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The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation

Primary Purpose

Postoperative Pain, Pelvic Organ Prolapse, Trigger Point Injection

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
marcaine and kenalog
Sponsored by
Kettering Health Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kettering Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Surgery Alone

Surgery Plus Trigger Point Injection

Arm Description

Patient will receive sacrospinous ligament suspension surgery without any additional interventions

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

Outcomes

Primary Outcome Measures

objective pain score
morphine equivalents

Secondary Outcome Measures

subjective pain score rating
pain scale 0-10 (no pain to severe pain)

Full Information

First Posted
June 20, 2019
Last Updated
October 9, 2023
Sponsor
Kettering Health Network
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1. Study Identification

Unique Protocol Identification Number
NCT03995641
Brief Title
The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation
Official Title
The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Never received appropriate formulation.
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
September 12, 2023 (Actual)
Study Completion Date
September 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kettering Health Network

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Pelvic Organ Prolapse, Trigger Point Injection, Sacrospinous Ligament Fixation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery Alone
Arm Type
No Intervention
Arm Description
Patient will receive sacrospinous ligament suspension surgery without any additional interventions
Arm Title
Surgery Plus Trigger Point Injection
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
marcaine and kenalog
Intervention Description
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 Measure Information:
Title
objective pain score
Description
morphine equivalents
Time Frame
6 weeks postoperative
Secondary Outcome Measure Information:
Title
subjective pain score rating
Description
pain scale 0-10 (no pain to severe pain)
Time Frame
6 weeks postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Kettering Health Network
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation

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