Post-operative PainMarcaineNCT01861665
Marcaine Use in Laparoscopic Gynecological Surgery
A study testing Marcaine- 0.25% and Marcaine 0.25%. in people with Post-operative Pain, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Marcaine- 0.25% and Marcaine 0.25%.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jan 2017
- Phase
- Interventional
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Ages 18-50
- BMI 20-35
- Gynecologic ambulatory cases only
- Total of 3 incisions, with left and right incisions both being 5mm-10mm in size
- Not taking pain medications prior to surgery
- Length of surgery up to 3 hours
- PACU stay up to 6 hours
- Willing and able to sign informed consent
Who cannot join
- • Age or BMI out of range
- Surgery longer than 3 hours or PACU stay longer than 6 hours
- patients with chronic pelvic pain
- Oncologic cases
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: A Comparative Trial of Marcaine Administration in Laparoscopic Gynecologic Surgery Using Either a Pre- or Post-operative Injection.
The purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection.
Read the detailed description
Post-operative pain control is a key component of a patient's experience with surgery. In laparoscopic surgery, small (5 to 12mm) incisions are made, usually at the umbilicus and/on at either side of the lower abdomen, to allow insertion of a laparoscopic camera ("scope") and various laparoscopic instruments. The advantages for the patient of this approach compared to conventional open surgery include faster recovery with a significantly shorter hospital stay, less pain and less requirements for pain medication with a better cosmetic outcome. In many cases, the patient will go home within 24 hours of surgery. Many laparoscopic surgeons administer local anesthesia at the incision sites to assist in post-operative pain control. The best method for administration of the local anesthetic for optimal pain relief remains unclear. Some research has demonstrated that perhaps preemptive administration of local anesthetic improves post-operative pain control although in these studies, differences in patient populations and perception of pain between different patients makes comparison difficult. Optimizing analgesia protocols would benefit patients resulting in better pain relief and less use of narcotic analgesics with their associated side effects.
- Conditions
- Post-operative Pain
- Being tested
- Marcaine- 0.25%, Marcaine 0.25%.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcaine- 0.25%Drug
Marcaine 0.25% administered pre-incision.
Marcaine 0.25%.Drug
Marcaine 0.25% administered post-incision.
| Study group | Role | What they receive |
|---|---|---|
| Marcaine administered pre-incision. | Active comparator | Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision. Receives: Drug: Marcaine- 0.25% |
| Marcaine administered post-incision | Active comparator | Marcaine 0.25% administered post-incision, total amount 5cc per incision. Receives: Drug: Marcaine 0.25%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Faces Pain Rating Scale
Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain.
Measured: Post surgery day 0, post surgery day 1, post surgery day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startJun 2010
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Investigator no longer recruiting subjects.
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 PainStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Patients are acting as their own control receiving Bupivicaine (Marcaine) on both sides. One arm is pre incision the other arm is post incision.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Schattman, MD, Principal investigator, Weill Medical College of Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861665
- Sponsor's protocol ID
- 1004010977
- Acronym
- Marcaine
- Status last verified
- Oct 2018
- First submitted
- 21 May 2013
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Singer T, Huang JY, Schattman GL, Joseph M, Stubbs RE, Rosenwaks Z. RCT- Comparing Bupivicaine Adminstration in Laparoscopic Gynecologic Surgery Using Either a Pre-Incision or Post-Closure Injection. Journal of Minimally Invasive Gynecology 19 (6): S46, 2012.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Trial of Marcaine Administration in Laparoscopic Gynecologic Surgery Using Either a Pre- or Post-operative Injection.
- ClinicalTrials.gov ID
- NCT01861665
- Acronym / sponsor ID
- Marcaine / 1004010977
- Conditions
- Post-operative Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator no longer recruiting subjects.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Posted 26 Mar 2018
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 trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection.
Detailed description
Post-operative pain control is a key component of a patient's experience with surgery. In laparoscopic surgery, small (5 to 12mm) incisions are made, usually at the umbilicus and/on at either side of the lower abdomen, to allow insertion of a laparoscopic camera ("scope") and various laparoscopic instruments. The advantages for the patient of this approach compared to conventional open surgery include faster recovery with a significantly shorter hospital stay, less pain and less requirements for pain medication with a better cosmetic outcome. In many cases, the patient will go home within 24 hours of surgery. Many laparoscopic surgeons administer local anesthesia at the incision sites to assist in post-operative pain control. The best method for administration of the local anesthetic for optimal pain relief remains unclear. Some research has demonstrated that perhaps preemptive administration of local anesthetic improves post-operative pain control although in these studies, differences in patient populations and perception of pain between different patients makes comparison difficult. Optimizing analgesia protocols would benefit patients resulting in better pain relief and less use of narcotic analgesics with their associated side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients are acting as their own control receiving Bupivicaine (Marcaine) on both sides. One arm is pre incision the other arm is post incision.
| Arm | Type | Receives |
|---|---|---|
| Marcaine administered pre-incision. | Active comparator | Drug: Marcaine- 0.25%Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision. |
| Marcaine administered post-incision | Active comparator | Drug: Marcaine 0.25%.Marcaine 0.25% administered post-incision, total amount 5cc per incision. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Ages 18-50
Key exclusion criteria (5 listed)
- • Age or BMI out of range
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 |
|---|---|---|
| Marcaine- 0.25%Marcaine 0.25% administered pre-incision. | Drug | Marcaine administered pre-incision. |
| Marcaine 0.25%.Marcaine 0.25% administered post-incision. | Drug | Marcaine administered post-incision |
Primary outcome
Wong-Baker Faces Pain Rating Scale
Time frame: Post surgery day 0, post surgery day 1, post surgery day 2
Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationSinger T, Huang JY, Schattman GL, Joseph M, Stubbs RE, Rosenwaks Z. RCT- Comparing Bupivicaine Adminstration in Laparoscopic Gynecologic Surgery Using Either a Pre-Incision or Post-Closure Injection. Journal of Minimally Invasive Gynecology 19 (6): S46, 2012.
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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.
Glenn Schattman, MD principal investigator
Weill Medical College of Cornell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marcaine- 0.25% and Marcaine 0.25%. in people with Post-operative Pain, run by Weill Medical College of Cornell 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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Oct 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. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2018). 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?
Wong-Baker Faces Pain Rating Scale (time frame: Post surgery day 0, post surgery day 1, post surgery day 2). 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 NCT01861665, 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 12 Oct 2018.