Pelvic Organ ProlapseNCT02890199
Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
A study testing Bupivacaine liposomal and Lidocaine in people with Pelvic Organ Prolapse, run by Hartford Hospital at 1 site in United States.
Trial summary
During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into the vaginal tissues to help with tissue dissection. It is common that anesthetic medication is mixed into this fluid to help with pain control after surgery. Usually the pain medication injected is short-acting. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Bupivacaine liposomal and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jul 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 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender
- Age ≥ 18 years, ≤95 years
- Planned vaginal sacrospinous ligament fixation with anterior and/or posterior colporrhaphy (SSLF APC) to treat pelvic organ prolapse with or without retropubic mid urethral sling
- Able to give informed consent to participate
Who cannot join
- Male
- Age <18 years, > 95 years
- Unable or unwilling to give informed consent to participate
- Pregnancy
- History of chronic pelvic pain, narcotic abuse, or daily narcotic usage in the last six months
- Known allergy / intolerance to either lidocaine, bupivacaine liposomal, ketorolac, motrin, or acetaminophen
Show all 9Show fewer
- Known renal or hepatic insufficiency
- Planned hysterectomy at the time of prolapse repair
- Planned transobturator mid urethral sling at the time of prolapse repair
Trial locations and contacts
1 site in 1 country.
David M. O'Sullivan, PhD contact
United States1 site, 1 recruiting
- Recruiting
Hartford Hospital, Urogynecology Division
Hartford, Connecticut, 06106
Katie Propst, MD, 860-972-4338, katie.propst@hhchealth.org
About this study
During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into the vaginal tissues to help with tissue dissection. It is common that anesthetic medication is mixed into this fluid to help with pain control after surgery. Usually the pain medication injected is short-acting. In this study the investigators plan to compare the usual short-acting injected pain medication with a long-acting injected pain medication to evaluate whether this improves pain control after surgery.
One type surgical procedure for prolapse will be evaluated. The procedure is sacrospinous ligament fixation. This is suspension of the vagina to treat pelvic organ prolapse. Study participants will be randomized to one of two study groups:
Read more
- Lidocaine group (short-acting medication).
- Liposomal bupivacaine group (long-acting medication)
Information will be collected on study participants, including: demographics, procedure data, and post-operative information. The primary outcome of this study is determine if use of long-acting injected local anesthesia at the time of sacrospinous ligament fixation leads to less post-operative pain compared to short-acting local anesthesia.
Secondary outcomes include:
- post-operative opioid medication use
- return to baseline pain status
- post-operative time to first bowel movement
- post-operative antiemetic use (nausea medication)
- results of voiding trial after surgery
- patient satisfaction with pain control
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Bupivacaine liposomal, Lidocaine
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine liposomalDrug
LidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Active comparator | 0.5% lidocaine mixed with 1:200,000 epinephrine 70 milliliters (mL) will be used for local injection at the sacrospinous ligament and for anterior / posterior colporrhaphy Receives: Drug: Lidocaine |
| Bupivacaine liposomal group | Experimental | 1.3% bupivacaine liposomal (20 mL) injected at the sacrospinous ligament 0.5% lidocaine mixed with 1:200,000 epinephrine 50mL for the anterior / posterior colporrhaphy Receives: Drug: Bupivacaine liposomal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog pain scale
post-operative pain
Measured: 1 to 120 hours post-operative
Secondary outcomes (7)
Equivalents of morphine used for pain control post-operative while hospitalized
Post-operative opioid use, in hospital
Measured: 1-2 days post-operative
Equivalents of morphine used from the time of hospital discharge to post-operative day 7
Post-operative opioid use, after hospital discharge
Measured: 7 days post-operative
Modified surgical pain scale
Return to baseline pain status
Measured: 3, 7, 14, 28 days post-operative
Time to first bowel movement
Days to first postoperative bowel movement
Measured: 1-28 days post-operative
Post-operative antiemetic use, in hospital
Measured: 1-2 days post-operative
Void trial
Results of in-hospital void trial
Measured: 1-2 days post-operative
HCHAPS pain questionnaire
Patient satisfaction with pain control
Measured: 48 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Gynecologic Laparoscopists
- Responsible party
- Principal investigator, Katie Propst, Hartford Hospital
- Investigators
- Katie Propst, MD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890199
- Sponsor's protocol ID
- HHC-2016-0169
- Status last verified
- Oct 2016
- First submitted
- 26 Aug 2016
- Last updated
- 12 Oct 2016
- 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 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
- ClinicalTrials.gov ID
- NCT02890199
- Acronym / sponsor ID
- HHC-2016-0169
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- American Association of Gynecologic Laparoscopists
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 7 Sep 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.
During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into the vaginal tissues to help with tissue dissection. It is common that anesthetic medication is mixed into this fluid to help with pain control after surgery. Usually the pain medication injected is short-acting. In this study the investigators plan to compare the usual short-acting injected pain medication with a long-acting injected pain medication to evaluate whether this improves pain control after surgery.
One type surgical procedure for prolapse will be evaluated. The procedure is sacrospinous ligament fixation. This is suspension of the vagina to treat pelvic organ prolapse. Study participants will be randomized to one of two study groups:
- Lidocaine group (short-acting medication).
- Liposomal bupivacaine group (long-acting medication)
Information will be collected on study participants, including: demographics, procedure data, and post-operative information. The primary outcome of this study is determine if use of long-acting injected local anesthesia at the time of sacrospinous ligament fixation leads to less post-operative pain compared to short-acting local anesthesia.
Secondary outcomes include:
- post-operative opioid medication use
- return to baseline pain status
- post-operative time to first bowel movement
- post-operative antiemetic use (nausea medication)
- results of voiding trial after surgery
- patient satisfaction with pain control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Active comparator | Drug: Lidocaine0.5% lidocaine mixed with 1:200,000 epinephrine 70 milliliters (mL) will be used for local injection at the sacrospinous ligament and for anterior / posterior colporrhaphy |
| Bupivacaine liposomal group | Experimental | Drug: Bupivacaine liposomal1.3% bupivacaine liposomal (20 mL) injected at the sacrospinous ligament 0.5% lidocaine mixed with 1:200,000 epinephrine 50mL for the anterior / posterior colporrhaphy |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female gender
- Age ≥ 18 years, ≤95 years
- Planned vaginal sacrospinous ligament fixation with anterior and/or posterior colporrhaphy (SSLF APC) to treat pelvic organ prolapse with or without retropubic mid urethral sling
- Able to give informed consent to participate
Key exclusion criteria (9 listed)
- Male
- Age <18 years, > 95 years
- Unable or unwilling to give informed consent to participate
- Pregnancy
- History of chronic pelvic pain, narcotic abuse, or daily narcotic usage in the last six months
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 |
|---|---|---|
| Bupivacaine liposomal | Drug | Bupivacaine liposomal group |
| Lidocaine | Drug | Lidocaine group |
Primary outcome
Visual analog pain scale
Time frame: 1 to 120 hours post-operative
post-operative pain
7 secondary outcomes
Equivalents of morphine used for pain control post-operative while hospitalized
Time frame: 1-2 days post-operative
Equivalents of morphine used from the time of hospital discharge to post-operative day 7
Time frame: 7 days post-operative
Modified surgical pain scale
Time frame: 3, 7, 14, 28 days post-operative
Time to first bowel movement
Time frame: 1-28 days post-operative
Post-operative antiemetic use, in hospital
Time frame: 1-2 days post-operative
Void trial
Time frame: 1-2 days post-operative
HCHAPS pain questionnaire
Time frame: 48 hours post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
David M. O'Sullivan, PhD contact
Katie Propst, MD principal investigator
Hartford 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 liposomal and Lidocaine in people with Pelvic Organ Prolapse, run by Hartford Hospital 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 4 inclusion and 9 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 12 Oct 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. 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?
Contact Katie Propst, MD (860-972-4338, katie.propst@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog pain scale (time frame: 1 to 120 hours post-operative). 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 12 Oct 2016.