Postcesarean Pain ReliefPhase 2/3NCT02707081
Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief
A Phase 2/3 study testing Intravenous normal saline, Intraperitoneal normal saline and Intraperitoneal Lidocaine in people with Postcesarean Pain Relief, run by Benha University.
Trial summary
Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV) lidocaine infusion for postoperative pain control after cesarean section. Study design: prospective randomized, double-blind, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postcesarean Pain Relief
- What is being tested?
- Intravenous normal saline, Intraperitoneal normal saline and Intraperitoneal Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Dec 2015
- 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
- Singleton pregnancy, more than or equal completed 37 gestational weeks, indicated to undergo elective cesarean delivery for various indications
Who cannot join
- extreme of age (below 18 or above 40 year), uncooperative patients, women under spinal anesthesia, previous abdominal scars, including previous cesarean or myomectomy, multiple gestation, BMI >35 kg/m², chorioamnionitis, hypersensitivity or contraindications to lidocaine, bronchial asthma, bleeding diathesis, pregnancy induced-hypertension, liver or kidney diseases, diabetes mellitus, and patients with psychological disturbance, or any form of chronic pain before or during pregnancy.
About this study
Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV) lidocaine infusion for postoperative pain control after cesarean section.
Study design: prospective randomized, double-blind, placebo-controlled study. Patients and methods: Initially, 165 pregnant full-term females, indicated to be underwent elective cesarean delivery for various indications were randomized equally to either group C (control, IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV (intravenous lidocaine infusion).Five patients were excluded from each group for various reasons. The outcome measures were postoperative pain scoring, total pethidine consumption and the need for postoperative analgesia.
- Conditions
- Postcesarean Pain Relief
- Being tested
- Intravenous normal saline, Intraperitoneal normal saline, Intraperitoneal Lidocaine, Intravenous Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous normal salineDrug
Also called IV Saline
Normal saline in a volume equivalent to that used in intravenous lidocaine group
Intraperitoneal normal salineDrug
Also called IP Saline
Patients received 00 ml of saline intraperitoneally
Intraperitoneal LidocaineDrug
Also called IP Lidocaine
Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure.
Intravenous LidocaineDrug
Also called IV Lidocaine
Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control group | Placebo comparator | Saline was given both intraperitoneally and intravenously during caesarean section Receives: Drug: Intravenous normal saline; Drug: Intraperitoneal normal saline |
| Intraperitoneal instillation group | Active comparator | Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure with intravenous normal saline in a volume equivalent to that used in intravenous lidocaine group as placebo to ensure blinding. Receives: Drug: Intravenous normal saline; Drug: Intraperitoneal Lidocaine |
| Intravenous injection group | Active comparator | Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding Receives: Drug: Intraperitoneal normal saline; Drug: Intravenous Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scoring (number)
Measured: First 24 hours postoperative
Secondary outcomes (6)
The need for rescue postoperative analgesia.
Measured: First 24 hours postoperative
Total pethidine consumption in 24 hours (mg)
Measured: First 24 hours postoperative
The time to bowel sounds, hours
Measured: First 3 days postoperative
The time to start regular diet, days
Measured: First 3 days postoperative
Duration of hospital stay , days
Measured: First 3 days postoperative
Any reported side effects
Measured: First 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postcesarean Pain ReliefStudies of the same condition, open and under way.
- More trials run by Benha 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Walid Anwar Murad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707081
- Sponsor's protocol ID
- Benha 121
- Status last verified
- Mar 2016
- First submitted
- 4 Mar 2016
- Last updated
- 14 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief
- ClinicalTrials.gov ID
- NCT02707081
- Acronym / sponsor ID
- Benha 121
- Conditions
- Postcesarean Pain Relief
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Mar 2016 (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.
Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV) lidocaine infusion for postoperative pain control after cesarean section.
Study design: prospective randomized, double-blind, placebo-controlled study. Patients and methods: Initially, 165 pregnant full-term females, indicated to be underwent elective cesarean delivery for various indications were randomized equally to either group C (control, IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV (intravenous lidocaine infusion).Five patients were excluded from each group for various reasons. The outcome measures were postoperative pain scoring, total pethidine consumption and the need for postoperative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo control group | Placebo comparator | Drug: Intravenous normal saline, Drug: Intraperitoneal normal salineSaline was given both intraperitoneally and intravenously during caesarean section |
| Intraperitoneal instillation group | Active comparator | Drug: Intravenous normal saline, Drug: Intraperitoneal LidocainePatients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure with intravenous normal saline in a volume equivalent to that used in intravenous lidocaine group as placebo to ensure blinding. |
| Intravenous injection group | Active comparator | Drug: Intraperitoneal normal saline, Drug: Intravenous LidocainePatients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Singleton pregnancy, more than or equal completed 37 gestational weeks, indicated to undergo elective cesarean delivery for various indications
Key exclusion criteria (1 listed)
- extreme of age (below 18 or above 40 year), uncooperative patients, women under spinal anesthesia, previous abdominal scars, including previous cesarean or myomectomy, multiple gestation, BMI >35 kg/m², chorioamnionitis, hypersensitivity or contraindications to lidocaine, bronchial asthma, bleeding diathesis, pregnancy induced-hypertension, liver or kidney diseases, diabetes mellitus, and patients with psychological disturbance, or any form of chronic pain before or during pregnancy.
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 |
|---|---|---|
| Intravenous normal salineAlso: IV SalineNormal saline in a volume equivalent to that used in intravenous lidocaine group | Drug | Intraperitoneal instillation group, Placebo control group |
| Intraperitoneal normal salineAlso: IP SalinePatients received 00 ml of saline intraperitoneally | Drug | Intravenous injection group, Placebo control group |
| Intraperitoneal LidocaineAlso: IP LidocainePatients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure. | Drug | Intraperitoneal instillation group |
| Intravenous LidocaineAlso: IV LidocainePatients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery. | Drug | Intravenous injection group |
Primary outcome
Postoperative pain scoring (number)
Time frame: First 24 hours postoperative
6 secondary outcomes
The need for rescue postoperative analgesia.
Time frame: First 24 hours postoperative
Total pethidine consumption in 24 hours (mg)
Time frame: First 24 hours postoperative
The time to bowel sounds, hours
Time frame: First 3 days postoperative
The time to start regular diet, days
Time frame: First 3 days postoperative
Duration of hospital stay , days
Time frame: First 3 days postoperative
Any reported side effects
Time frame: First 3 days postoperative
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 14 Mar 2016.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravenous normal saline, Intraperitoneal normal saline and Intraperitoneal Lidocaine in people with Postcesarean Pain Relief, run by Benha University.
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: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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 pain scoring (number) (time frame: First 24 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 14 Mar 2016.