InfertilityNCT04506034
Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy
A study testing lidocaine patches, IV lidocaine and IV saline infusion in people with Infertility, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
To evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic surgery in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- lidocaine patches, IV lidocaine and IV saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Sep 2021
- 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
- female undergoing elective gynecologic surgery
Who cannot join
- known allergy to lidocaine,
- respiratory or cardiac dysfunction, arrhythmia, treatment with antiarrhythmic drugs,
- inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- hepatic, renal
- chronic use of analgesics or corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Laparoscopic Gynecologic Surgery? A Randomized Clinical Trial
To evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic surgery in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo.
Read the detailed description
Postoperative pain after gynecologic surgery is a challenging problem associated with increased morbidity and cost. The inflammatory response to surgery plays a crucial rule in inducing postoperative illus. Systemic local anesthetics proved to have anti-inflammatory properties that may be beneficial in preventing ileus added to its analgesic actions. The lidocaine patch evaluated in many types of pain with promising results. The study try to evaluate the patch in perioperative field as a more simple and safe technique than the intravenous route.
- Conditions
- Infertility
- Being tested
- lidocaine patches, IV lidocaine, IV saline infusion
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine patchesDrug
Also called lidocaine patch
for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.
IV lidocaineDrug
Also called lidocaine infusion
received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight >70 kg or 1 mg/min if body weight <70 kg.
IV saline infusionDrug
Also called placebo
received i.v. saline infusion.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine patches | Experimental | for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day. Receives: Drug: lidocaine patches |
| IV lidocaine | Active comparator | received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight >70 kg or 1 mg/min if body weight <70 kg. Receives: Drug: IV lidocaine |
| IV saline infusion | Placebo comparator | received i.v. saline infusion. Receives: Drug: IV saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS scores at rest and during coughing were recorded postoperatively
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
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 posted10 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- nahla w Shady, md, Study chair, Aswan universirty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506034
- Sponsor's protocol ID
- aswu/277/7/18
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Laparoscopic Gynecologic Surgery? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04506034
- Acronym / sponsor ID
- aswu/277/7/18
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 10 Aug 2020 (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.
To evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic surgery in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo.
Detailed description
Postoperative pain after gynecologic surgery is a challenging problem associated with increased morbidity and cost. The inflammatory response to surgery plays a crucial rule in inducing postoperative illus. Systemic local anesthetics proved to have anti-inflammatory properties that may be beneficial in preventing ileus added to its analgesic actions. The lidocaine patch evaluated in many types of pain with promising results. The study try to evaluate the patch in perioperative field as a more simple and safe technique than the intravenous route.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| lidocaine patches | Experimental | Drug: lidocaine patchesfor every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day. |
| IV lidocaine | Active comparator | Drug: IV lidocainereceived i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight >70 kg or 1 mg/min if body weight <70 kg. |
| IV saline infusion | Placebo comparator | Drug: IV saline infusionreceived i.v. saline infusion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female undergoing elective gynecologic surgery
Key exclusion criteria (5 listed)
- known allergy to lidocaine,
- respiratory or cardiac dysfunction, arrhythmia, treatment with antiarrhythmic drugs,
- inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- hepatic, renal
- chronic use of analgesics or corticosteroids
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 patchesAlso: lidocaine patchfor every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day. | Drug | lidocaine patches |
| IV lidocaineAlso: lidocaine infusionreceived i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight >70 kg or 1 mg/min if body weight <70 kg. | Drug | IV lidocaine |
| IV saline infusionAlso: placeboreceived i.v. saline infusion. | Drug | IV saline infusion |
Primary outcome
Pain VAS scores at rest and during coughing were recorded postoperatively
Time frame: 24 hours
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Individual participant dataSharing planned: No
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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.
nahla w Shady, md study chair
Aswan universirty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine patches, IV lidocaine and IV saline infusion in people with Infertility, run by Aswan University 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 1 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: status not confirmed, as of the sponsor's last update on 10 Aug 2020. 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.
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 hany f Sallam, md (+20102435461 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS scores at rest and during coughing were recorded postoperatively (time frame: 24 hours). 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 10 Aug 2020.