Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

NCT02890199 | Unknown

• 1 other identifier: HHC-2016-0169
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Visual analog pain scale

  post-operative pain

  1 to 120 hours post-operative

Secondary Outcomes (7)

• Equivalents of morphine used for pain control post-operative while hospitalized

  1-2 days post-operative

• Equivalents of morphine used from the time of hospital discharge to post-operative day 7

  7 days post-operative

• Modified surgical pain scale

  3, 7, 14, 28 days post-operative

• Time to first bowel movement

  1-28 days post-operative

• Post-operative antiemetic use, in hospital

  1-2 days post-operative

Study Arms (2)

Lidocaine group

ACTIVE COMPARATOR

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

Drug: Lidocaine

Bupivacaine liposomal group

EXPERIMENTAL

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

Drug: Bupivacaine liposomal

Interventions

Bupivacaine liposomal DRUG

Bupivacaine liposomal group

Lidocaine DRUG

Lidocaine group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female gender
• Age ≥ 18 years, ≤95 years
• 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
• Able to give informed consent to participate

You may not qualify if:

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

Sponsors & Collaborators

• Hartford Hospital: lead
• American Association of Gynecologic Laparoscopists: collaborator

Study Sites (1)

Hartford Hospital, Urogynecology Division

Hartford, Connecticut, 06106, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Katie Propst, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Propst, MD

CONTACT

860-972-4338; katie.propst@hhchealth.org

David M. O'Sullivan, PhD

CONTACT

david.o'sullivan@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 7, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)