Postoperative ComplicationsNCT02976571
Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief
A study testing Bupivacaine in people with Postoperative Complications, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to Dec 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective laparoscopy
Who cannot join
- Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to pelvic pain Pregnancy Operations lasts more than 3 hours
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson medical center
Holon
Ohad Gluck, MD, 97235028329, ohadgluck@gmail.com
About this study
A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.
Read the detailed description
4 randomly assigned groups. Grop 1 will get sub cutaneous and intraperitoneal marcain. Grop 2 will get sub cutaneous marcaine and intraperitoneal saline. Grop 3 will get sub cutaneus saline and intraperitoneal marcaine. Grop 4 will get ub cutaneous and intraperitoneal saline
- Conditions
- Postoperative Complications
- Being tested
- Bupivacaine
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
Sub cutaneous and/or Intraperitoneal Marcaine application
| Study group | Role | What they receive |
|---|---|---|
| Sub cutaneous+Intraperitoneal | Experimental | Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine Receives: Drug: Bupivacaine |
| Sub cutaneous+Placebo | Active comparator | Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9% Receives: Drug: Bupivacaine |
| Placebo+Intraperitoneal | Active comparator | Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine Receives: Drug: Bupivacaine |
| Placebo+Placebo | Placebo comparator | Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9% Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level during movement, 8 hours after laparoscopy
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Supportive care
- 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
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ohad Gluck, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976571
- Sponsor's protocol ID
- 0198-16-WOMC
- Status last verified
- May 2018
- First submitted
- 23 Nov 2016
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gluck O, Barber E, Feldstein O, Tal O, Kerner R, Keidar R, Wolfson I, Ginath S, Bar J, Sagiv R. The effect of subcutaneous and intraperitoneal anesthesia on post laparoscopic pain: a randomized controlled trial. Sci Rep. 2021 Jan 8;11(1):81. doi: 10.1038/s41598-020-80130-6.
PubMed 33420214
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief
- ClinicalTrials.gov ID
- NCT02976571
- Acronym / sponsor ID
- 0198-16-WOMC
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Nov 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.
A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.
Detailed description
4 randomly assigned groups. Grop 1 will get sub cutaneous and intraperitoneal marcain. Grop 2 will get sub cutaneous marcaine and intraperitoneal saline. Grop 3 will get sub cutaneus saline and intraperitoneal marcaine. Grop 4 will get ub cutaneous and intraperitoneal saline
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sub cutaneous+Intraperitoneal | Experimental | Drug: BupivacaineSub cutaneous Bupivacaine+ Intraperitoneal bupivacaine |
| Sub cutaneous+Placebo | Active comparator | Drug: BupivacaineSub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9% |
| Placebo+Intraperitoneal | Active comparator | Drug: BupivacaineSub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine |
| Placebo+Placebo | Placebo comparator | Drug: BupivacaineSub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective laparoscopy
Key exclusion criteria (1 listed)
- Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to pelvic pain Pregnancy Operations lasts more than 3 hours
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 |
|---|---|---|
| BupivacaineAlso: MarcaineSub cutaneous and/or Intraperitoneal Marcaine application | Drug | Placebo+Intraperitoneal, Placebo+Placebo, Sub cutaneous+Intraperitoneal, Sub cutaneous+Placebo |
Primary outcome
Pain level during movement, 8 hours after laparoscopy
Time frame: 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 33420214Gluck O, Barber E, Feldstein O, Tal O, Kerner R, Keidar R, Wolfson I, Ginath S, Bar J, Sagiv R. The effect of subcutaneous and intraperitoneal anesthesia on post laparoscopic pain: a randomized controlled trial. Sci Rep. 2021 Jan 8;11(1):81. doi: 10.1038/s41598-020-80130-6.
- 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.
Ohad Gluck, MD principal investigator
Wolfson 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 Bupivacaine in people with Postoperative Complications, run by Wolfson Medical Center 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 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: status not confirmed, as of the sponsor's last update on 9 May 2018. 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 Ohad Gluck, MD (97235028329, ohadgluck@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level during movement, 8 hours after laparoscopy (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976571, which also lists 1 linked publication.
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 9 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.