Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

Not Applicable

• Conditions: Pelvic Organ Prolapse
• Interventions: Drug: Bupivacaine liposomal; Drug: Lidocaine

• Registration Number: NCT02890199
• Lead Sponsor: Hartford Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Status Verified: 2016-10
• Study Start: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine liposomal group	Bupivacaine liposomal	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
Lidocaine group	Lidocaine	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

Primary Outcome Measures

Name	Time	Method
Visual analog pain scale	1 to 120 hours post-operative	post-operative pain

Secondary Outcome Measures

Name	Time	Method
Equivalents of morphine used for pain control post-operative while hospitalized	1-2 days post-operative	Post-operative opioid use, in hospital
Equivalents of morphine used from the time of hospital discharge to post-operative day 7	7 days post-operative	Post-operative opioid use, after hospital discharge
Modified surgical pain scale	3, 7, 14, 28 days post-operative	Return to baseline pain status
Time to first bowel movement	1-28 days post-operative	Days to first postoperative bowel movement
Post-operative antiemetic use, in hospital	1-2 days post-operative
Void trial	1-2 days post-operative	Results of in-hospital void trial
HCHAPS pain questionnaire	48 hours post-operative	Patient satisfaction with pain control

Trial Locations

Locations (1)

Hartford Hospital, Urogynecology Division; 🇺🇸 Hartford, Connecticut, United States