Post Operative PainPhase 4CaBuMorphNCT02456142
CAUDAL BUPIVACAINE VERSUS INTRAVENOUS MORPHINE ON TIME TO FIRST ANALGESIC REQUIREMENT
A Phase 4 study testing caudal bupivacaine and intravenous morphine in people with Post Operative Pain, run by Makerere University at 1 site in Uganda.
Trial summary
Pain is a subjective sensation which in children can only be experienced and most times not expressed. Pain management in children thus falls short of their adult counterparts. Acute pain of surgery causes significant suffering and stress. Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- caudal bupivacaine and intravenous morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUganda
- Study dates
- Jul 2015to Dec 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 Up to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All American Society of Anesthesia (ASA )I and II patients aged less than 8years undergoing elective abdominal perineal and lower limb orthopedic surgery
Who cannot join
- Known hypersensitivity to opioids Known hypersensitivity to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF CAUDAL BUPIVACAINE VERSUS INTRAVENOUS MORPHINE ON TIME TO FIRST ANALGESIC REQUIREMENT IN PEDIATRIC SURGICAL PATIENTS; A RANDOMISED CONTROLLED TRIAL.
Pain is a subjective sensation which in children can only be experienced and most times not expressed. Pain management in children thus falls short of their adult counterparts. Acute pain of surgery causes significant suffering and stress. In children, pain management has lagged behind because of the belief that children's pain receptors are less well developed than their adult counterparts. However this has been proven to be false as development of pain receptors has been shown by 26th week of gestation. Caudal analgesia with plain bupivacaine has been used for effective post operative analgesia. Resources sometimes limit acquisition of additives to bupivacaine to be delivered into the intrathecal space.
The fear of pharmacological adverse effects of opioids has restricted their use especially among the anesthesia officers who deliver the bulk of anesthesia services in Uganda and this has led to poor pain management in pediatric populations Mulago national referral hospital is a resource limited centre with regards to human resource, equipment and drugs. This is mainly due to lack of sufficient funds and large volume of patients with the nursing staff being overwhelmed by the patient capacity. Drug administration is often not done on time and continuous assessment of pain scores in children is not adequate resulting in poor post operative pain management. Pain control thus will depend on analgesia provided at the time of operation creating a need for prolonged pain control measures.
Studies done have compared intravenous morphine administration versus caudal analgesia and are mostly focused of sub umbilical surgery however none has been done in our setting. Bupivacaine and morphine are now more readily available and can be used for post operative analgesia. However studies on the timing to the next analgesic requirement have not been compared/done in Mulago national referral hospital.
Read the detailed description
Patients will be wheeled into the operating theatre.
- Anaesthesia will be induced using an inhalation anaesthetic (sevoflurane) and intravenous anaesthetic using propofol or thiopental for the older children (3 years and above).
- Maintenance of anaesthesia will be done using either inhalation anaesthetic (sevoflurane)
- Intra-operative analgesia will be maintained with intravenous fentanyl given at the start of surgery and hourly for surgeries longer than one hour.
- Monitoring intra and post operatively will be done with WHO standard monitoring. (Blood pressure, heart rate, saturation, temperature, ECG, End tidal carbon dioxide).
- The intervention will be given at the end of surgery after the last stitch has been placed with patient receiving either caudal bupivacaine or intravenous morphine.
- to receive a caudal the baby will be placed in the left lateral position knees and hips flexed
- The skin over the coccyx and sacrum will be cleansed with povidone-iodine solution and alcohol.
- After palpation of the sacral cornua, a 22- or 23-gauge needle will be placed into the sacral hiatus to identify the epidural space by loss of resistance as the needle passes through the sacral ligament.
- Aspiration will be done to check for cerebrospinal fluid or blood, then a test dose is administered to rule out intravenous injection then the drug caudal bupivacaine will be injected.
- The patients' pain scores will be assessed by the research assistant in the post anaesthesia care unit after 30 minutes before being discharged to their parent wards and hourly after the intervention is given.
- monitoring of pulse rate and saturation on the ward will be done with a pulse oximeter.
- On the ward the pain scores will be assessed every hour by the research assistant and time to a pain score of 4 recorded
- The pain scores and the time to the next analgesic requirement will be recorded and continuation of analgesia given with intravenous paracetamol.
The crying, requires oxygen, increased vital signs, expression, sleeplessness (CRIES) pain tool will be used to score pain in neonates and the Face, Legs, Activity, Cry and Consolability (FLACC) pain score used in children above 2 months. Analgesic requirement will be given if child found to be in pain.
- Conditions
- Post Operative Pain
- Being tested
- caudal bupivacaine, intravenous morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal bupivacaineDrug
Also called BUPICAN Heavy
intravenous morphineDrug
| Study group | Role | What they receive |
|---|---|---|
| caudal bupivacaine | Experimental | 1ml/kg of 0.125% caudal bupivacaine given over 2 minutes will be given at the end of surgery Receives: Drug: caudal bupivacaine |
| intravenous morphine | Active comparator | 0.05mg/kg intravenous morphine given over 5 minutes Receives: Drug: intravenous morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first analgesic requirement
time from intervention to pain score of 4
Measured: 24 hours
Post- operative pain scores of the patients using age appropriate scales.
comparing the pain scores of the patients using the FLACC and the CRIES pain tools
Measured: 24 hours
Secondary outcomes (1)
Adverse effects reactions of the intravenous morphine analgesia and caudal analgesia
watch for respiratory depression,anaphylaxis
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 posted28 May 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EZRA MUGISHA, MBChB, Principal investigator, makerere university college of health sciences department of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456142
- Sponsor's protocol ID
- 206005358
- Acronym
- CaBuMorph
- Status last verified
- May 2015
- First submitted
- 25 May 2015
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF CAUDAL BUPIVACAINE VERSUS INTRAVENOUS MORPHINE ON TIME TO FIRST ANALGESIC REQUIREMENT IN PEDIATRIC SURGICAL PATIENTS; A RANDOMISED CONTROLLED TRIAL.
- ClinicalTrials.gov ID
- NCT02456142
- Acronym / sponsor ID
- CaBuMorph / 206005358
- Conditions
- Post Operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 May 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.
Pain is a subjective sensation which in children can only be experienced and most times not expressed. Pain management in children thus falls short of their adult counterparts. Acute pain of surgery causes significant suffering and stress. In children, pain management has lagged behind because of the belief that children's pain receptors are less well developed than their adult counterparts. However this has been proven to be false as development of pain receptors has been shown by 26th week of gestation. Caudal analgesia with plain bupivacaine has been used for effective post operative analgesia. Resources sometimes limit acquisition of additives to bupivacaine to be delivered into the intrathecal space.
The fear of pharmacological adverse effects of opioids has restricted their use especially among the anesthesia officers who deliver the bulk of anesthesia services in Uganda and this has led to poor pain management in pediatric populations Mulago national referral hospital is a resource limited centre with regards to human resource, equipment and drugs. This is mainly due to lack of sufficient funds and large volume of patients with the nursing staff being overwhelmed by the patient capacity. Drug administration is often not done on time and continuous assessment of pain scores in children is not adequate resulting in poor post operative pain management. Pain control thus will depend on analgesia provided at the time of operation creating a need for prolonged pain control measures.
Studies done have compared intravenous morphine administration versus caudal analgesia and are mostly focused of sub umbilical surgery however none has been done in our setting. Bupivacaine and morphine are now more readily available and can be used for post operative analgesia. However studies on the timing to the next analgesic requirement have not been compared/done in Mulago national referral hospital.
Detailed description
Patients will be wheeled into the operating theatre.
- Anaesthesia will be induced using an inhalation anaesthetic (sevoflurane) and intravenous anaesthetic using propofol or thiopental for the older children (3 years and above).
- Maintenance of anaesthesia will be done using either inhalation anaesthetic (sevoflurane)
- Intra-operative analgesia will be maintained with intravenous fentanyl given at the start of surgery and hourly for surgeries longer than one hour.
- Monitoring intra and post operatively will be done with WHO standard monitoring. (Blood pressure, heart rate, saturation, temperature, ECG, End tidal carbon dioxide).
- The intervention will be given at the end of surgery after the last stitch has been placed with patient receiving either caudal bupivacaine or intravenous morphine.
- to receive a caudal the baby will be placed in the left lateral position knees and hips flexed
- The skin over the coccyx and sacrum will be cleansed with povidone-iodine solution and alcohol.
- After palpation of the sacral cornua, a 22- or 23-gauge needle will be placed into the sacral hiatus to identify the epidural space by loss of resistance as the needle passes through the sacral ligament.
- Aspiration will be done to check for cerebrospinal fluid or blood, then a test dose is administered to rule out intravenous injection then the drug caudal bupivacaine will be injected.
- The patients' pain scores will be assessed by the research assistant in the post anaesthesia care unit after 30 minutes before being discharged to their parent wards and hourly after the intervention is given.
- monitoring of pulse rate and saturation on the ward will be done with a pulse oximeter.
- On the ward the pain scores will be assessed every hour by the research assistant and time to a pain score of 4 recorded
- The pain scores and the time to the next analgesic requirement will be recorded and continuation of analgesia given with intravenous paracetamol.
The crying, requires oxygen, increased vital signs, expression, sleeplessness (CRIES) pain tool will be used to score pain in neonates and the Face, Legs, Activity, Cry and Consolability (FLACC) pain score used in children above 2 months. Analgesic requirement will be given if child found to be in pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caudal bupivacaine | Experimental | Drug: caudal bupivacaine1ml/kg of 0.125% caudal bupivacaine given over 2 minutes will be given at the end of surgery |
| intravenous morphine | Active comparator | Drug: intravenous morphine0.05mg/kg intravenous morphine given over 5 minutes |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All American Society of Anesthesia (ASA )I and II patients aged less than 8years undergoing elective abdominal perineal and lower limb orthopedic surgery
Key exclusion criteria (1 listed)
- Known hypersensitivity to opioids Known hypersensitivity to local anesthetics
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 |
|---|---|---|
| caudal bupivacaineAlso: BUPICAN Heavy | Drug | caudal bupivacaine |
| intravenous morphine | Drug | intravenous morphine |
Primary outcome
time to first analgesic requirement
Time frame: 24 hours
time from intervention to pain score of 4
Post- operative pain scores of the patients using age appropriate scales.
Time frame: 24 hours
comparing the pain scores of the patients using the FLACC and the CRIES pain tools
1 secondary outcome
Adverse effects reactions of the intravenous morphine analgesia and caudal analgesia
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 11 Apr 2016.
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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.
EZRA MUGISHA, MBChB principal investigator
makerere university college of health sciences department of anesthesia
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 caudal bupivacaine and intravenous morphine in people with Post Operative Pain, run by Makerere University at 1 site in Uganda.
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 1 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 11 Apr 2016. 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 Uganda. 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?
time to first analgesic requirement (time frame: 24 hours). The study lists 2 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 11 Apr 2016.