Pain ManagementNCT01764048
To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand
A study testing Fix protocol and medications following demand protocol in people with Pain Management and Cesarean Section, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Cesarean Section
- What is being tested?
- Fix protocol and medications following demand protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Jun 2014
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women that underwent cesarean section
Who cannot join
- Women suffering from chronic pain
- Women using chronic pain medications
- Allergy to any drug used in the study
- Women underwent general anesthesia during the surgery
- women with elevated liver enzymes
Trial locations and contacts
1 site in 1 country.
Israel1 site
Departement of obstetric and gynecology, HaEmek medical center
Afula, 18101
About this study
Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request).
The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses).
The protocols will be used for the first 48 hours following surgery.
- Conditions
- Pain Management, Cesarean Section
- Being tested
- Fix protocol, medications following demand protocol
- Keywords
- pain management, cesarean section
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fix protocolDrug
Please see arm description
medications following demand protocolDrug
Please see arm description
| Study group | Role | What they receive |
|---|---|---|
| Fix protocol | Experimental | During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication):
At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams
After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams).
After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams.
Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day.
The total amount of paracetamol is limited to 4 gr per day. Receives: Drug: Fix protocol |
| medications following demand protocol | Experimental | The same combinations will be given as in the fixed protocol however only after patient request Receives: Drug: medications following demand protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of pain management
Pain sensation will be assessed using the VAS scale (visual analog scale) for measurement of acute pain
Measured: during 48 hours from surgery
Secondary outcomes (5)
adverse effect of the medications given in each protocol
Measured: during 48 hours following surgery
to compare the amount of breastfeeding between 2 groups
Measured: following the week after surgery
The number of times that pain medications were given in each study group
Measured: during 48 hours following surgery
The necessity of additional medications (rescue doses)
Measured: During 48 hours after surgery
Patient satisfaction
Each patient will fill in a satisfaction questioner which is given 48 hours after surgery
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionJan 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764048
- Sponsor's protocol ID
- 0120-12-EMC
- Status last verified
- Jan 2016
- First submitted
- 2 Jan 2013
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand
- ClinicalTrials.gov ID
- NCT01764048
- Acronym / sponsor ID
- 0120-12-EMC
- Conditions
- Pain Management, Cesarean Section
- Keywords
- pain management, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Jan 2013 (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.
Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request).
The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses).
The protocols will be used for the first 48 hours following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fix protocol | Experimental | Drug: Fix protocolDuring 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication): At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams). After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams. Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day. The total amount of paracetamol is limited to 4 gr per day. |
| medications following demand protocol | Experimental | Drug: medications following demand protocolThe same combinations will be given as in the fixed protocol however only after patient request |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women that underwent cesarean section
Key exclusion criteria (5 listed)
- Women suffering from chronic pain
- Women using chronic pain medications
- Allergy to any drug used in the study
- Women underwent general anesthesia during the surgery
- women with elevated liver enzymes
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 |
|---|---|---|
| Fix protocolPlease see arm description | Drug | Fix protocol |
| medications following demand protocolPlease see arm description | Drug | medications following demand protocol |
Primary outcome
The efficacy of pain management
Time frame: during 48 hours from surgery
Pain sensation will be assessed using the VAS scale (visual analog scale) for measurement of acute pain
5 secondary outcomes
adverse effect of the medications given in each protocol
Time frame: during 48 hours following surgery
to compare the amount of breastfeeding between 2 groups
Time frame: following the week after surgery
The number of times that pain medications were given in each study group
Time frame: during 48 hours following surgery
The necessity of additional medications (rescue doses)
Time frame: During 48 hours after surgery
Patient satisfaction
Time frame: 48 hours after surgery
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 8 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fix protocol and medications following demand protocol in people with Pain Management and Cesarean Section, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 5 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 8 Jan 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 Israel. 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.
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?
The efficacy of pain management (time frame: during 48 hours from surgery). 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 8 Jan 2016.