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The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation: A Randomized Trial

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ClinicalTrials.gov Identifier: NCT03995641
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Ashley Seidner, Kettering Health Network

Brief 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 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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Pelvic Organ Prolapse Trigger Point Injection Sacrospinous Ligament Fixation Drug: marcaine and kenalog Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation: A Randomized Trial
Actual Study Start Date : February 2, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
No Intervention: Surgery Alone
Patient will receive sacrospinous ligament suspension surgery without any additional interventions
Experimental: Surgery Plus Trigger Point Injection
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
Drug: marcaine and kenalog
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




Primary Outcome Measures :
  1. objective pain score [ Time Frame: 6 weeks postoperative ]
    morphine equivalents


Secondary Outcome Measures :
  1. subjective pain score rating [ Time Frame: 6 weeks postoperative ]
    pain scale 0-10 (no pain to severe pain)



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995641


Contacts
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Contact: Janelle M Evans, MD (937)298-3399 janelle.evans@ketteringhealth.org
Contact: Ashley E Seidner, DO ashley.seidner@ketteringhealth.org

Locations
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United States, Ohio
Kettering Health Network Recruiting
Dayton, Ohio, United States, 45459
Contact: Ashley E Seidner, DO       ashley.seidner@ketteringhealth.org   
Sponsors and Collaborators
Kettering Health Network
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Responsible Party: Ashley Seidner, OB/GYN resident, Kettering Health Network
ClinicalTrials.gov Identifier: NCT03995641    
Other Study ID Numbers: 19-002
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Triamcinolone Acetonide
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors