Postoperative PainPhase 4NCT03995641
The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation
A Phase 4 study testing marcaine and kenalog in people with Postoperative Pain and Pelvic Organ Prolapse, run by Kettering Health Network at 1 site in United States.
Trial summary
This study will randomize patients to either receive intraoperative administration of local anesthetic and corticosteriod at time of sacrospinous ligament fixation compared to placebo to determine if intraoperative trigger point injection (TPI) improves postoperative gluteal and sciatic pain scores along with use of… 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
- Postoperative Pain, Pelvic Organ Prolapse, Trigger Point Injection
- What is being tested?
- marcaine and kenalog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2019to 12 Sep 2023
- Phase
- Phase 4
- 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
- 21yo or older
- English speaking
- Stage II or greater pelvic organ prolapse
- Sacrospinous Ligament Fixation (SSLF) used as apical suspension
- SSLF scheduled to be performed by Dr. Janelle Evans or Dr. Marc Ashby
Who cannot join
- Under 21yo
- Non English speaking
- Patient consented, but SSLF not performed at time of surgery
- Patient on chronic opiates preoperatively (greater than three months of use)
- Contraindication to Marcaine or Kenalog
- Prisoners and those involuntarily confined
- Patients with cognitive impairment or those using a legally-authorized representative
- Hysterectomy performed at time of suspension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation: A Randomized Trial
This study will randomize patients to either receive intraoperative administration of local anesthetic and corticosteriod at time of sacrospinous ligament fixation compared to placebo to determine if intraoperative trigger point injection (TPI) improves postoperative gluteal and sciatic pain scores along with use of narcotic pain medications.
There is a paucity of data examining interventions to potentially ameliorate the postoperative gluteal pain often associated with sacrospinous ligament colpopexy. Our study aims to determine if a compounded TPI improves postoperative pain scores and minimizes use of narcotic pain medications by 20% compared to controls.
Read the detailed description
Sacrospinous ligament fixation (SSLF) is commonly performed to treat apical prolapse. Pelvic organ prolapse (POP) is a complaint for which as many as 11% of women seek surgical intervention in their lifetimes (2). SSLF is associated with shorter operating time, improved patient recovery time, fewer complications and decreased costs compared to an abdominal approach (3).This procedure is associated with postoperative nerve pain in 6.1% to 15.3% of SSLF procedures, due to impingement of the S3 to S5 nerve roots that course over the mid-portion of the coccygeus muscle-sacrospinous ligament (C-SSL) complex (1). 89% of the nerve fibers to the coccygeus and/or levator ani muscles (S3) course over the midportion of the C-SSL complex, just proximal to the intended location for suspension (4). This resulting nerve entrapment or injury may then lead to gluteal and perineal pain, parasthesias and muscle weakness (1). This pain may persist 6 weeks in up to 15% of patients,but most patients can be managed with conservative therapies, such as medications, TPIs and/or pelvic floor physical therapy (3).
A myofascial trigger point is a hyperirritable area in skeletal muscle that is painful on compression and can give rise to characteristic referred pain and tenderness, motor dysfunction and autonomic phenomena (5). TPIs are a treatment used in cases of chronic myofascial nerve pain and involve injection of the involved muscle(s), typically with local anesthetics and corticosteroids (5). The mechanism of action of TPIs occurs by mechanical disruption of abnormal contractile elements, dilution of nociceptive substances by the infiltrated anesthetic, and induction of muscle fiber trauma that subsequently releases intracellular potassium. Additionally, injections interrupt the positive feedback loop that perpetuates pain and a vasodilatory effect of anesthetic helps to remove excess metabolites (5). The benefits of this local combined pain control method are two-fold: the local anesthetic offers rapid pain relief for several hours while the corticosteroid provides delayed pain control, often lasting three to five weeks (6). The use of such local analgesia is not typically standard of care at the time of a sacrospinous ligament fixation, but may be a helpful adjunct therapy.
A recent case report noted significant improvement in a patient's pelvic pain after she received three therapeutic pudendal nerve perineal injections using the combination of a local anesthetic and steroid (bupivicaine 0.25% and triamcinolone 40 mg); two injections were placed at the ischial spine and one in Alcock's canal (7). Similarly, another randomized controlled trial found that injection of slow-release corticosteroid (triamcinolone) and lidocaine in the anatomic region around the sacrospinous ligament's insertion on the ischial spine (i.e., also in the area of SSL colpopexy) significantly reduced pain intensity and number of pain locations in women with persistent, debilitating sacral low back pain, even spanning up to two years after pregnancy and childbirth (8).
There is a paucity of data examining interventions to potentially ameliorate the postoperative transient gluteal pain often associated with sacrospinous ligament colpopexy. The only comparable study to date examined the injection of 0.25% bupivicaine at the time of sacrospinous ligament colpopexy and found that such an intervention did not reduce patient's perceptions of postoperative gluteal pain, but did potentially reduce the need for medication after surgery (1). Our study aims to determine if a compounded TPI (9cc 0.5% marcaine and 1cc Kenalog) improves postoperative gluteal pain scores and minimizes use of narcotic pain medications in the postoperative period.
- Conditions
- Postoperative Pain, Pelvic Organ Prolapse, Trigger Point Injection, Sacrospinous Ligament Fixation
- Being tested
- marcaine and kenalog
- Medical subject headings
- Pain, Postoperative, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
marcaine and kenalogDrug
Trigger point injection (consisting of 9 cc 0.5% Marcaine and 1 cc kenalog) may be given at time of surgery if patient is randomized to receive the injection
| Study group | Role | What they receive |
|---|---|---|
| Surgery Alone | No intervention | Patient will receive sacrospinous ligament suspension surgery without any additional interventions |
| Surgery Plus Trigger Point Injection | Experimental | Patient will have sacrospinous ligament suspension procedure with addition of a trigger point injection (9cc of 0.5% marcaine and 1 cc kenalog) over area of suture placement Receives: Drug: marcaine and kenalog |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective pain score
morphine equivalents
Measured: 6 weeks postoperative
Secondary outcomes (1)
subjective pain score rating
pain scale 0-10 (no pain to severe pain)
Measured: 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start2 Feb 2019
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Why it stopped: Never received appropriate formulation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995641
- Sponsor's protocol ID
- 19-002
- Status last verified
- Oct 2023
- First submitted
- 20 Jun 2019
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03995641
- Acronym / sponsor ID
- 19-002
- Conditions
- Postoperative Pain, Pelvic Organ Prolapse, Trigger Point Injection, Sacrospinous Ligament Fixation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never received appropriate formulation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 24 Jun 2019 (actual)
- 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 randomize patients to either receive intraoperative administration of local anesthetic and corticosteriod at time of sacrospinous ligament fixation compared to placebo to determine if intraoperative trigger point injection (TPI) improves postoperative gluteal and sciatic pain scores along with use of narcotic pain medications.
There is a paucity of data examining interventions to potentially ameliorate the postoperative gluteal pain often associated with sacrospinous ligament colpopexy. Our study aims to determine if a compounded TPI improves postoperative pain scores and minimizes use of narcotic pain medications by 20% compared to controls.
Detailed description
Sacrospinous ligament fixation (SSLF) is commonly performed to treat apical prolapse. Pelvic organ prolapse (POP) is a complaint for which as many as 11% of women seek surgical intervention in their lifetimes (2). SSLF is associated with shorter operating time, improved patient recovery time, fewer complications and decreased costs compared to an abdominal approach (3).This procedure is associated with postoperative nerve pain in 6.1% to 15.3% of SSLF procedures, due to impingement of the S3 to S5 nerve roots that course over the mid-portion of the coccygeus muscle-sacrospinous ligament (C-SSL) complex (1). 89% of the nerve fibers to the coccygeus and/or levator ani muscles (S3) course over the midportion of the C-SSL complex, just proximal to the intended location for suspension (4). This resulting nerve entrapment or injury may then lead to gluteal and perineal pain, parasthesias and muscle weakness (1). This pain may persist 6 weeks in up to 15% of patients,but most patients can be managed with conservative therapies, such as medications, TPIs and/or pelvic floor physical therapy (3).
