Obstetric PainPhase 2/3NCT03652116
Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief
A Phase 2/3 study testing Wound infiltration by Bupivacaine and Wound infiltration by Pethidine in people with Obstetric Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obstetric Pain
- What is being tested?
- Wound infiltration by Bupivacaine and Wound infiltration by Pethidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Apr 2017to 1 Aug 2018
- Phase
- Phase 2/3
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mode of delivery: Cesarean section.
- Gestational age: 37-40 weeks.
- Type of anaesthesia: Spinal anaesthesia.
- No past history of any medical disorder or other medical complications during pregnancy.
Who cannot join
- Women with known hypersensitivity to bupivacaine or pethidine.
- Women delivered vaginally.
- Women delivered under general anaesthesia.
- Women with known neurological or psychological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subrectal and Subcutaneous Wound Infiltration With Bupivacaine Versus Pethidine for Postcesarean Section Pain Relief: a Randomized Clinical Trial
The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief.
- Conditions
- Obstetric Pain
- Being tested
- Wound infiltration by Bupivacaine, Wound infiltration by Pethidine
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound infiltration by BupivacaineDrug
Subcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound
Wound infiltration by PethidineDrug
Subcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Group | Active comparator | Patients delivered by cesarean section followed by wound infiltration by bupivacaine. Receives: Drug: Wound infiltration by Bupivacaine |
| Pethidine Group | Active comparator | Patients delivered by cesarean section followed by wound infiltration by pethidine. Receives: Drug: Wound infiltration by Pethidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative wound pain: VAS
Postoperative wound pain will be assessed using visual analogous scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Mean values will be calculated and compared between the three groups
Measured: first 24 hours postoperatively
Secondary outcomes (4)
Total dose of opioid drugs needed
Total dose of extra opioid drugs needed to achieve postoperative analgesia
Measured: first 24 hours postoperatively
Incidence of nausea and vomiting
Number of patients experiencing nausea and vomiting
Measured: first 24 hours postoperatively
Incidence of urine retention
Number of patients experiencing urinary retention
Measured: first 24 hours postoperatively
Incidence of hypotension
Number of patients experiencing hypotension
Measured: first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start21 Apr 2017
- Primary completion10 Jun 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to local infiltration of cesarean section wound with either bupivacaine or pethidine; with follow up of postoperative pain relief.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Safwat, Ain Shams University
- Investigators
- Mohamed Samy, MD, Study director, M Samy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652116
- Sponsor's protocol ID
- PostCSLA
- Status last verified
- Aug 2018
- First submitted
- 28 Aug 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subrectal and Subcutaneous Wound Infiltration With Bupivacaine Versus Pethidine for Postcesarean Section Pain Relief: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03652116
- Acronym / sponsor ID
- PostCSLA
- Conditions
- Obstetric Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 29 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.
The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to local infiltration of cesarean section wound with either bupivacaine or pethidine; with follow up of postoperative pain relief.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Group | Active comparator | Drug: Wound infiltration by BupivacainePatients delivered by cesarean section followed by wound infiltration by bupivacaine. |
| Pethidine Group | Active comparator | Drug: Wound infiltration by PethidinePatients delivered by cesarean section followed by wound infiltration by pethidine. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mode of delivery: Cesarean section.
- Gestational age: 37-40 weeks.
- Type of anaesthesia: Spinal anaesthesia.
- No past history of any medical disorder or other medical complications during pregnancy.
Key exclusion criteria (4 listed)
- Women with known hypersensitivity to bupivacaine or pethidine.
- Women delivered vaginally.
- Women delivered under general anaesthesia.
- Women with known neurological or psychological disease.
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 |
|---|---|---|
| Wound infiltration by BupivacaineSubcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound | Drug | Bupivacaine Group |
| Wound infiltration by PethidineSubcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound | Drug | Pethidine Group |
Primary outcome
Postoperative wound pain: VAS
Time frame: first 24 hours postoperatively
Postoperative wound pain will be assessed using visual analogous scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Mean values will be calculated and compared between the three groups
4 secondary outcomes
Total dose of opioid drugs needed
Time frame: first 24 hours postoperatively
Incidence of nausea and vomiting
Time frame: first 24 hours postoperatively
Incidence of urine retention
Time frame: first 24 hours postoperatively
Incidence of hypotension
Time frame: first 24 hours postoperatively
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 31 Aug 2018.
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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.
Mohamed Samy, MD study director
M Samy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Wound infiltration by Bupivacaine and Wound infiltration by Pethidine in people with Obstetric Pain, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 4 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 31 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Postoperative wound pain: VAS (time frame: first 24 hours postoperatively). 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 31 Aug 2018.