Pain ReliefNCT00914498
The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section
A study testing Local, pre-incisional injection of 20 ml 1% xylocaine in people with Pain Relief, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
Trial summary
This study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. One hundred and twenty women will be allocated to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain Relief
- What is being tested?
- Local, pre-incisional injection of 20 ml 1% xylocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Dec 2010
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Candidates for non-emergency cesarean section
Who cannot join
- Emergency cesarean section
- Known or suspected sensitivity to local anesthetics
- Pre-eclamptic toxemia
- Deranged liver function
- Deranged hemostasis
- Lack of adequate verbal communication
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynecology, Baruch Padeh Medical Center
Poria – Neve Oved
Izhar Ben-Shlomo, MD, 972-50-6268024, izharbs@netvision.net.il
Aviva Peleg, MSc, 972-50-6267521, apeleg@poria.health.gov.il
About this study
This study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. One hundred and twenty women will be allocated to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. We will also examine possible effect of this infiltration of parameters of wound heeling and scar formation, six weeks post partum.
Read the detailed description
Among all other abdominal operations cesarean section is unique in two aspects. First, the requirement for rapid and as painless as possible recovery is not only important for the general good reasons, but there is the newborn baby, who needs maternal care. Second, in many cases the operation recurs in the same site, which may involve higher level of post operative pain.
Application of local anesthetics to the incision site have been tried for abdominal operation in several forms, ranging from pre-incision injection (1-6) through post incision injection (7 ) to indwelling catheter for protracted instillation (8-9). Where tried, these methods mostly contributed to the reduction of post operative pain and patients' satisfaction, although there is no consensus as to its efficacy. Yet, local, pre-incision injection of local anesthetics has not been tested for cesarean section.
The above not withstanding, it has been proposed that local infiltration of tissue with xylocaine may interfere with wound healing (10-11). Others suggested possible benefit due to antimicrobial activity (12) Conversely, Al- Asfour et al. (13) found no effect of topical oral application of xylocaine on experimental wounds in rabbits. Interestingly, Drucker et al. found that less collagen was deposited in healing wounds that were infiltrated with xylocaine prior to incision, while the strength of the scar was not affected (14-15).
Our proposed study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. It will also examine possible effect of this infiltration of parameters of wound heeling and scar formation.
- Conditions
- Pain Relief
- Being tested
- Local, pre-incisional injection of 20 ml 1% xylocaine
- Keywords
- Xylocaine, Casarean section, Post operative pain, Scar quality
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local, pre-incisional injection of 20 ml 1% xylocaineDrug
Local, pre-incisional injection of 20 ml 1% xylocaine
| Study group | Role | What they receive |
|---|---|---|
| Xylocaine | Experimental | Participants will receive local injection of 20 ml 1% Xylocaine to the skin incision site Receives: Drug: Local, pre-incisional injection of 20 ml 1% xylocaine |
| Controls | Placebo comparator | Participants will receive injection of 0.9% NaCl 20 ml to the incision site Receives: Drug: Local, pre-incisional injection of 20 ml 1% xylocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of post operative pain on a visual analog scale
Measured: Up to 48 hours postoperative
Secondary outcomes (1)
Appearance of operative scar, compared to previous scar
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ReliefStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Investigators
- Izhar Ben-Shlomo, MD, Principal investigator, Department of Obstetrics & Gynecology, Baruch Padeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914498
- Sponsor's protocol ID
- Xylocaine CS Scar.CTIL
- Status last verified
- Aug 2009
- First submitted
- 4 Jun 2009
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section
- ClinicalTrials.gov ID
- NCT00914498
- Acronym / sponsor ID
- Xylocaine CS Scar.CTIL
- Conditions
- Pain Relief
- Keywords
- Xylocaine, Casarean section, Post operative pain, Scar quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (estimated)
- First posted
- 5 Jun 2009 (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.
This study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. One hundred and twenty women will be allocated to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. We will also examine possible effect of this infiltration of parameters of wound heeling and scar formation, six weeks post partum.
Detailed description
Among all other abdominal operations cesarean section is unique in two aspects. First, the requirement for rapid and as painless as possible recovery is not only important for the general good reasons, but there is the newborn baby, who needs maternal care. Second, in many cases the operation recurs in the same site, which may involve higher level of post operative pain.
Application of local anesthetics to the incision site have been tried for abdominal operation in several forms, ranging from pre-incision injection (1-6) through post incision injection (7 ) to indwelling catheter for protracted instillation (8-9). Where tried, these methods mostly contributed to the reduction of post operative pain and patients' satisfaction, although there is no consensus as to its efficacy. Yet, local, pre-incision injection of local anesthetics has not been tested for cesarean section.
The above not withstanding, it has been proposed that local infiltration of tissue with xylocaine may interfere with wound healing (10-11). Others suggested possible benefit due to antimicrobial activity (12) Conversely, Al- Asfour et al. (13) found no effect of topical oral application of xylocaine on experimental wounds in rabbits. Interestingly, Drucker et al. found that less collagen was deposited in healing wounds that were infiltrated with xylocaine prior to incision, while the strength of the scar was not affected (14-15).
Our proposed study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. It will also examine possible effect of this infiltration of parameters of wound heeling and scar formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylocaine | Experimental | Drug: Local, pre-incisional injection of 20 ml 1% xylocaineParticipants will receive local injection of 20 ml 1% Xylocaine to the skin incision site |
| Controls | Placebo comparator | Drug: Local, pre-incisional injection of 20 ml 1% xylocaineParticipants will receive injection of 0.9% NaCl 20 ml to the incision site |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Candidates for non-emergency cesarean section
Key exclusion criteria (6 listed)
- Emergency cesarean section
- Known or suspected sensitivity to local anesthetics
- Pre-eclamptic toxemia
- Deranged liver function
- Deranged hemostasis
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 |
|---|---|---|
| Local, pre-incisional injection of 20 ml 1% xylocaineLocal, pre-incisional injection of 20 ml 1% xylocaine | Drug | Controls, Xylocaine |
Primary outcome
Level of post operative pain on a visual analog scale
Time frame: Up to 48 hours postoperative
1 secondary outcome
Appearance of operative scar, compared to previous scar
Time frame: 6-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
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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.
Izhar Ben-Shlomo, MD principal investigator
Department of Obstetrics & Gynecology, Baruch Padeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local, pre-incisional injection of 20 ml 1% xylocaine in people with Pain Relief, run by The Baruch Padeh Medical Center, Poriya 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 6 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 25 Aug 2009. 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. 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.
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 Izhar Ben-Shlomo, MD (972-50-6268024, izharbs@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of post operative pain on a visual analog scale (time frame: Up to 48 hours postoperative). 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 25 Aug 2009.