Post Operative Pain (Post Laparoscopic Hernia Repair)Phase 4NCT02055053
Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
A Phase 4 study testing 0.5% Bupivicaine in people with Post Operative Pain (Post Laparoscopic Hernia Repair), run by Lahey Clinic at 1 site in United States.
Trial summary
To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain (Post Laparoscopic Hernia Repair)
- What is being tested?
- 0.5% Bupivicaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 16 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair
- American Society of Anesthesiology (ASA) Class I and II
Who cannot join
- Conversion from laparoscopic to open surgery
- History of Chronic pain or ongoing treatment for chronic pain
- Age less than 18 yrs
- Allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled Trial of the Effects of Infusing Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.
- Being tested
- 0.5% Bupivicaine
- Keywords
- Post Operative Pain, hernia repair
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% BupivicaineDrug
Also called Marcaine, Sensorcaine
Local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| anesthetic intervention | Experimental | After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. Receives: Drug: 0.5% Bupivicaine |
| Saline intervention | Placebo comparator | After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. Receives: Drug: 0.5% Bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Pain Score Assessment (VAS)
Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain)
Measured: Post-operative period
Visual Analog Scale Pain Score Assessment (VAS)
Pain level recorded at 3 days after surgery. VAS scale measures pain in increments of whole numbers from 0 (no pain) to 10 (most sever pain imaginable)
Measured: Pain scale 3 days after surgery
Secondary outcomes (2)
Amount of Pain Medication Used in Oral Morphine Equivalents
Total mg of opiate after surgery
Measured: 4 hours after surgery
Duration of Narcotic Used to Control Pain
Number of days post-operatively narcotic is used
Measured: 4 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startAug 2013
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain (Post Laparoscopic Hernia Repair)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Nepomnayshy, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055053
- Sponsor's protocol ID
- LCID 2013-031
- Status last verified
- Dec 2021
- First submitted
- 3 Feb 2014
- Last updated
- 11 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rade M, Jayaram A, Birkett R, Ford H, Birkett D, Nepomnayshy D. A randomized, double-blinded, placebo-controlled trial of the effects of infusing local analgesia on post-operative pain during laparoscopic inguinal hernia repair. Surg Endosc. 2023 Mar;37(3):1970-1975. doi: 10.1007/s00464-022-09697-7. Epub 2022 Oct 20.
PubMed 36266481
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled Trial of the Effects of Infusing Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT02055053
- Acronym / sponsor ID
- LCID 2013-031
- Keywords
- Post Operative Pain, hernia repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Posted 14 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anesthetic intervention | Experimental | Drug: 0.5% BupivicaineAfter deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. |
| Saline intervention | Placebo comparator | Drug: 0.5% BupivicaineAfter deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair
- American Society of Anesthesiology (ASA) Class I and II
Key exclusion criteria (4 listed)
- Conversion from laparoscopic to open surgery
- History of Chronic pain or ongoing treatment for chronic pain
- Age less than 18 yrs
- Allergy to local anesthetics
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 |
|---|---|---|
| 0.5% BupivicaineAlso: Marcaine, SensorcaineLocal anesthetic | Drug | Saline intervention, anesthetic intervention |
Primary outcome
Visual Analog Scale Pain Score Assessment (VAS)
Time frame: Post-operative period
Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain)
Visual Analog Scale Pain Score Assessment (VAS)
Time frame: Pain scale 3 days after surgery
Pain level recorded at 3 days after surgery. VAS scale measures pain in increments of whole numbers from 0 (no pain) to 10 (most sever pain imaginable)
2 secondary outcomes
Amount of Pain Medication Used in Oral Morphine Equivalents
Time frame: 4 hours after surgery
Duration of Narcotic Used to Control Pain
Time frame: 4 weeks post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36266481Rade M, Jayaram A, Birkett R, Ford H, Birkett D, Nepomnayshy D. A randomized, double-blinded, placebo-controlled trial of the effects of infusing local analgesia on post-operative pain during laparoscopic inguinal hernia repair. Surg Endosc. 2023 Mar;37(3):1970-1975. doi: 10.1007/s00464-022-09697-7. Epub 2022 Oct 20.
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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 4 study testing 0.5% Bupivicaine in people with Post Operative Pain (Post Laparoscopic Hernia Repair), run by Lahey Clinic 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 4 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 11 Jan 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scale Pain Score Assessment (VAS) (time frame: Post-operative period). 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?
On the ClinicalTrials.gov record for NCT02055053, 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 11 Jan 2022.