PainNCT02230735
Bupivacaine Injections Into Uterosacral Ligaments During Robotic Assisted Total Hysterectomies
A study testing Bipivacaine 0.5% with epinephrine and Normal Saline in people with Pain, run by Souza, Amanda, M.D. at 1 site in United States.
Trial summary
Will patients that receive injections of Marcaine into the uterine nerve via the uterosacral ligaments experience less pain postoperatively, need less narcotic pain medication and return to activities of daily living sooner. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Bipivacaine 0.5% with epinephrine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing robotically assisted total hysterectomies with cystoscopy and with or without procedures involving the adnexa (salpingectomies and salpingo-oophorectomies)
Who cannot join
- Patients undergoing single incision procedures, those having supracervical hysterectomies and additional procedures involving their pelvic floor (including bladder neck suspension, anterior colophorraphy, posterior colophorraphy, perinealplasty) and sacracolpopexy
- Patients with allergies to bupivacaine and its derivatives
- Patients taking monoamine oxidase inhibitors or tricyclic antidepressants
- Patients with known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
- Patients with abnormal ECG's and prolonged QT syndrome
- Patients who are currently requiring narcotic pain medication or use narcotic pain medications regularly (more than twice weekly)
Trial locations and contacts
1 site in 1 country.
United States1 site
Botsford General Hospital
Farmington Hills, Michigan, 48336
About this study
Official title: Effectiveness of Bupivacaine With Epinephrine Injections Into the Uterosacral Ligaments for Post-operative Pain Control and the Use of Narcotic Pain Medication Following Robotic Assisted Total Hysterectomies
Will patients that receive injections of Marcaine into the uterine nerve via the uterosacral ligaments experience less pain postoperatively, need less narcotic pain medication and return to activities of daily living sooner.
Read the detailed description
Gynecologists use paracervical blocks in the office for decreasing pain during office based procedures. Paracervical blocks, in the office, work by injecting the cervix with local anesthetic, typically lidocaine, at the area of the uterosacral ligaments. The uterosacral ligaments contain the uterine nerve, which branches off of levels T12-L2. By injecting the uterine nerve with the local anesthetic patients are better able to tolerate the procedure and have decreased pain post procedure. In the office, paracervical blocks are performed vaginally with injections at the 3 o'clock and 9 o'clock position of the cervix. The use of paracervical blocks by Chudnoff et al reviewed the effectiveness of paracervical blocks in office based procedures, however no one has evaluated the effectiveness of injecting the uterosacral ligaments under direct visualization with the camera that is placed into the abdomen during a robotic assisted gynecologic procedure. We propose that by injecting the uterosacral ligaments and thus the uterine nerve during robotic assisted hysterectomies with Marcaine (Bupivacaine 0.5% with epinephrine 1:200,000) we can offer patients superior pain relief. The onset of action with Marcaine is rapid and anesthesia is long lasting. The duration of anesthesia is significantly longer with Marcaine than any other commonly used local anesthetic. It has also been noted that there is a period of analgesia that persists after the return of sensation, during which time the need for strong analgesics is reduced. By injecting Marcaine we hypothesize that patients will have decreased pain and need less narcotic pain medication. This will allow the patient to return to normal activities of daily living sooner.
This is a randomized controlled double blinded trial in which patients will be assigned to receive saline (control group) or bupivacaine 0.5% with epinephrine 1:200,000 (treatment group). The randomization will be performed through a computerized system in the pharmacy at the pharmacy of the hospital where the study is occurring. The randomization will occur once the patient has consented to the study. The treatment arm of the study will receive a total injection of 14ml of bupivacaine with 7ml directed into the right uterosacral ligament and 7ml into the left uterosacral ligament. The control arm of the study will receive a total injection of 14ml of normal saline with 7ml directed into the right uterosacral ligament and 7ml into the left uterosacral ligament. These injections will take place after the uterus and cervix have been surgically removed and the vaginal cuff has been surgically closed.
