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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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
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.

United States1 site
  • Kettering Health Network

    Dayton, Ohio, 45459

Other trials in United States

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.

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 groups in NCT03995641
Study groupRoleWhat they receive
Surgery AloneNo interventionPatient will receive sacrospinous ligament suspension surgery without any additional interventions
Surgery Plus Trigger Point InjectionExperimentalPatient 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.

  1. objective pain score

    morphine equivalents

    Measured: 6 weeks postoperative

Secondary outcomes (1)
  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.

  1. First posted24 Jun 2019
  2. Study start2 Feb 2019
  3. Primary completion12 Sep 2023
  4. Study completion12 Sep 2023

Why it stopped: Never received appropriate formulation.

Resources

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)
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

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.

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