A myofascial trigger point is a hyperirritable area in skeletal muscle that is painful on compression and can give rise to characteristic referred pain and tenderness, motor dysfunction and autonomic phenomena (5). TPIs are a treatment used in cases of chronic myofascial nerve pain and involve injection of the involved muscle(s), typically with local anesthetics and corticosteroids (5). The mechanism of action of TPIs occurs by mechanical disruption of abnormal contractile elements, dilution of nociceptive substances by the infiltrated anesthetic, and induction of muscle fiber trauma that subsequently releases intracellular potassium. Additionally, injections interrupt the positive feedback loop that perpetuates pain and a vasodilatory effect of anesthetic helps to remove excess metabolites (5). The benefits of this local combined pain control method are two-fold: the local anesthetic offers rapid pain relief for several hours while the corticosteroid provides delayed pain control, often lasting three to five weeks (6). The use of such local analgesia is not typically standard of care at the time of a sacrospinous ligament fixation, but may be a helpful adjunct therapy.
A recent case report noted significant improvement in a patient's pelvic pain after she received three therapeutic pudendal nerve perineal injections using the combination of a local anesthetic and steroid (bupivicaine 0.25% and triamcinolone 40 mg); two injections were placed at the ischial spine and one in Alcock's canal (7). Similarly, another randomized controlled trial found that injection of slow-release corticosteroid (triamcinolone) and lidocaine in the anatomic region around the sacrospinous ligament's insertion on the ischial spine (i.e., also in the area of SSL colpopexy) significantly reduced pain intensity and number of pain locations in women with persistent, debilitating sacral low back pain, even spanning up to two years after pregnancy and childbirth (8).
There is a paucity of data examining interventions to potentially ameliorate the postoperative transient gluteal pain often associated with sacrospinous ligament colpopexy. The only comparable study to date examined the injection of 0.25% bupivicaine at the time of sacrospinous ligament colpopexy and found that such an intervention did not reduce patient's perceptions of postoperative gluteal pain, but did potentially reduce the need for medication after surgery (1). Our study aims to determine if a compounded TPI (9cc 0.5% marcaine and 1cc Kenalog) improves postoperative gluteal pain scores and minimizes use of narcotic pain medications in the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery Alone | No intervention | –Patient will receive sacrospinous ligament suspension surgery without any additional interventions |
| Surgery Plus Trigger Point Injection | Experimental | Drug: marcaine and kenalogPatient will have sacrospinous ligament suspension procedure with addition of a trigger point injection (9cc of 0.5% marcaine and 1 cc kenalog) over area of suture placement |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21yo or older
- English speaking
- Stage II or greater pelvic organ prolapse
- Sacrospinous Ligament Fixation (SSLF) used as apical suspension
- SSLF scheduled to be performed by Dr. Janelle Evans or Dr. Marc Ashby
Key exclusion criteria (8 listed)
- Under 21yo
- Non English speaking
- Patient consented, but SSLF not performed at time of surgery
- Patient on chronic opiates preoperatively (greater than three months of use)
- Contraindication to Marcaine or Kenalog
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 and kenalogTrigger point injection (consisting of 9 cc 0.5% Marcaine and 1 cc kenalog) may be given at time of surgery if patient is randomized to receive the injection | Drug | Surgery Plus Trigger Point Injection |
Primary outcome
objective pain score
Time frame: 6 weeks postoperative
morphine equivalents
1 secondary outcome
subjective pain score rating
Time frame: 6 weeks postoperative
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 Feb 2025.
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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 marcaine and kenalog in people with Postoperative Pain and Pelvic Organ Prolapse, run by Kettering Health Network 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 5 inclusion and 8 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 Feb 2025. 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.
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?
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?
objective pain score (time frame: 6 weeks postoperative). 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 5 Feb 2025.