Post Cesarean Pain ManagementNCT02440399
To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine
A study testing Tramadol hydrochloride, Morphine and Paracetamol in people with Post Cesarean Pain Management, 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Cesarean Pain Management
- What is being tested?
- Tramadol hydrochloride, Morphine and Paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to May 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women that underwent cesarean section with sinal anesthesia
Who cannot join
- Women who suffer from chronic pain
- Women using chronic pain medications
- Women with allergy to any drug used in the study
- Women underwent general anesthesia during the surgery
- Women who suffer from sleep apnea
- Women who suffer from obesity (BMI>40)
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- Women who suffer from severe nausea and vomiting after previous surgery
- Women who received perioperative magnesium
- Women who suffer from hypertension
- Women who suffer from renal failure
Trial locations and contacts
1 site in 1 country.
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.
Read the detailed description
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:
- Oral pain relievers' administration in fix protocol without need for patient demand
- Spinal morphine given during the spinal anesthesia in the cesarean section
- Conditions
- Post Cesarean Pain Management
- Being tested
- Tramadol hydrochloride, Morphine, Paracetamol, Diclofenac, TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol hydrochlorideDrug
Please see arm description
MorphineDrug
Please see arm description
ParacetamolDrug
DiclofenacDrug
TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)Drug
| Study group | Role | What they receive |
|---|---|---|
| Fix protocol - Oral treatment | 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: Tramadol hydrochloride; Drug: Paracetamol; Drug: Diclofenac; Drug: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG) |
| Spinal morphine | Experimental | The women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section Receives: Drug: Morphine |
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 NRS scale (numeric rating scale) for measurement of acute pain
Measured: during 48 hours from surgery
Secondary outcomes (6)
Patient satisfaction
Each patient will fill in a satisfaction questioner which is given 48 hours after surgery
Measured: 48 hours after surgery
The necessity of additional medications (rescue doses)
Measured: During 48 hours after surgery
Adverse effect of the medications given in each protocol on the mother and neonates
Measured: during 48 hours following surgery
To compare the amount of breastfeeding between 2 groups
Measured: Following the week after surgery
Total amount of pain medications required in each study group
Measured: during 48 hours following surgery and after 7 days
The efficacy of pain management during 4 days past surgery
Pain sensation will be assessed using the VAS scale
Measured: during 4 days past surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2017
- Study completionMay 2017
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 Cesarean 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, enav yefet, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440399
- Sponsor's protocol ID
- 0028-15
- Status last verified
- May 2017
- First submitted
- 7 May 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Yefet E, Nassar S, Carmeli J, Massalha M, Hasanein J, Zafran N, Rudin M, Nachum Z. Oral analgesia in fixed-time interval administration versus spinal morphine for post-Cesarean pain: a randomised controlled trial. Arch Gynecol Obstet. 2022 Apr;305(4):893-901. doi: 10.1007/s00404-021-06196-3. Epub 2021 Aug 31.
PubMed 34463805
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine
- ClinicalTrials.gov ID
- NCT02440399
- Acronym / sponsor ID
- 0028-15
- Conditions
- Post Cesarean Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 12 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.
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.
Detailed description
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:
- Oral pain relievers' administration in fix protocol without need for patient demand
- Spinal morphine given during the spinal anesthesia in the cesarean section
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fix protocol - Oral treatment | Experimental | Drug: Tramadol hydrochloride, Drug: Paracetamol, Drug: Diclofenac, Drug: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)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. |
| Spinal morphine | Experimental | Drug: MorphineThe women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women that underwent cesarean section with sinal anesthesia
Key exclusion criteria (10 listed)
- Women who suffer from chronic pain
- Women using chronic pain medications
- Women with allergy to any drug used in the study
- Women underwent general anesthesia during the surgery
- Women who suffer from sleep apnea
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 |
|---|---|---|
| Tramadol hydrochloridePlease see arm description | Drug | Fix protocol - Oral treatment |
| MorphinePlease see arm description | Drug | Spinal morphine |
| Paracetamol | Drug | Fix protocol - Oral treatment |
| Diclofenac | Drug | Fix protocol - Oral treatment |
| TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG) | Drug | Fix protocol - Oral treatment |
Primary outcome
The efficacy of pain management
Time frame: during 48 hours from surgery
Pain sensation will be assessed using the NRS scale (numeric rating scale) for measurement of acute pain
6 secondary outcomes
Patient satisfaction
Time frame: 48 hours after surgery
The necessity of additional medications (rescue doses)
Time frame: During 48 hours after surgery
Adverse effect of the medications given in each protocol on the mother and neonates
Time frame: during 48 hours following surgery
To compare the amount of breastfeeding between 2 groups
Time frame: Following the week after surgery
Total amount of pain medications required in each study group
Time frame: during 48 hours following surgery and after 7 days
The efficacy of pain management during 4 days past surgery
Time frame: during 4 days past 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 9 May 2017.
- Derived from this study: PubMed 34463805Yefet E, Nassar S, Carmeli J, Massalha M, Hasanein J, Zafran N, Rudin M, Nachum Z. Oral analgesia in fixed-time interval administration versus spinal morphine for post-Cesarean pain: a randomised controlled trial. Arch Gynecol Obstet. 2022 Apr;305(4):893-901. doi: 10.1007/s00404-021-06196-3. Epub 2021 Aug 31.
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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 Tramadol hydrochloride, Morphine and Paracetamol in people with Post Cesarean Pain Management, 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 10 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 9 May 2017. 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?
On the ClinicalTrials.gov record for NCT02440399, 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 9 May 2017.