Pain, PostoperativePhase 4NCT02274974
Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine
A Phase 4 study testing Lidocaine and lidocaine and Epinephrine in people with Pain, Postoperative, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Study to compare between efficacy of post-caesarean section infiltration with lidocaine and epinephrine versus lidocaine only to reduce post-incisional pain. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Lidocaine and lidocaine and Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2014to Apr 2015
- 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 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing caesarean delivery under General anesthesia for various indications.
- Women refuse spinal anesthesia.
Who cannot join
- Known or suspected sensitivity to local anesthesia.
- Medical disorders induced by pregnancy (Pre-eclamptic toxemia, gestational diabetes mellitus, Hepatic diseases, homeostatic disorder)
- Medical disorders aggravated by pregnancy (cardiovascular disease, pulmonary disease, renal disease, neurological disease, metabolic or infectious diseases).
- Women who hemo-dynamically unstable.
- Lack of adequate verbal communication.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;
Cairo, 11511
About this study
Official title: Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;Randomized Controlled Trial.
Study to compare between efficacy of post-caesarean section infiltration with lidocaine and epinephrine versus lidocaine only to reduce post-incisional pain.
Read the detailed description
assessment of adding of epinephrine to lidocaine as local infiltrator to post-caesarean section wound in prolongation of its anaesthetic effect.
- Conditions
- Pain, Postoperative
- Being tested
- Lidocaine, lidocaine and Epinephrine
- Keywords
- incisional, infiltration, cs, lidocaine, epinephrine, Adverse Reaction to Topical or Infiltrative Lidocaine
- Medical subject headings
- Pain, Postoperative, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called local anaesthetic agent.
•The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine.
lidocaine and EpinephrineDrug
Also called local anaesthetic agent.
The wound of C.S will be infiltrated before closure of the skin, with 20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Active comparator | 20 ml of 2% lidocaine. Receives: Drug: Lidocaine |
| lidocaine and epinephrine. | Experimental | 20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000. I.e.: by adding 1/4 from ampoule of adrenaline 1mg./1ml to bottle of lidocaine Hydrochloric acid (HCL) 2% 50 ml(20mg/ml). Receives: Drug: lidocaine and Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of first analgesic request.
Measured: 24 hours
Secondary outcomes (6)
Duration of cesarean section
Measured: 30 min to 90 min
Onset of breast breastfeeding
Measured: 24 hours
Onset of mobilization
first time patient start moving after the section
Measured: 24 hours
Duration of hospital stay
Measured: 24 hours to 48 hours
Side effects of local infiltration of lidocaine and epinephrine
Measured: 7 days
Postoperative pyrexia
<38°c
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionApr 2015
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 Pain, PostoperativeStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMR HELMY YEHIA, Ain Shams Maternity Hospital
- Investigators
- Amr H Yhia, M.D, MRCOG, Principal investigator, Ain Shams Maternity Hospital(AinShamsMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274974
- Sponsor's protocol ID
- local infilteration of C.S
- Status last verified
- Jun 2015
- First submitted
- 21 Oct 2014
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
AbdElRhman G Ali,cairo,egypt,Post-Caerarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02274974
- Acronym / sponsor ID
- local infilteration of C.S
- Conditions
- Pain, Postoperative
- Keywords
- incisional, infiltration, cs, lidocaine, epinephrine, Adverse Reaction to Topical or Infiltrative Lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Oct 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.
Study to compare between efficacy of post-caesarean section infiltration with lidocaine and epinephrine versus lidocaine only to reduce post-incisional pain.
Detailed description
assessment of adding of epinephrine to lidocaine as local infiltrator to post-caesarean section wound in prolongation of its anaesthetic effect.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Active comparator | Drug: Lidocaine20 ml of 2% lidocaine. |
| lidocaine and epinephrine. | Experimental | Drug: lidocaine and Epinephrine20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000. I.e.: by adding 1/4 from ampoule of adrenaline 1mg./1ml to bottle of lidocaine Hydrochloric acid (HCL) 2% 50 ml(20mg/ml). |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women undergoing caesarean delivery under General anesthesia for various indications.
- Women refuse spinal anesthesia.
Key exclusion criteria (5 listed)
- Known or suspected sensitivity to local anesthesia.
- Medical disorders induced by pregnancy (Pre-eclamptic toxemia, gestational diabetes mellitus, Hepatic diseases, homeostatic disorder)
- Medical disorders aggravated by pregnancy (cardiovascular disease, pulmonary disease, renal disease, neurological disease, metabolic or infectious diseases).
- Women who hemo-dynamically unstable.
- Lack of adequate verbal communication.
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 |
|---|---|---|
| LidocaineAlso: local anaesthetic agent.•The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine. | Drug | lidocaine |
| lidocaine and EpinephrineAlso: local anaesthetic agent.The wound of C.S will be infiltrated before closure of the skin, with 20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000. | Drug | lidocaine and epinephrine. |
Primary outcome
Timing of first analgesic request.
Time frame: 24 hours
6 secondary outcomes
Duration of cesarean section
Time frame: 30 min to 90 min
Onset of breast breastfeeding
Time frame: 24 hours
Onset of mobilization
Time frame: 24 hours
Duration of hospital stay
Time frame: 24 hours to 48 hours
Side effects of local infiltration of lidocaine and epinephrine
Time frame: 7 days
Postoperative pyrexia
Time frame: 24 hours
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 25 Jun 2015.
- BackgroundAbdElRhman G Ali,cairo,egypt,Post-Caerarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine.
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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.
Amr H Yhia, M.D, MRCOG principal investigator
Ain Shams Maternity Hospital(AinShamsMH)
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 Lidocaine and lidocaine and Epinephrine in people with Pain, Postoperative, 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 2 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 25 Jun 2015. 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 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?
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?
Timing of first analgesic request. (time frame: 24 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 NCT02274974, 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 25 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.