Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

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

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Drug: Lidocaine; Drug: Bupivacaine liposomal

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Propst, MD; Phone Number: 860-972-4338; Email: katie.propst@hhchealth.org
• Study Contact Backup: Name: David M. O'Sullivan, PhD; Email: david.o'sullivan@hhchealth.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Hartford Hospital, Urogynecology Division
      • Contact: Katie Propst, MD; Phone Number: 860-972-4338; Email: katie.propst@hhchealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Drug: Lidocaine
EXPERIMENTAL: 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	Drug: Bupivacaine liposomal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog pain scale	post-operative pain	1 to 120 hours post-operative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Collaborators: American Association of Gynecologic Laparoscopists
• Investigators: Principal Investigator: Katie Propst, MD, Hartford Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): July 1, 2017

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (ESTIMATE): September 7, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Pain, Postoperative; Prolapse; Pelvic Organ Prolapse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: HHC-2016-0169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO