Post-operative PainPhase 4NCT02577809
Intrathecal Opioid Study
A Phase 4 study testing Morphine100, Morphine50 and Fentanyl in people with Post-operative Pain, run by University of Witwatersrand, South Africa at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Morphine100, Morphine50 and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jul 2015to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients > 18years having caesarean section surgery under single shot spinal neuraxial anaesthesia at Rahima Moosa Mother and Child Hospital
Who cannot join
- Pre-operative:
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Rahima Moosa Mother and Child Hospital
Johannesburg, Gauteng, 2000
About this study
Official title: An Investigation of the Influence of Different Intrathecal Opioids on the Post-operative Pain Experiences of Woman at Rahima Moosa Mother and Child Hospital
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.
Read the detailed description
- 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
- Conditions
- Post-operative Pain
- Being tested
- Morphine100, Morphine50, Fentanyl, Hyperbaric Bupivicaine, Indomethacin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine100Drug
Also called Morphine 100 mcg
100mcg added to the spinal anaesthetic
Morphine50Drug
Also called Morphine 50mcg
50mcg added to the spinal anaesthetic
FentanylDrug
Also called Fentanyl 25mcg
25mcg Fentanyl added to the spinal anaesthetic
Hyperbaric BupivicaineDrug
Also called Spinal Bupivicaine
1.8ml 0.5% spinal bupivicaine with dextrose
IndomethacinDrug
Also called Indomethacin Suppository
100mg Indomethacin suppository
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Morphine100; Drug: Hyperbaric Bupivicaine; Drug: Indomethacin |
| 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 Receives: Drug: Morphine50; Drug: Hyperbaric Bupivicaine; Drug: Indomethacin |
| Fentanyl25 | Active comparator | 1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space Receives: Drug: Fentanyl; Drug: Hyperbaric Bupivicaine; Drug: Indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Chetty, University of Witwatersrand, South Africa
- Investigators
- Sean Chetty, FCA(SA), Principal investigator, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577809
- Sponsor's protocol ID
- M141181
- Status last verified
- Oct 2015
- First submitted
- 10 Oct 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 42332552
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Influence of Different Intrathecal Opioids on the Post-operative Pain Experiences of Woman at Rahima Moosa Mother and Child Hospital
- ClinicalTrials.gov ID
- NCT02577809
- Acronym / sponsor ID
- M141181
- Conditions
- Post-operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morphine100 | Active comparator | Drug: Morphine100, Drug: Hyperbaric Bupivicaine, Drug: Indomethacin1.8ml 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 | Drug: Morphine50, Drug: Hyperbaric Bupivicaine, Drug: Indomethacin1.8ml 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 | Drug: Fentanyl, Drug: Hyperbaric Bupivicaine, Drug: Indomethacin1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients > 18years having caesarean section surgery under single shot spinal neuraxial anaesthesia at Rahima Moosa Mother and Child Hospital
Key exclusion criteria (7 listed)
- Pre-operative:
- Intra-operative:
- Post-operative:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine100Also: Morphine 100 mcg100mcg added to the spinal anaesthetic | Drug | Morphine100 |
| Morphine50Also: Morphine 50mcg50mcg added to the spinal anaesthetic | Drug | Morphine50 |
| FentanylAlso: Fentanyl 25mcg25mcg Fentanyl added to the spinal anaesthetic | Drug | Fentanyl25 |
| Hyperbaric BupivicaineAlso: Spinal Bupivicaine1.8ml 0.5% spinal bupivicaine with dextrose | Drug | Fentanyl25, Morphine100, Morphine50 |
| IndomethacinAlso: Indomethacin Suppository100mg Indomethacin suppository | Drug | Fentanyl25, Morphine100, Morphine50 |
Primary outcome
Opioid Analgesic Requirements measured by total morphine usage on Patient Controlled Analgesic pump
Time frame: For 24 hours after surgery
The total administered morphine dose administered to the patient through the PCA pump will be documented. This is documented at 24 hours after surgery.
Patient Pain Score measured by the Numeric Pain Rating scale
Time frame: 24 hours after surgery
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.
Patient sedation scores measured by a 4 point sedation scale
Time frame: 24 hours
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.
Patient post-operative nausea and vomiting score using a 4 point scale
Time frame: 24 hours
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.
Patient post-operative pruritis Score using a 2 point scale
Time frame: 24 hours
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.
Patient respiratory rate measured by counting the respiratory rate over a one minute period
Time frame: 24 hours
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.
1 secondary outcome
The Impact of the patients pain on their activity measured using an 11 point scale
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Derived from this study: PubMed 42332552Chetty 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Chetty, FCA(SA) principal investigator
University of Witwatersrand, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine100, Morphine50 and Fentanyl in people with Post-operative Pain, run by University of Witwatersrand, South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Analgesic Requirements measured by total morphine usage on Patient Controlled Analgesic pump (time frame: For 24 hours after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015; AzTrials last refreshed its copy on 28 Oct 2026.