PainNCT02826876
The Efficacy of Surgical Site Treatment With Ropivacaine in Laparoscopic Surgery
A study testing Topical use, laparoscopic repair of inguinal hernia and laparoscopic bariatric surgery in people with Pain, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use of narcotic drugs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Topical use, laparoscopic repair of inguinal hernia and laparoscopic bariatric surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to Jul 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic bariatric surgery
- Laparoscopic inguinal hernia surgery
Who cannot join
- Cardiac arrythmias
- Active ischemic heart disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Analgesia in Laparoscopic Surgery
Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use of narcotic drugs.
Read the detailed description
At the end of laparoscopic surgery the investigators will spray ropivacaine in the surgical site; and later the investigators will monitor pain intensity and use of analgesic drugs
- Conditions
- Pain
- Being tested
- Topical use, laparoscopic repair of inguinal hernia, laparoscopic bariatric surgery
- Keywords
- Laparoscopic surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical useDrug
Also called Ropivacaine, Placebo
Topical use of Ropivacaine in laparoscopic surgery
laparoscopic repair of inguinal herniaOther
intra-operative treatment with ropivacaine Vs placebo in laparoscopic repair of inguinal hernia
laparoscopic bariatric surgeryOther
intra-operative treatment with ropivacaine Vs placebo in laparoscopic bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Placebo comparator | Topical use of Ropivacaine Receives: Drug: Topical use; Other: laparoscopic repair of inguinal hernia; Other: laparoscopic bariatric surgery |
| Placebo | Placebo comparator | Topical use of placebo Receives: Drug: Topical use; Other: laparoscopic repair of inguinal hernia; Other: laparoscopic bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale as measured by pain scale questionnaire
post operative pain intensity will be assisted by VAS(visual analog pain scale) scale at fixed times after surgery
Measured: 1 Week
Secondary outcomes (1)
Reducing use of narcotics according to nurse records
patients will be treated by standard analgetic protocol, the records of analgetic drugs will be collected during patients hospitalization
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Farraj Moaad, Western Galilee Hospital-Nahariya
- Investigators
- Moaad H Farraj, Dr, Principal investigator, Galilee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826876
- Sponsor's protocol ID
- 0196-15-NHR
- Status last verified
- Jul 2016
- First submitted
- 22 Jun 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Analgesia in Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02826876
- Acronym / sponsor ID
- 0196-15-NHR
- Conditions
- Pain
- Keywords
- Laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 11 Jul 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.
Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use of narcotic drugs.
Detailed description
At the end of laparoscopic surgery the investigators will spray ropivacaine in the surgical site; and later the investigators will monitor pain intensity and use of analgesic drugs
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 |
|---|---|---|
| Ropivacaine | Placebo comparator | Drug: Topical use, Other: laparoscopic repair of inguinal hernia, Other: laparoscopic bariatric surgeryTopical use of Ropivacaine |
| Placebo | Placebo comparator | Drug: Topical use, Other: laparoscopic repair of inguinal hernia, Other: laparoscopic bariatric surgeryTopical use of placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Laparoscopic bariatric surgery
- Laparoscopic inguinal hernia surgery
Key exclusion criteria (3 listed)
- Cardiac arrythmias
- Active ischemic heart disease
- 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 |
|---|---|---|
| Topical useAlso: Ropivacaine, PlaceboTopical use of Ropivacaine in laparoscopic surgery | Drug | Placebo, Ropivacaine |
| laparoscopic repair of inguinal herniaintra-operative treatment with ropivacaine Vs placebo in laparoscopic repair of inguinal hernia | Other | Placebo, Ropivacaine |
| laparoscopic bariatric surgeryintra-operative treatment with ropivacaine Vs placebo in laparoscopic bariatric surgery | Other | Placebo, Ropivacaine |
Primary outcome
Pain scale as measured by pain scale questionnaire
Time frame: 1 Week
post operative pain intensity will be assisted by VAS(visual analog pain scale) scale at fixed times after surgery
1 secondary outcome
Reducing use of narcotics according to nurse records
Time frame: 1 Week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
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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.
Moaad H Farraj, Dr principal investigator
Galilee 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 Topical use, laparoscopic repair of inguinal hernia and laparoscopic bariatric surgery in people with Pain, run by Western Galilee Hospital-Nahariya 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 2 inclusion and 3 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 11 Jul 2016. 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 Moaad H Farraj, Dr (0507887996 ext. 972, moaad.farraj@naharia.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale as measured by pain scale questionnaire (time frame: 1 Week). 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 11 Jul 2016.