Pregnancy, Ceasarian Section, AnaesthesiaPhase 3NCT03263689
Transversus Abdominis Plane Block Versus Spinal Morphine After Caesarean Section : A Comparison Study
A Phase 3 study testing Intrathecal morphine in people with Pregnancy, Ceasarian Section, Anaesthesia, run by Mbarara University of Science and Technology.
Trial summary
Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Ceasarian Section, Anaesthesia
- What is being tested?
- Intrathecal morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2014to 20 Jun 2016
- Phase
- Phase 3
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between the age of 18-45;
- Greater than 50 kilograms in weight;
- Routine spinal anesthetic without sedation for an uncomplicated caesarean delivery via a low, transverse abdominal incision (Pfannenstiel);
- In good health with no major medical problems including gastric ulcers, liver or renal dysfunction
- Able to communicate freely with a provided non-family member interpreter fluent in the patient's language so that informed consent may be obtained
Who cannot join
- Patients with allergies to bupivacaine, paracetamol, or diclofenac;
- Patients undergoing a surgical approach is other than a low, transverse abdominal incision (Pfannenstiel);
- Pre-eclampsia, uterine rupture, placental abruption with this pregnancy;
- Prior complicated abdominal surgery;
- Medical history of gastric ulcers, liver or kidney dysfunction; and
- Patient refusal to be involved in the study. Failure to attain informed consent from the patient due to age or level of consciousness
- Voluntary or involuntary withdraw from the study
- Referral to another health centre or Hospital for further management.
About this study
Official title: The Analgesic Effects of Intrathecal Morphine in Comparison to Ultrasound-guided Transversus Abdominis Plane Block After Cesarean Section: a Randomized Controlled Trial at a Ugandan Regional Referral Hospital
Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Cesarean section is the most common type of major operation at our institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward staffing capacity is low, with much basic nursing care provided by families and friends of patients. The investigators conducted a study to examine the impact of ITM versus TAP block in a setting of limited formal nursing oversight.
Read the detailed description
Intrathecal morphine (ITM), administered as a part of spinal anesthesia for caesarian section, can produce significant post-operative analgesia for several hours. The Tranversus Abdominis Plane (TAP) Block can also provide prolonged post-operative pain control. A small number of published studies comparing analgesic outcomes after cesarian section with ITM or TAP block have reported variable results.Moreover, these studies have been conducted in countries with extensive post-operative nursing care.
Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Cesarean section is the most common type of major operation at our institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward staffing capacity is low, with much basic nursing care provided by families and friends of patients. The investigators conducted a study to examine the impact of ITM versus TAP block in a setting of limited formal nursing oversight.
- Being tested
- Intrathecal morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphineDrug
Also called Intrathecal
ITM group were given 100 micrograms of preservative-free morphine in addition to the local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | ITM group were given
1. Local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia
2. 100 micrograms of preservative-free morphine. Receives: Drug: Intrathecal morphine |
| Control | Active comparator | TAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia. Receives: Drug: Intrathecal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement
Pain measurement using the numerical rating scale (NRS).
Measured: at 8 hours after intervention
Pain measurement
Pain measurement using the numerical rating scale (NRS).
Measured: at 16 hours after intervention
Pain measurement
Pain measurement using the numerical rating scale (NRS)
Measured: at 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start15 Mar 2014
- Primary completion20 Jun 2016
- Study completion20 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, Ceasarian Section, AnaesthesiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients in the intrathecal morphine (ITM group) were given a sham block, while the patients in the TAP group were given a TAP block. Sham blocks consisted of a non-invasive ultrasound scan. A blunt needle was gently pressed on either side of the abdomen. Bilateral TAP blocks were placed after ultrasound location of the transversus abdominis and internal oblique muscles, with the injection sites in the Triangle of Petit located at the lateral edge of the mid-abdomen. Following negative aspiration for blood, the local anaesthetic (0.25% bupivacaine with 1:200000 epinephrine) was injected in the transversus abdominis plane under ultrasound visualization in 5 cc aliquots for a total volume of 15cc per side.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Kwikiriza, MD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263689
- Sponsor's protocol ID
- MUST/19/08-14
- Status last verified
- Aug 2017
- First submitted
- 16 Aug 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared after relevant permissions have been obtained
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effects of Intrathecal Morphine in Comparison to Ultrasound-guided Transversus Abdominis Plane Block After Cesarean Section: a Randomized Controlled Trial at a Ugandan Regional Referral Hospital
- ClinicalTrials.gov ID
- NCT03263689
- Acronym / sponsor ID
- MUST/19/08-14
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Mar 2014 (actual)
- Primary completion
- 20 Jun 2016 (actual)
- Study completion
- 20 Jun 2016 (actual)
- First posted
- 28 Aug 2017 (actual)
- 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.
Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Cesarean section is the most common type of major operation at our institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward staffing capacity is low, with much basic nursing care provided by families and friends of patients. The investigators conducted a study to examine the impact of ITM versus TAP block in a setting of limited formal nursing oversight.
Detailed description
Intrathecal morphine (ITM), administered as a part of spinal anesthesia for caesarian section, can produce significant post-operative analgesia for several hours. The Tranversus Abdominis Plane (TAP) Block can also provide prolonged post-operative pain control. A small number of published studies comparing analgesic outcomes after cesarian section with ITM or TAP block have reported variable results.Moreover, these studies have been conducted in countries with extensive post-operative nursing care.
Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Cesarean section is the most common type of major operation at our institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward staffing capacity is low, with much basic nursing care provided by families and friends of patients. The investigators conducted a study to examine the impact of ITM versus TAP block in a setting of limited formal nursing oversight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patients in the intrathecal morphine (ITM group) were given a sham block, while the patients in the TAP group were given a TAP block. Sham blocks consisted of a non-invasive ultrasound scan. A blunt needle was gently pressed on either side of the abdomen. Bilateral TAP blocks were placed after ultrasound location of the transversus abdominis and internal oblique muscles, with the injection sites in the Triangle of Petit located at the lateral edge of the mid-abdomen. Following negative aspiration for blood, the local anaesthetic (0.25% bupivacaine with 1:200000 epinephrine) was injected in the transversus abdominis plane under ultrasound visualization in 5 cc aliquots for a total volume of 15cc per side.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Intrathecal morphineITM group were given 1. Local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia 2. 100 micrograms of preservative-free morphine. |
| Control | Active comparator | Drug: Intrathecal morphineTAP group were given only local anaesthesia (plain hyperbaric bupivacaine 10 mgs) during the spinal anaesthesia. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between the age of 18-45;
- Greater than 50 kilograms in weight;
- Routine spinal anesthetic without sedation for an uncomplicated caesarean delivery via a low, transverse abdominal incision (Pfannenstiel);
- In good health with no major medical problems including gastric ulcers, liver or renal dysfunction
- Able to communicate freely with a provided non-family member interpreter fluent in the patient's language so that informed consent may be obtained
Key exclusion criteria (8 listed)
- Patients with allergies to bupivacaine, paracetamol, or diclofenac;
- Patients undergoing a surgical approach is other than a low, transverse abdominal incision (Pfannenstiel);
- Pre-eclampsia, uterine rupture, placental abruption with this pregnancy;
- Prior complicated abdominal surgery;
- Medical history of gastric ulcers, liver or kidney dysfunction; and
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 |
|---|---|---|
| Intrathecal morphineAlso: IntrathecalITM group were given 100 micrograms of preservative-free morphine in addition to the local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia | Drug | Control, Intervention |
Primary outcome
Pain measurement
Time frame: at 8 hours after intervention
Pain measurement using the numerical rating scale (NRS).
Pain measurement
Time frame: at 16 hours after intervention
Pain measurement using the numerical rating scale (NRS).
Pain measurement
Time frame: at 24 hours after intervention
Pain measurement using the numerical rating scale (NRS)
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 28 Aug 2017.
- Individual participant dataSharing planned: Undecided. Data will be shared after relevant permissions have been obtained
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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.
Andrew Kwikiriza, MD principal investigator
Mbarara University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intrathecal morphine in people with Pregnancy, Ceasarian Section, Anaesthesia, run by Mbarara University of Science and Technology.
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 5 inclusion and 8 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 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain measurement (time frame: at 8 hours after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2017.