
| Patient respiratory rate measured by counting the respiratory rate over a one minute period | The patients respiratory rate will be counted by the investigator at the time of evaluation at 24hours after surgery. The resulted will be documented as a rate per minute. | 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |