Postoperative PainPhase 2NCT06433713
Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections
A Phase 2 study testing Lidocaine IV in people with Postoperative Pain and Postoperative Return of Bowel Function, run by Cairo University at 1 site in Egypt.
Trial summary
Postoperative discomfort is a frequently seen adverse event after to caesarean operation. Early mobilization and bonding of the mother and her infant are typically impacted by this phenomenon. Nevertheless, the current state of postoperative analgesia and recovery remains inadequate in clinical settings. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Return of Bowel Function
- What is being tested?
- Lidocaine IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Apr 2024
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age > 18 years.
- American society of anesthesiology (ASA) class II (Normal pregnancy, well controlled gestational HTN, controlled preeclampsia without severe features, diet-controlled gestational DM).
- Singleton term pregnancy.
- Elective caesarean section.
- Spinal anesthesia.
Who cannot join
- Atypical postoperative care e.g. following caesarean hysterectomy.
- Inflammatory bowel disease.
- Prolonged surgery >1.5 hours.
- Medical disorders e.g. liver or renal affection
- Previous bowel surgery.
- History' of allergic reaction to lidocaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections, a Double-blinded Randomized Control Study
Postoperative discomfort is a frequently seen adverse event after to caesarean operation. Early mobilization and bonding of the mother and her infant are typically impacted by this phenomenon.
Nevertheless, the current state of postoperative analgesia and recovery remains inadequate in clinical settings. In the context of major abdominal surgery, opioids are often regarded as the preferred postoperative analgesic. Nevertheless, they possess adverse side effects that might impact the process of recuperation after surgery. These symptoms include nausea and vomiting, decreased bowel movement, and shallow breathing.
Read more
One additional challenging consequence after surgery is the delayed restoration of bowel function, which has the potential to extend the duration of hospitalization and impede the initiation of oral feeding, resulting in gaseous colonic distension.
The administration of lidocaine infusion has been shown to possess analgesic, anti-hyperalgesic, and anti-inflammatory characteristics.
The use of intravenous lidocaine after surgery is postulated to have the dual effect of mitigating postoperative pain and expediting the resumption of bowel movements.
Recent studies have shown that the administration of intravenous lidocaine, either as a single dosage or by continuous infusion, may have potential advantages in maintaining gastrointestinal motility and exerting an impact on biochemical pain mechanisms.
However, the literature presents contradictory data about the effectiveness of lidocaine in providing sufficient postoperative pain relief and reducing postoperative ileus.
Consequently, this study was conducted and aimed to assess the effect of intravenous intraoperative lidocaine on postoperative pain and early return of bowel function following elective caesarean section.
This randomized clinical trial was conducted at Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University Hospitals from August till December 2023. A total of 60 pregnant women underwent elective caesarean section were enrolled and randomized into two groups; experimental group who received IV infusion of lidocaine starting with skin incision, which was maintained until skin closure and control group who received 0.9% normal saline at the same rate as that described in the experimental group. Both groups were compared as regard total operative time, medications given, start-stop time of the study drug infusion, and degree of pain using visual analogue scale, need for analgesics, time for first healing of normal intestinal sounds and time to first flatus and symptoms of lidocaine toxicity were recorded.
- Being tested
- Lidocaine IV, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IVDrug
They received IV infusion of 2 mg/kg per hour of lidocaine starting with skin incision, which was maintained until skin closure. This was done using a syringe pump with the calculated amount of lidocaine added to 50 ml of normal saline infused at a rate of 50 ml/hr.
PlaceboDrug
Also called Normal saline
0.9% normal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | Intravenous lidocaine infusion, 2 mg/kg/hour Receives: Drug: Lidocaine IV |
| Control Group | Placebo comparator | Normal saline infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of intraoperative intravenous lidocaine on visual analogue scale pain scores among the two groups.
The patients are asked to describe how much pain they feel in a scale from 0 to 10. Minimum score 0, maximum score 10 where 10 is worse and means more pain
Measured: 12-24 hours
Effect of intraoperative intravenous lidocaine on early return of bowel function assessed by the time to first hearing of bowel sounds and the time to first flatus passing.
Time to hearing of bowel sounds, passing of flatus \& passing of stool
Measured: 12-24 hours
Secondary outcomes (2)
Occurrence of lidocaine toxicity with the standard dose given.
Nausea, perioral numbness, neurological symptoms or cardiac arrhythmia
Measured: 12-24 hours
Duration of hospital stay.
Measured: 12-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Dec 2023
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Fathy Zaky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433713
- Sponsor's protocol ID
- MS-220
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections, a Double-blinded Randomized Control Study
- ClinicalTrials.gov ID
- NCT06433713
- Acronym / sponsor ID
- MS-220
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 30 May 2024 (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.
Postoperative discomfort is a frequently seen adverse event after to caesarean operation. Early mobilization and bonding of the mother and her infant are typically impacted by this phenomenon.
Nevertheless, the current state of postoperative analgesia and recovery remains inadequate in clinical settings. In the context of major abdominal surgery, opioids are often regarded as the preferred postoperative analgesic. Nevertheless, they possess adverse side effects that might impact the process of recuperation after surgery. These symptoms include nausea and vomiting, decreased bowel movement, and shallow breathing.
One additional challenging consequence after surgery is the delayed restoration of bowel function, which has the potential to extend the duration of hospitalization and impede the initiation of oral feeding, resulting in gaseous colonic distension.
The administration of lidocaine infusion has been shown to possess analgesic, anti-hyperalgesic, and anti-inflammatory characteristics.
The use of intravenous lidocaine after surgery is postulated to have the dual effect of mitigating postoperative pain and expediting the resumption of bowel movements.
Recent studies have shown that the administration of intravenous lidocaine, either as a single dosage or by continuous infusion, may have potential advantages in maintaining gastrointestinal motility and exerting an impact on biochemical pain mechanisms.
However, the literature presents contradictory data about the effectiveness of lidocaine in providing sufficient postoperative pain relief and reducing postoperative ileus.
Consequently, this study was conducted and aimed to assess the effect of intravenous intraoperative lidocaine on postoperative pain and early return of bowel function following elective caesarean section.
This randomized clinical trial was conducted at Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University Hospitals from August till December 2023. A total of 60 pregnant women underwent elective caesarean section were enrolled and randomized into two groups; experimental group who received IV infusion of lidocaine starting with skin incision, which was maintained until skin closure and control group who received 0.9% normal saline at the same rate as that described in the experimental group. Both groups were compared as regard total operative time, medications given, start-stop time of the study drug infusion, and degree of pain using visual analogue scale, need for analgesics, time for first healing of normal intestinal sounds and time to first flatus and symptoms of lidocaine toxicity were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: Lidocaine IVIntravenous lidocaine infusion, 2 mg/kg/hour |
| Control Group | Placebo comparator | Drug: PlaceboNormal saline infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age > 18 years.
- American society of anesthesiology (ASA) class II (Normal pregnancy, well controlled gestational HTN, controlled preeclampsia without severe features, diet-controlled gestational DM).
- Singleton term pregnancy.
- Elective caesarean section.
- Spinal anesthesia.
Key exclusion criteria (6 listed)
- Atypical postoperative care e.g. following caesarean hysterectomy.
- Inflammatory bowel disease.
- Prolonged surgery >1.5 hours.
- Medical disorders e.g. liver or renal affection
- Previous bowel surgery.
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 |
|---|---|---|
| Lidocaine IVThey received IV infusion of 2 mg/kg per hour of lidocaine starting with skin incision, which was maintained until skin closure. This was done using a syringe pump with the calculated amount of lidocaine added to 50 ml of normal saline infused at a rate of 50 ml/hr. | Drug | Lidocaine Group |
| PlaceboAlso: Normal saline0.9% normal saline infusion | Drug | Control Group |
Primary outcome
Effect of intraoperative intravenous lidocaine on visual analogue scale pain scores among the two groups.
Time frame: 12-24 hours
The patients are asked to describe how much pain they feel in a scale from 0 to 10. Minimum score 0, maximum score 10 where 10 is worse and means more pain
Effect of intraoperative intravenous lidocaine on early return of bowel function assessed by the time to first hearing of bowel sounds and the time to first flatus passing.
Time frame: 12-24 hours
Time to hearing of bowel sounds, passing of flatus \& passing of stool
2 secondary outcomes
Occurrence of lidocaine toxicity with the standard dose given.
Time frame: 12-24 hours
Duration of hospital stay.
Time frame: 12-24 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 30 May 2024.
- Individual participant dataSharing planned: Undecided
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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 Phase 2 study testing Lidocaine IV in people with Postoperative Pain and Postoperative Return of Bowel Function, run by Cairo 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 5 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: finished, as of the sponsor's last update on 30 May 2024. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Effect of intraoperative intravenous lidocaine on visual analogue scale pain scores among the two groups. (time frame: 12-24 hours). The study lists 2 primary outcomes in all. 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 30 May 2024.