Intrathecal Opioid Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Post-operative analgesic requirements at two time points (12 hours and 24 hours) after surgery Pain scores at two time points (12 hours and 24 hours) after surgery Sedation scores at two time points (12 hours and 24 hours) after surgery Post-operative nausea scores at two time points (12 hours and 24 hours) after surgery Post-operative pruritis scores at two time points (12 hours and 24 hours) after surgery To determine the impact that the patients' post-operative pain has on their activities in the first 24 hours after surgery

Official Title
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An Investigation of the Influence of Different Intrathecal Opioids on the Post-operative Pain Experiences of Woman at Rahima Moosa Mother and Child Hospital

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Morphine100
* Drug: Morphine50
* Drug: Fentanyl
* Drug: Hyperbaric Bupivicaine
* Drug: Indomethacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients > 18years having caesarean section surgery under single shot spinal neuraxial anaesthesia at Rahima Moosa Mother and Child Hospital 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: Patients who have babies that require additional care, for a prolonged period, after birth eg. Neonatal ICU admission for ≥ 12hours or congenital abnormalities Patients who require ICU or High care admission postoperatively for any intra-operative complications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine100<br>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 | Drug: Morphine100<br>* 100mcg added to the spinal anaesthetic<br>* Other names: Morphine 100 mcg;Drug: Hyperbaric Bupivicaine<br>* 1.8ml 0.5% spinal bupivicaine with dextrose<br>* Other names: Spinal Bupivicaine;Drug: Indomethacin<br>* 100mg Indomethacin suppository<br>* Other names: Indomethacin Suppository;|
| Active Comparator: Morphine50<br>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 | Drug: Morphine50<br>* 50mcg added to the spinal anaesthetic<br>* Other names: Morphine 50mcg;Drug: Hyperbaric Bupivicaine<br>* 1.8ml 0.5% spinal bupivicaine with dextrose<br>* Other names: Spinal Bupivicaine;Drug: Indomethacin<br>* 100mg Indomethacin suppository<br>* Other names: Indomethacin Suppository;|
| Active Comparator: Fentanyl25<br>1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space | Drug: Fentanyl<br>* 25mcg Fentanyl added to the spinal anaesthetic<br>* Other names: Fentanyl 25mcg;Drug: Hyperbaric Bupivicaine<br>* 1.8ml 0.5% spinal bupivicaine with dextrose<br>* Other names: Spinal Bupivicaine;Drug: Indomethacin<br>* 100mg Indomethacin suppository<br>* Other names: Indomethacin Suppository;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |