Post Operative PainNCT01452633
Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy
A study testing 0.25% bupivicaine will be injected at the study port site prior to incision, Saline will be injected at the study port site prior to incision and Saline will be in injected into the port site prior to closure in people with Post Operative Pain, run by Stony Brook University at 1 site in United States.
Trial summary
This study will help to answer the question, "Does injecting local anesthetic before laparoscopic instrument ports are placed decrease pain after surgery?" Patients participating will be randomly assigned to receive local anesthetic or saline injection at the site of a laparoscopic instrument port as part of their… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- 0.25% bupivicaine will be injected at the study port site prior to incision, Saline will be injected at the study port site prior to incision and Saline will be in injected into the port site prior to closure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to May 2014
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing laparoscopic surgery
Who cannot join
- Cardiovascular instability
- malignancies
- pulmonary conditions incompatible with laparoscopic surgery
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
James N Droesch, MD, 631-444-2757, james.droesch@sbumed.org
Todd Griffin, MD, 6314442757, todd.griffin@sbumed.org
About this study
Official title: Effect of Preincisional Local Analgesia on Post-Operative Pain in 10-12mm Lateral Port Sites
This study will help to answer the question, "Does injecting local anesthetic before laparoscopic instrument ports are placed decrease pain after surgery?" Patients participating will be randomly assigned to receive local anesthetic or saline injection at the site of a laparoscopic instrument port as part of their planned surgery. After surgery at 4 and 24 hours the patient will be asked to rate their pain on a simple chart.
Read the detailed description
The literature is divided on the efficacy of preincisional local analgesia injections at laparoscopic port sites to decrease post operative pain. One reason for this lack of a clear conclusion is the fact that prior studies included small and large port sizes. Many small port sites have little pain associated with them so showing a reduction with medicine is statistically difficult. The investigators have noted that larger, lateral port sites which require fascial closure are the sites that patients consistently note pain at. Our protocol will include the use of 0.25% marcaine injections at all the surgical ports other than the large lateral port used for gynecologic laparoscopy. Patients would then be randomized and surgeons would be blinded as to which patients receive the marcaine or a saline injection at the large lateral port site. Visual analog pain scales will be assessed at 4 and 24 hours after surgery. An additional two arms have been added to include 50 patients randomized to 0.25% marcaine or saline injection just prior to incisional closure in the absence of any preincisional intervention.
- Conditions
- Post Operative Pain
- Being tested
- 0.25% bupivicaine will be injected at the study port site prior to incision, Saline will be injected at the study port site prior to incision, Saline will be in injected into the port site prior to closure, 0.25% bupivicaine will be injected into the port site prior to closure
- Keywords
- pain, laparoscopy, reduction
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% bupivicaine will be injected at the study port site prior to incisionDrug
Also called marcaine
Injection will precede the incision
Saline will be injected at the study port site prior to incisionDrug
Also called normal saline
Injection will precede incision
Saline will be in injected into the port site prior to closureDrug
Saline will be injected into the port site prior to the closure without any preincisional intervention
0.25% bupivicaine will be injected into the port site prior to closureDrug
Also called marcaine
0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention
| Study group | Role | What they receive |
|---|---|---|
| Preincision Placebo | Placebo comparator | This group of patients will receive saline injection at study port site before incision Receives: Drug: Saline will be injected at the study port site prior to incision |
| Preincision Marcaine | Active comparator | This group will receive marcaine injection at the study port site prior to incision Receives: Drug: 0.25% bupivicaine will be injected at the study port site prior to incision |
| Postincision Placebo | Placebo comparator | This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure Receives: Drug: 0.25% bupivicaine will be injected at the study port site prior to incision; Drug: Saline will be in injected into the port site prior to closure |
| Postincision marcaine | Active comparator | This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure Receives: Drug: 0.25% bupivicaine will be injected at the study port site prior to incision; Drug: 0.25% bupivicaine will be injected into the port site prior to closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in post-operative pain at large lateral port sites
visual analog scoring of post-operative pain in a control and a treatment group
Measured: 4 and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Droesch, Stony Brook University
- Investigators
- James N Droesch, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452633
- Sponsor's protocol ID
- 241577-1
- Status last verified
- Jun 2013
- First submitted
- 12 Oct 2011
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preincisional Local Analgesia on Post-Operative Pain in 10-12mm Lateral Port Sites
- ClinicalTrials.gov ID
- NCT01452633
- Acronym / sponsor ID
- 241577-1
- Conditions
- Post Operative Pain
- Keywords
- pain, laparoscopy, reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 17 Oct 2011 (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.
This study will help to answer the question, "Does injecting local anesthetic before laparoscopic instrument ports are placed decrease pain after surgery?" Patients participating will be randomly assigned to receive local anesthetic or saline injection at the site of a laparoscopic instrument port as part of their planned surgery. After surgery at 4 and 24 hours the patient will be asked to rate their pain on a simple chart.
Detailed description
The literature is divided on the efficacy of preincisional local analgesia injections at laparoscopic port sites to decrease post operative pain. One reason for this lack of a clear conclusion is the fact that prior studies included small and large port sizes. Many small port sites have little pain associated with them so showing a reduction with medicine is statistically difficult. The investigators have noted that larger, lateral port sites which require fascial closure are the sites that patients consistently note pain at. Our protocol will include the use of 0.25% marcaine injections at all the surgical ports other than the large lateral port used for gynecologic laparoscopy. Patients would then be randomized and surgeons would be blinded as to which patients receive the marcaine or a saline injection at the large lateral port site. Visual analog pain scales will be assessed at 4 and 24 hours after surgery. An additional two arms have been added to include 50 patients randomized to 0.25% marcaine or saline injection just prior to incisional closure in the absence of any preincisional intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preincision Placebo | Placebo comparator | Drug: Saline will be injected at the study port site prior to incisionThis group of patients will receive saline injection at study port site before incision |
| Preincision Marcaine | Active comparator | Drug: 0.25% bupivicaine will be injected at the study port site prior to incisionThis group will receive marcaine injection at the study port site prior to incision |
| Postincision Placebo | Placebo comparator | Drug: 0.25% bupivicaine will be injected at the study port site prior to incision, Drug: Saline will be in injected into the port site prior to closureThis group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure |
| Postincision marcaine | Active comparator | Drug: 0.25% bupivicaine will be injected at the study port site prior to incision, Drug: 0.25% bupivicaine will be injected into the port site prior to closureThis group will receive preincisional marcaine and then marcaine injection at study port site prior to closure |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing laparoscopic surgery
Key exclusion criteria (3 listed)
- Cardiovascular instability
- malignancies
- pulmonary conditions incompatible with laparoscopic surgery
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 |
|---|---|---|
| 0.25% bupivicaine will be injected at the study port site prior to incisionAlso: marcaineInjection will precede the incision | Drug | Postincision Placebo, Postincision marcaine, Preincision Marcaine |
| Saline will be injected at the study port site prior to incisionAlso: normal salineInjection will precede incision | Drug | Preincision Placebo |
| Saline will be in injected into the port site prior to closureSaline will be injected into the port site prior to the closure without any preincisional intervention | Drug | Postincision Placebo |
| 0.25% bupivicaine will be injected into the port site prior to closureAlso: marcaine0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention | Drug | Postincision marcaine |
Primary outcome
Reduction in post-operative pain at large lateral port sites
Time frame: 4 and 24 hours after surgery
visual analog scoring of post-operative pain in a control and a treatment group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
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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.
James N Droesch, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.25% bupivicaine will be injected at the study port site prior to incision, Saline will be injected at the study port site prior to incision and Saline will be in injected into the port site prior to closure in people with Post Operative Pain, run by Stony Brook University 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 1 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 10 Jun 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in post-operative pain at large lateral port sites (time frame: 4 and 24 hours after surgery). 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 Jun 2013.