Postoperative PainPhase 4NCT03622489
Comparing Protocols for Analgesia Following Elective Cesarean Section
A Phase 4 study testing Acetaminophen, Ibuprofen 400 mg and Dipyrone in people with Postoperative Pain and Post-Cesarean Section, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Women undergoing elective cesarian section will be assigned to 3 groups for postoperative analgesia: 1. Scheduled doses of IV acetaminophen + PO Ibuprofen 2. Scheduled doses of PO acetaminophen + PO Ibuprofen 3. "On demand" doses of acetaminophen, dipyrone and ibuprofen. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Post-Cesarean Section
- What is being tested?
- Acetaminophen, Ibuprofen 400 mg and Dipyrone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to 31 Aug 2018
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing elective cesarian section
Who cannot join
- known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson medical center
Holon
Rinat Hirsh, +97235028346, rinath@wmc.org.il
Lotem Dafna, MD
About this study
Women undergoing elective cesarian section will be assigned to 3 groups for postoperative analgesia:
- Scheduled doses of IV acetaminophen + PO Ibuprofen
- Scheduled doses of PO acetaminophen + PO Ibuprofen
- "On demand" doses of acetaminophen, dipyrone and ibuprofen.
Read the detailed description
A prospective randomised trial. Women undergoing elective cesarean section will be randomized to three groups. The treatment will be given for 48 hours after surgery. For evealuating objective pain sensation the investigators will be using the Visual Numerical Score (VNS). Demographic characteristics and information about breastfeeding and medications' side effects, will be reviewed from patients' medical scores.
Exclusion criteria: known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs.
Number of participants: 120
Treatment:
All women will receive immediately after surgery, in the recovery room:
- IV morphin 5 mg, repeat doses every 10 minutes for VNS>3
- IV Tramal 100 mg, once
After Admitted to Mternity ward:
- 1st group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and IV Acetaminophen 1 gr 14:00 hr, IV Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, IV Acetaminophen 1 gr
- 2nd group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and PO Acetaminophen 1 gr 14:00 hr, PO Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, PO Acetaminophen 1 gr
- 1st+2nd group will be given additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS>4, up to 4 times a day, at least 6 hours between doses.
Tab Tramadex 100 mg, for VNS>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses.
- 3rd group will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score:
- Tab. Acetaminophen 1 gr, for VNS 1-3, up to 4 times a day, at east 6 hours between doses.
- PO drops Dipyrone 1 gr, for VNS 4-7, or if pain persists for 1 hour after receiving Acetaminophen, up to 4 times a day, at least 6 hours between doses.
- Tab Ibuprofen 400 mg, for VNS 8-10, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 8 hours between doses.
- Conditions
- Postoperative Pain, Post-Cesarean Section
- Being tested
- Acetaminophen, Ibuprofen 400 mg, Dipyrone, Tramadol, 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.
AcetaminophenDrug
mentioned above
Ibuprofen 400 mgDrug
mentioned above
DipyroneDrug
mentioned above
TramadolDrug
Also called Tramadex
mentioned above
MorphineDrug
mentioned above
TramalDrug
mentioned above
| Study group | Role | What they receive |
|---|---|---|
| Tab ibuprofen + IV acetaminophen | Experimental | All women will receive immediately after surgery, in the recovery room:
1. IV morphin 5 mg, repeat doses every 10 minutes for VNS>3
2. IV Tramal 100 mg, once
After Admitted to Maternity ward:
- Scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and IV Acetaminophen 1 gr 14:00 hr, IV Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, IV Acetaminophen 1 gr
-Additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS>4, up to 4 times a day, at least 6 hours between doses.
Tab Tramadex 100 mg, for VNS>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses. Receives: Drug: Acetaminophen; Drug: Ibuprofen 400 mg; Drug: Tramadol; Drug: Morphine; Drug: Tramal |
| Tab Ibuprofen + Tab acetaminophen | Experimental | All women will receive immediately after surgery, in the recovery room:
1. IV morphin 5 mg, repeat doses every 10 minutes for VNS>3
2. IV Tramal 100 mg, once
After Admitted to Maternity ward:
- Scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and PO Acetaminophen 1 gr 14:00 hr, PO Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, PO Acetaminophen 1 gr
- Additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS>4, up to 4 times a day, at least 6 hours between doses.
