Postoperative Cesarean Delivery PainEarly Phase 1NCT02285491
Local Anesthetic Injection Into Both Angles of the Rectus Sheath Incision
A Early Phase 1 study testing 10ml of bupivacaine 0.5% in people with Postoperative Cesarean Delivery Pain, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Local anesthetic will be injected into both angles of the rectus sheath incision in an attempt to block sensory nerves in this area that cause the sensation of pain from lscs wound. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cesarean Delivery Pain
- What is being tested?
- 10ml of bupivacaine 0.5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2014to Nov 2015
- Phase
- Early Phase 1
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients booked for lscs
- primisection
- singleton pregnancy
Who cannot join
- emergency cesarean section
- bleeding tendency
- hypersensitivity to local anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Local Anesthetic Injection Into Both Angles of the Rectus Sheath Incision for Postoperative Cesarean Delivery Analgesia.
Local anesthetic will be injected into both angles of the rectus sheath incision in an attempt to block sensory nerves in this area that cause the sensation of pain from lscs wound.
- Conditions
- Postoperative Cesarean Delivery Pain
- Being tested
- 10ml of bupivacaine 0.5%, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10ml of bupivacaine 0.5%Drug
This is a local anesthetic that will be used to block the ilioinguinal nerve to alleviate pain at the wound site after lscs
PlaceboDrug
Also called saline
10 ml of saline will be injected as a placebo and the investigator and the patient and the data assessor are all blinded to what the patients received.
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine group | Experimental | This is the group of patients that will receive 10ml of bupivacaine 0.5% injection in both angles of the rectus sheath incision Receives: Drug: 10ml of bupivacaine 0.5% |
| saline group | Placebo comparator | This group will receive saline injections as placebo into both angles of the rectus sheath incision Receives: Drug: Placebo |
| bupivacaine and saline group | Experimental | This group will receive saline injection in one angle and 10ml of bupivacaine 0.5% injection in the opposite angle. Receives: Drug: 10ml of bupivacaine 0.5%; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment during rest and ambulation by visual analogue scale
Measured: for 24 hours after lscs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cesarean Delivery 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohammed elsafty, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285491
- Sponsor's protocol ID
- els7680
- Status last verified
- Feb 2016
- First submitted
- 5 Nov 2014
- Last updated
- 9 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Local Anesthetic Injection Into Both Angles of the Rectus Sheath Incision for Postoperative Cesarean Delivery Analgesia.
- ClinicalTrials.gov ID
- NCT02285491
- Acronym / sponsor ID
- els7680
- Conditions
- Postoperative Cesarean Delivery Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Nov 2014 (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.
Local anesthetic will be injected into both angles of the rectus sheath incision in an attempt to block sensory nerves in this area that cause the sensation of pain from lscs wound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bupivacaine group | Experimental | Drug: 10ml of bupivacaine 0.5%This is the group of patients that will receive 10ml of bupivacaine 0.5% injection in both angles of the rectus sheath incision |
| saline group | Placebo comparator | Drug: PlaceboThis group will receive saline injections as placebo into both angles of the rectus sheath incision |
| bupivacaine and saline group | Experimental | Drug: 10ml of bupivacaine 0.5%, Drug: PlaceboThis group will receive saline injection in one angle and 10ml of bupivacaine 0.5% injection in the opposite angle. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients booked for lscs
- primisection
- singleton pregnancy
Key exclusion criteria (3 listed)
- emergency cesarean section
- bleeding tendency
- hypersensitivity to local anesthetic
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 |
|---|---|---|
| 10ml of bupivacaine 0.5%This is a local anesthetic that will be used to block the ilioinguinal nerve to alleviate pain at the wound site after lscs | Drug | bupivacaine and saline group, bupivacaine group |
| PlaceboAlso: saline10 ml of saline will be injected as a placebo and the investigator and the patient and the data assessor are all blinded to what the patients received. | Drug | bupivacaine and saline group, saline group |
Primary outcome
Pain assessment during rest and ambulation by visual analogue scale
Time frame: for 24 hours after lscs
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 Feb 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 Early Phase 1 study testing 10ml of bupivacaine 0.5% in people with Postoperative Cesarean Delivery Pain, run by Ain Shams Maternity Hospital 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 3 inclusion and 3 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 Feb 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 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Pain assessment during rest and ambulation by visual analogue scale (time frame: for 24 hours after lscs). 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 9 Feb 2016.