Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-31

Brief Summary

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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:

1. Lidocaine group (short-acting medication).
2. 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:

1. post-operative opioid medication use
2. return to baseline pain status
3. post-operative time to first bowel movement
4. post-operative antiemetic use (nausea medication)
5. results of voiding trial after surgery
6. patient satisfaction with pain control

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Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Lidocaine group

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Bupivacaine liposomal group

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

Group Type EXPERIMENTAL

Bupivacaine liposomal

Intervention Type DRUG

Interventions

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Bupivacaine liposomal

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female gender
2. Age ≥ 18 years, ≤95 years
3. 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
4. Able to give informed consent to participate

Exclusion Criteria

1. Male
2. Age \<18 years, \> 95 years
3. Unable or unwilling to give informed consent to participate
4. Pregnancy
5. History of chronic pelvic pain, narcotic abuse, or daily narcotic usage in the last six months
6. Known allergy / intolerance to either lidocaine, bupivacaine liposomal, ketorolac, motrin, or acetaminophen
7. Known renal or hepatic insufficiency
8. Planned hysterectomy at the time of prolapse repair
9. Planned transobturator mid urethral sling at the time of prolapse repair

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No