Tab Tramadex 100 mg, for VNS>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses. Receives: Drug: Acetaminophen; Drug: Ibuprofen 400 mg; Drug: Tramadol; Drug: Morphine; Drug: Tramal |
| "On demand" analgesia | Experimental | All women will receive immediately after surgery, in the recovery room:
1. IV morphin 5 mg, repeat doses every 10 minutes for VNS>3
2. IV Tramal 100 mg, once
After Admitted to Mternity ward:
Will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score:
* Tab. Acetaminophen 1 gr, for VNS 1-3, up to 4 times a day, at east 6 hours between doses.
* PO drops Dipyrone 1 gr, for VNS 4-7, or if pain persists for 1 hour after receiving Acetaminophen, up to 4 times a day, at least 6 hours between doses.
* Tab Ibuprofen 400 mg, for VNS 8-10, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 8 hours between doses. Receives: Drug: Acetaminophen; Drug: Ibuprofen 400 mg; Drug: Dipyrone; Drug: Tramadol; Drug: Morphine; Drug: Tramal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain score 48 hours following surgery: visual numerical scale (VNS)
Using : visual numerical scale (VNS)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Mar 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
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 Postoperative 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michal Kovo, MD, Study chair, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622489
- Sponsor's protocol ID
- 0022-17-WOMC
- Status last verified
- Jun 2018
- First submitted
- 5 Aug 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dafna L, Herman HG, Ben-Zvi M, Bustan M, Sasson L, Bar J, Kovo M. Comparison of 3 protocols for analgesia control after cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2019 May;1(2):112-118. doi: 10.1016/j.ajogmf.2019.04.002. Epub 2019 Apr 8.
PubMed 33345816
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Protocols for Analgesia Following Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT03622489
- Acronym / sponsor ID
- 0022-17-WOMC
- Conditions
- Postoperative Pain, Post-Cesarean Section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 9 Aug 2018 (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.
Women undergoing elective cesarian section will be assigned to 3 groups for postoperative analgesia:
- Scheduled doses of IV acetaminophen + PO Ibuprofen
- Scheduled doses of PO acetaminophen + PO Ibuprofen
- "On demand" doses of acetaminophen, dipyrone and ibuprofen.
Detailed description
A prospective randomised trial. Women undergoing elective cesarean section will be randomized to three groups. The treatment will be given for 48 hours after surgery. For evealuating objective pain sensation the investigators will be using the Visual Numerical Score (VNS). Demographic characteristics and information about breastfeeding and medications' side effects, will be reviewed from patients' medical scores.
Exclusion criteria: known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs.
Number of participants: 120
Treatment:
All women will receive immediately after surgery, in the recovery room:
- IV morphin 5 mg, repeat doses every 10 minutes for VNS>3
- IV Tramal 100 mg, once
After Admitted to Mternity ward:
- 1st group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and IV Acetaminophen 1 gr 14:00 hr, IV Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, IV Acetaminophen 1 gr
- 2nd group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and PO Acetaminophen 1 gr 14:00 hr, PO Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, PO Acetaminophen 1 gr
- 1st+2nd group will be given additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS>4, up to 4 times a day, at least 6 hours between doses.
Tab Tramadex 100 mg, for VNS>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses.
- 3rd group will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score:
- Tab. Acetaminophen 1 gr, for VNS 1-3, up to 4 times a day, at east 6 hours between doses.
- PO drops Dipyrone 1 gr, for VNS 4-7, or if pain persists for 1 hour after receiving Acetaminophen, up to 4 times a day, at least 6 hours between doses.
- Tab Ibuprofen 400 mg, for VNS 8-10, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 8 hours between doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tab ibuprofen + IV acetaminophen | Experimental | Drug: Acetaminophen, Drug: Ibuprofen 400 mg, Drug: Tramadol, Drug: Morphine, Drug: TramalAll women will receive immediately after surgery, in the recovery room: 1. IV morphin 5 mg, repeat doses every 10 minutes for VNS>3 2. IV Tramal 100 mg, once After Admitted to Maternity ward: - Scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and IV Acetaminophen 1 gr 14:00 hr, IV Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, IV Acetaminophen 1 gr -Additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS>4, up to 4 times a day, at least 6 hours between doses. Tab Tramadex 100 mg, for VNS>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses. |
| Tab Ibuprofen + Tab acetaminophen | Experimental | Drug: Acetaminophen, Drug: Ibuprofen 400 mg, Drug: Tramadol, Drug: Morphine, Drug: TramalAll women will receive immediately after surgery, in the recovery room: 1. IV morphin 5 mg, repeat doses every 10 minutes for VNS>3 2. IV Tramal 100 mg, once After Admitted to Maternity ward: - Scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and PO Acetaminophen 1 gr 14:00 hr, PO Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, PO Acetaminophen 1 gr - Additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS>4, up to 4 times a day, at least 6 hours between doses. Tab Tramadex 100 mg, for VNS>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses. |
| "On demand" analgesia | Experimental | Drug: Acetaminophen, Drug: Ibuprofen 400 mg, Drug: Dipyrone, Drug: Tramadol, Drug: Morphine, Drug: TramalAll women will receive immediately after surgery, in the recovery room: 1. IV morphin 5 mg, repeat doses every 10 minutes for VNS>3 2. IV Tramal 100 mg, once After Admitted to Mternity ward: Will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score: * Tab. Acetaminophen 1 gr, for VNS 1-3, up to 4 times a day, at east 6 hours between doses. * PO drops Dipyrone 1 gr, for VNS 4-7, or if pain persists for 1 hour after receiving Acetaminophen, up to 4 times a day, at least 6 hours between doses. * Tab Ibuprofen 400 mg, for VNS 8-10, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 8 hours between doses. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women undergoing elective cesarian section
Key exclusion criteria (1 listed)
- known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs.
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 |
|---|---|---|
| Acetaminophenmentioned above | Drug | "On demand" analgesia, Tab Ibuprofen + Tab acetaminophen, Tab ibuprofen + IV acetaminophen |
| Ibuprofen 400 mgmentioned above | Drug | "On demand" analgesia, Tab Ibuprofen + Tab acetaminophen, Tab ibuprofen + IV acetaminophen |
| Dipyronementioned above | Drug | "On demand" analgesia |
| TramadolAlso: Tramadexmentioned above | Drug | "On demand" analgesia, Tab Ibuprofen + Tab acetaminophen, Tab ibuprofen + IV acetaminophen |
| Morphinementioned above | Drug | "On demand" analgesia, Tab Ibuprofen + Tab acetaminophen, Tab ibuprofen + IV acetaminophen |
| Tramalmentioned above | Drug | "On demand" analgesia, Tab Ibuprofen + Tab acetaminophen, Tab ibuprofen + IV acetaminophen |
Primary outcome
Average pain score 48 hours following surgery: visual numerical scale (VNS)
Time frame: 48 hours
Using : visual numerical scale (VNS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 33345816Dafna L, Herman HG, Ben-Zvi M, Bustan M, Sasson L, Bar J, Kovo M. Comparison of 3 protocols for analgesia control after cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2019 May;1(2):112-118. doi: 10.1016/j.ajogmf.2019.04.002. Epub 2019 Apr 8.
- Individual participant dataSharing planned: No
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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.
Michal Kovo, MD study chair
Wolfson Medical Center
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 Acetaminophen, Ibuprofen 400 mg and Dipyrone in people with Postoperative Pain and Post-Cesarean Section, run by Wolfson Medical Center 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 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: status not confirmed, as of the sponsor's last update on 9 Aug 2018. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lotem Dafna, MD (+972524205415, lotemdafne@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain score 48 hours following surgery: visual numerical scale (VNS) (time frame: 48 hours). 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 NCT03622489, 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 Aug 2018.