The maximum dose of bupivacaine with epinephrine is 225mg. The total amount of bupivacaine that we have chosen to inject is below the maximum allowable dosing and yet we believe will be an adequate amount for providing pain relief.
Eligible patients will be consented for the study while in the preoperative holding area. Once consented the patient will be given a medication diary form that they will take home. The form asks the patient to fill in the name of pain medication that they were prescribed and the dosage. They will also have an area for them to tally the number of pills they have taken since being discharged from the hospital. If they take anything for pain other than that prescribed by the physician who performed the surgery the patient will be taken out of the study. The Wong-baker faces pain rating scale is included on the form which they will be using to rate their pain during the telephone encounters.
The pharmacy will be notified once consent is obtained that the patient is participating in the study. After which, the injectable solution will be sent to the OR labeled "Study Drug." The surgical team and the patient will be blinded to which arm they are assigned to. With the use of a Bierman needle the solution will be injected into the uterine nerve as it courses with the uterosacral ligaments on each side at the level of the vaginal cuff. If the uterosacral ligaments cannot be easily identified, the patient will be excluded from the study.
Follow up will take place via telephone encounters.
- Conditions
- Pain
- Being tested
- Bipivacaine 0.5% with epinephrine, Normal Saline
- Keywords
- Robotic, Hysterectomy, Uterosacral, Bupivacaine, Robotic hysterectomy pain control
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipivacaine 0.5% with epinephrineDrug
Also called Marcaine With Epinephrine 1:200,000
Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament
Normal SalineDrug
Also called 0.7%NS
(placebo for bupivacaine)
| Study group | Role | What they receive |
|---|---|---|
| Bipivacaine 0.5% with epinephrine | Experimental | Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament Receives: Drug: Bipivacaine 0.5% with epinephrine |
| Normal Saline | Placebo comparator | Total of 14 ml of normal saline, 7ml into the right uterosacral ligament and 7ml into the left uterosacral ligament Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores using wong-baker faces pain rating scale
Follow up will take place via telephone encounters on post-operative day number one, unless the patient is admitted overnight following the surgery which in that case the telephone encounters will take place on postoperative day two. The patient will be asked to rate their average pain score for that day using the Wong-Baker faces pain rating scale which will occur at the time of the phone encounter.
Measured: Post-operative day 1 or post-operative day 2 if they stay overnight following their surgery
Secondary outcomes (7)
Type and amount of narcotic pain medication used to achieve pain relief
The type and amount of narcotic pain medication used to achieve pain relief which will be documented using the medication diary given to patients prior to discharge home from the hospital.
Measured: Post-operative day number one and five. Post-opertive day two and six if they stay overnight following their surgery
Pain compared to a prior laparoscopic or robotic surgery
Patient will be asked if they have ever had a laparoscopic or robotic surgery before and if they have how does their current pain with this surgery compare to their previous surgery. They will choose from the following answer choices: Worse, Better, No difference, Can not Recall.
Measured: Post-operative day one and five, post-operative day two and six if they stay overnight in the hospital following their surgery
Ability to drive
Patient will be asked if they have been able to drive since their surgery. If they have been able to drive we will ask how many days after surgery were they able to start driving.
Measured: Post-operative day five, Postopertive day six if they stay overnight in the hospital following their surgery
Ability to perform household duties
On postoperative day five patient will be asked if they have been able to perform household duties. If their answer is yes they will then be asked how man days after their surgery were they able to start performing household duties
Measured: Post-operative day five, Posoperative day six if they stay overnight in the hospital following their surgery
Ability to perform routine activities of daily living
Patient will be asked if they have begun performing activities of daily living (i.e grooming, hygiene care, preparing meals). If patient says yes we will follow up asking the patient how many days after their surgery were they able to perform routine activities of daily living.
Measured: Post-opertive day five, Postopertive day six if they stay overnight in the hospital following their surgery
Body Mass Index
Patient will be weighed upon admission to the hospital and asked what their height is at which time a BMI will be calculated.
Measured: Obtained at time of admission to hospital
Secondary pain scores using wong-baker faces pain rating scale
The second follow up will take place via telephone encounters on post-operative day number five, unless the patient is admitted overnight following the surgery which in that case the telephone encounters will take place on postoperative days six. The patient will be asked to rate their average pain score for that day using the Wong-Baker faces pain rating scale which will occur at the time of the phone encounter.
Measured: Post-operative day 5 or post-operative day 6 if they stay overnight following their surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Study was never started.
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Souza, Amanda, M.D.
- Responsible party
- Sponsor
- Investigators
- Amanda M Souza, DO, Principal investigator, Souza, Amanda, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230735
- Sponsor's protocol ID
- SouzaA
- Status last verified
- May 2016
- First submitted
- 12 Aug 2014
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.
PubMed 20027030
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bupivacaine With Epinephrine Injections Into the Uterosacral Ligaments for Post-operative Pain Control and the Use of Narcotic Pain Medication Following Robotic Assisted Total Hysterectomies
- ClinicalTrials.gov ID
- NCT02230735
- Acronym / sponsor ID
- SouzaA
- Conditions
- Pain
- Keywords
- Robotic, Hysterectomy, Uterosacral, Bupivacaine, Robotic hysterectomy pain control
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Souza, Amanda, M.D.
- Study start
- Aug 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Sep 2014 (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.
Will patients that receive injections of Marcaine into the uterine nerve via the uterosacral ligaments experience less pain postoperatively, need less narcotic pain medication and return to activities of daily living sooner.
Detailed description
Gynecologists use paracervical blocks in the office for decreasing pain during office based procedures. Paracervical blocks, in the office, work by injecting the cervix with local anesthetic, typically lidocaine, at the area of the uterosacral ligaments. The uterosacral ligaments contain the uterine nerve, which branches off of levels T12-L2. By injecting the uterine nerve with the local anesthetic patients are better able to tolerate the procedure and have decreased pain post procedure. In the office, paracervical blocks are performed vaginally with injections at the 3 o'clock and 9 o'clock position of the cervix. The use of paracervical blocks by Chudnoff et al reviewed the effectiveness of paracervical blocks in office based procedures, however no one has evaluated the effectiveness of injecting the uterosacral ligaments under direct visualization with the camera that is placed into the abdomen during a robotic assisted gynecologic procedure. We propose that by injecting the uterosacral ligaments and thus the uterine nerve during robotic assisted hysterectomies with Marcaine (Bupivacaine 0.5% with epinephrine 1:200,000) we can offer patients superior pain relief. The onset of action with Marcaine is rapid and anesthesia is long lasting. The duration of anesthesia is significantly longer with Marcaine than any other commonly used local anesthetic. It has also been noted that there is a period of analgesia that persists after the return of sensation, during which time the need for strong analgesics is reduced. By injecting Marcaine we hypothesize that patients will have decreased pain and need less narcotic pain medication. This will allow the patient to return to normal activities of daily living sooner.
This is a randomized controlled double blinded trial in which patients will be assigned to receive saline (control group) or bupivacaine 0.5% with epinephrine 1:200,000 (treatment group). The randomization will be performed through a computerized system in the pharmacy at the pharmacy of the hospital where the study is occurring. The randomization will occur once the patient has consented to the study. The treatment arm of the study will receive a total injection of 14ml of bupivacaine with 7ml directed into the right uterosacral ligament and 7ml into the left uterosacral ligament. The control arm of the study will receive a total injection of 14ml of normal saline with 7ml directed into the right uterosacral ligament and 7ml into the left uterosacral ligament. These injections will take place after the uterus and cervix have been surgically removed and the vaginal cuff has been surgically closed.
The maximum dose of bupivacaine with epinephrine is 225mg. The total amount of bupivacaine that we have chosen to inject is below the maximum allowable dosing and yet we believe will be an adequate amount for providing pain relief.
Eligible patients will be consented for the study while in the preoperative holding area. Once consented the patient will be given a medication diary form that they will take home. The form asks the patient to fill in the name of pain medication that they were prescribed and the dosage. They will also have an area for them to tally the number of pills they have taken since being discharged from the hospital. If they take anything for pain other than that prescribed by the physician who performed the surgery the patient will be taken out of the study. The Wong-baker faces pain rating scale is included on the form which they will be using to rate their pain during the telephone encounters.
The pharmacy will be notified once consent is obtained that the patient is participating in the study. After which, the injectable solution will be sent to the OR labeled "Study Drug." The surgical team and the patient will be blinded to which arm they are assigned to. With the use of a Bierman needle the solution will be injected into the uterine nerve as it courses with the uterosacral ligaments on each side at the level of the vaginal cuff. If the uterosacral ligaments cannot be easily identified, the patient will be excluded from the study.
Follow up will take place via telephone encounters.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipivacaine 0.5% with epinephrine | Experimental | Drug: Bipivacaine 0.5% with epinephrineTotal of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament |
| Normal Saline | Placebo comparator | Drug: Normal SalineTotal of 14 ml of normal saline, 7ml into the right uterosacral ligament and 7ml into the left uterosacral ligament |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing robotically assisted total hysterectomies with cystoscopy and with or without procedures involving the adnexa (salpingectomies and salpingo-oophorectomies)
Key exclusion criteria (6 listed)
- Patients undergoing single incision procedures, those having supracervical hysterectomies and additional procedures involving their pelvic floor (including bladder neck suspension, anterior colophorraphy, posterior colophorraphy, perinealplasty) and sacracolpopexy
- Patients with allergies to bupivacaine and its derivatives
- Patients taking monoamine oxidase inhibitors or tricyclic antidepressants
- Patients with known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
- Patients with abnormal ECG's and prolonged QT syndrome
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 |
|---|---|---|
| Bipivacaine 0.5% with epinephrineAlso: Marcaine With Epinephrine 1:200,000Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament | Drug | Bipivacaine 0.5% with epinephrine |
| Normal SalineAlso: 0.7%NS(placebo for bupivacaine) | Drug | Normal Saline |
Primary outcome
Pain scores using wong-baker faces pain rating scale
Time frame: Post-operative day 1 or post-operative day 2 if they stay overnight following their surgery
Follow up will take place via telephone encounters on post-operative day number one, unless the patient is admitted overnight following the surgery which in that case the telephone encounters will take place on postoperative day two. The patient will be asked to rate their average pain score for that day using the Wong-Baker faces pain rating scale which will occur at the time of the phone encounter.
7 secondary outcomes
Type and amount of narcotic pain medication used to achieve pain relief
Time frame: Post-operative day number one and five. Post-opertive day two and six if they stay overnight following their surgery
Pain compared to a prior laparoscopic or robotic surgery
Time frame: Post-operative day one and five, post-operative day two and six if they stay overnight in the hospital following their surgery
Ability to drive
Time frame: Post-operative day five, Postopertive day six if they stay overnight in the hospital following their surgery
Ability to perform household duties
Time frame: Post-operative day five, Posoperative day six if they stay overnight in the hospital following their surgery
Ability to perform routine activities of daily living
Time frame: Post-opertive day five, Postopertive day six if they stay overnight in the hospital following their surgery
Body Mass Index
Time frame: Obtained at time of admission to hospital
Secondary pain scores using wong-baker faces pain rating scale
Time frame: Post-operative day 5 or post-operative day 6 if they stay overnight following their surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Background: PubMed 20027030Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.
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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.
Amanda M Souza, DO principal investigator
Souza, Amanda, M.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipivacaine 0.5% with epinephrine and Normal Saline in people with Pain, run by Souza, Amanda, M.D. 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 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: withdrawn, as of the sponsor's last update on 5 May 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pain scores using wong-baker faces pain rating scale (time frame: Post-operative day 1 or post-operative day 2 if they stay overnight following their surgery). 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 NCT02230735, 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 5 May 2016.