Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

Pelvic Organ Prolapse Clinical Trial

Official title:

Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02890199
• Other study ID #: HHC-2016-0169
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2016
• Last updated: October 11, 2016
• Start date: October 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: Hartford Hospital
• Contact: Katie Propst, MD
• Phone: 860-972-4338
• Email: katie.propst[@]hhchealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Pelvic Organ Prolapse
• Prolapse

Intervention

Drug:
• Bupivacaine liposomal

• Lidocaine

Locations

Country	Name	City	State
United States	Hartford Hospital, Urogynecology Division	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	American Association of Gynecologic Laparoscopists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog pain scale	post-operative pain	1 to 120 hours post-operative	No
Secondary	Equivalents of morphine used for pain control post-operative while hospitalized	Post-operative opioid use, in hospital	1-2 days post-operative	No
Secondary	Equivalents of morphine used from the time of hospital discharge to post-operative day 7	Post-operative opioid use, after hospital discharge	7 days post-operative	No
Secondary	Modified surgical pain scale	Return to baseline pain status	3, 7, 14, 28 days post-operative	No
Secondary	Time to first bowel movement	Days to first postoperative bowel movement	1-28 days post-operative	No
Secondary	Post-operative antiemetic use, in hospital		1-2 days post-operative	No
Secondary	Void trial	Results of in-hospital void trial	1-2 days post-operative	No
Secondary	HCHAPS pain questionnaire	Patient satisfaction with pain control	48 hours post-operative	No