Laparoscopic AppendectomyNCT03004222
A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine
A study testing Bupivacaine in people with Laparoscopic Appendectomy, run by Metro Health, Michigan at 1 site in United States.
Trial summary
The purpose of this research is to determine if spraying a local anesthetic to the cecum after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed after surgery and reduces the time to discharge from the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Appendectomy
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age and older
- Laparoscopic appendectomy at Metro Health Hospital
Who cannot join
- Adults unable to consent Non-English speaking patients
- Suspected or known malignant disease
- Patients with known allergies to the local anesthetic
- Utilizes opioid pain medicine for a chronic condition
- Elective laparoscopic appendectomy
- Known allergy or contraindication to ketorolac
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double Blinded Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine: Does it Reduce Post-operative Opioid Use Following Laparoscopic Appendectomy?
The purpose of this research is to determine if spraying a local anesthetic to the cecum after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed after surgery and reduces the time to discharge from the hospital.
Read the detailed description
The purpose of this study is to determine the effectiveness of using intraperitoneal anesthetic during appendectomy. Subjects will be randomized to receive either 20 mL 0.5% bupivicaine or 20 mL of normal saline (placebo) instilled in the right lower quadrant at the cecum after appendix has been removed. Narcotic consumption will be tracked postoperatively. Hypothesis is that instilling local anesthetic at the cecum during a laparoscopic appendectomy will decrease the amount of narcotic a patient uses postoperatively. Secondarily, this study will attempt to determine if there is a decrease in length of stay for the subjects randomized to the anesthetic infiltration.
- Conditions
- Laparoscopic Appendectomy
- Being tested
- Bupivacaine, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
20 ml of 0.5% Bupivacaine
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Local anesthetic (Bupivicaine) | Experimental | The experimental arm intervention is 75 subjects will receive the study agent (20 mL of 0.5% bupivacaine) to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred Receives: Drug: Bupivacaine |
| Placebo 20 ml | Placebo comparator | 75 subjects will be treated with normal saline/placebo to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total narcotic use following surgery until the time of discharge from the hospital.
Measured: 1, 2, 4 hours
Secondary outcomes (2)
Time to Discharge
Measured: 12 hours
Pain Level Scores at 1, 2, 4, and 12 hours postoperatively
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startJul 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic AppendectomyStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metro Health, Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karlin Sevensma, DO, Principal investigator, Metro Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004222
- Sponsor's protocol ID
- Appendectomy Study
- Status last verified
- Jan 2018
- First submitted
- 21 Dec 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blinded Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine: Does it Reduce Post-operative Opioid Use Following Laparoscopic Appendectomy?
- ClinicalTrials.gov ID
- NCT03004222
- Acronym / sponsor ID
- Appendectomy Study
- Conditions
- Laparoscopic Appendectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Metro Health, MichiganUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 28 Dec 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.
The purpose of this research is to determine if spraying a local anesthetic to the cecum after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed after surgery and reduces the time to discharge from the hospital.
Detailed description
The purpose of this study is to determine the effectiveness of using intraperitoneal anesthetic during appendectomy. Subjects will be randomized to receive either 20 mL 0.5% bupivicaine or 20 mL of normal saline (placebo) instilled in the right lower quadrant at the cecum after appendix has been removed. Narcotic consumption will be tracked postoperatively. Hypothesis is that instilling local anesthetic at the cecum during a laparoscopic appendectomy will decrease the amount of narcotic a patient uses postoperatively. Secondarily, this study will attempt to determine if there is a decrease in length of stay for the subjects randomized to the anesthetic infiltration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthetic (Bupivicaine) | Experimental | Drug: BupivacaineThe experimental arm intervention is 75 subjects will receive the study agent (20 mL of 0.5% bupivacaine) to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred |
| Placebo 20 ml | Placebo comparator | Drug: Placebos75 subjects will be treated with normal saline/placebo to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age and older
- Laparoscopic appendectomy at Metro Health Hospital
Key exclusion criteria (6 listed)
- Adults unable to consent Non-English speaking patients
- Suspected or known malignant disease
- Patients with known allergies to the local anesthetic
- Utilizes opioid pain medicine for a chronic condition
- Elective laparoscopic appendectomy
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 |
|---|---|---|
| Bupivacaine20 ml of 0.5% Bupivacaine | Drug | Local anesthetic (Bupivicaine) |
| Placebos | Drug | Placebo 20 ml |
Primary outcome
Total narcotic use following surgery until the time of discharge from the hospital.
Time frame: 1, 2, 4 hours
2 secondary outcomes
Time to Discharge
Time frame: 12 hours
Pain Level Scores at 1, 2, 4, and 12 hours postoperatively
Time frame: 12 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 18 Jan 2018.
- Individual participant dataSharing planned: No
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Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
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Retrospective Acute Care Appendectomy Study
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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.
Karlin Sevensma, DO principal investigator
Metro Health Hospital
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 Laparoscopic Appendectomy, run by Metro Health, Michigan at 1 site in United States.
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 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 18 Jan 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 United States. 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?
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?
Total narcotic use following surgery until the time of discharge from the hospital. (time frame: 1, 2, 4 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 18 Jan 2018.