Reducing Post-Op Pain After Sacrospinous Ligament Colpopexy

This is a randomized double-blind clinical trial. Potential subjects will be identified by
members of the Center for Urogynecology and Pelvic Reconstructive Surgery at the Cleveland
Clinic main campus. Eligible patients that agree to participate will be provided written
informed consent administered by the collaborators listed on the IRB at the Cleveland Clinic
main campus.

All subjects will be predetermined by their surgeon to undergo sacrospinous ligament
colpopexy for management of vaginal apex prolapse after hysterectomy. The participants will
then be randomized to one of two groups: "local analgesia injection" or "normal saline
injection" according to a computer-generated randomization schedule with random block sizes
with the use of the SAS statistical software package (SAS Institute, Cary, NC). Randomization
will be done by a nurse coordinator who will not be involved in participant recruitment or
injection at the time of surgery. All patients and providers will be blinded to their
assignment. The assignment will be kept in an envelope which will be given to the pharmacy
the day of the patient's scheduled procedure. The pharmacy will then dispense the correct
intervention based on the randomization.

In addition to a standardized evaluation including the history and physical examination,
patients will be asked to complete a functional assessment questionnaire as well as a
surgical pain scale at the preoperative visit. Prior to discharge from the hospital, patients
will be provided with an envelope with pre-labeled questionnaires to bring home with them.
Prior to discharge, they will be asked to complete the surgical pain scale only. Subjects
will then be called the day after discharge, at week 1, week 2, week 4 and week 6 after the
procedure and will be reminded to complete the appropriate questionnaires/forms that were
provided to them. They will bring in these forms to their 6-week postoperative visit. All
questionnaires will be self-administered. Completion of these questionnaires is the only
additional assessment that is specific to participation in this study and is not usually
included as part of the standard care of sacrospinous ligament colpopexy.

Sacrospinous ligament colpopexy will be performed in a standard fashion. The approach is done
by either entering the vagina along the anterior or posterior wall or at the apex. Approach
and side of the suspension will be based on surgeon's preference. Prior to entry, the apex of
the vaginal vault is first identified by visualizing the old hysterectomy scar. Allis clamps
are used to demarcate the new vaginal apex and to ensure that this apex will suspend
adequately to the sacrospinous ligament, which is identified transvaginally by palpation of
the ischial spine. Once vaginal entry is made, sharp and blunt dissection are performed down
to the pararectal space on one or both sides. Identification of the ischial spine confirms
the position of the coccygeus-sacrospinous ligament complex. Once the complex is freed of any
overlying areolar tissue, a Briesky Navratil retractor is placed to retract the rectum away
from the site of suture placement and to help with visualization of the ligament complex.

The CapioTM device is then used to place the suspension sutures. 3 sutures are placed: 2
delayed-absorbable (0 PDS) and 1 permanent (0 prolene). All sutures are placed one and a half
to two fingerbreadths (2-3cm) medial to the ischial spine in a sequential fashion. After
placement, a rectal exam is done to ensure that no sutures have been placed through the
rectum and the coccygeus-sacrospinous ligament complex is visualized carefully to ensure that
the surgical site is hemostatic. The absorbable-delayed suspension sutures are placed through
the vaginal epithelium at the level of the neoapex and all permanent sutures are placed
through the subepithelial tissue.

Injection of the sacrospinous ligament will be performed prior to tying down the suspension
sutures according to the group the patient is randomized to. A pudendal nerve block kit
needle and syringe will be used to administer the injection. The spacer will be removed,
allowing the needle point to enter the ligament 10mm in depth with each injection. The
injection will be placed in 3 locations (~3mL in each injection for a total of 10mL) along
the center of the sacropinous ligament under each previously placed suture. Proper injection
technique will be performed with each injection (e.g. there will be confirmation of
extravascular placement of the needle tip prior to each injection). One of two injections
(bupivacaine vs. normal saline) delivered by the pharmacy will be administered depending upon
the group to which the patient has been randomized.

Preoperative data will include the following:

- Patient age, race, vaginal parity, menopausal sate, tobacco use, BMI, prior prolapse
surgery, preoperative prolapse stage (see Appendix for demographic data sheet)

- Assessment of functional status, surgical pain scale

- Labs (Hb/Hct)

Intraoperative data will include the following:

- Surgery date

- Surgeon

- Side of Colpopexy

- Concomitant procedures

- EBL

Postoperative data will include the following:

- Days in the hospital

- Pain medication requirment during hospitalization

- Prior to discharge from hospital: surgical pain scale; localization of pain

- POD#1: Labs (Hb/Hct)

- Time from surgery [incision] to discharge (hours)

- 1st postoperative week oDaily surgical pain scale with localization of pain oDaily pain
medication use oAt end of week 1: Assessment of functional status

- 2nd postoperative week oDaily surgical pain scale with localization of pain oDaily pain
medication use oAt end of week 2: Assessment of functional status

- 4th postoperative week (at end of week 4) oAssessment of functional status oSurgical
pain scale with localization of pain

- 6th postoperative week (at end of week 6) oAssessment of functional status oSurgical
pain scale with localization of pain

- Date of 6-week postoperative

- Need for intervention for pain: trigger point injection, PFPT referral, reoperation

All paper forms used for data collection will be kept in a research cabinet dedicated to this
project which will be locked at all times, in a locked office at the Cleveland Clinic. All
forms will contain de-identified information - identification numbers will correspond to the
subjects listed in the master excel file.

All study data will be transferred and managed electronically using REDCap (Research
Electronic Data Capture). Each subject will be entered into REDCap using the assigned
identification number from the master excel file. REDCap is a secure, web-based application
designed to support data capture for research studies, providing user-friendly web-based case
report forms, real-time data entry validation, audit trials, and a de-identified data export
mechanism to common statistical packages. They system was developed by a multi-institutional
consortium which was initiated at Vanderbilt University and includes the Cleveland Clinic.
The database is hosted at the Cleveland Clinic Research Datacenter in the JJN basement and is
managed by the Quantitative Health Sciences Department. The system is protected by a login
and Secure Sockets Layers (SSL) encryption. Data collection is customized for each study as
based on a study-specific data dictionary defined by the research team with guidance from the
REDCap administrator in Quantitative Health Sciences at the Cleveland Clinic

Inclusion Criteria:

- Age ≥ 18, who are to undergo sacrospinous ligament colpopexy for vaginal apex prolapse
after hysterectomy

- Other concomitant prolapse and anti-incontinence procedures (e.g., anterior
colporrhaphy, paravaginal defect repair, posterior colporrhaphy, or mid-urethral sling
procedures) will be performed at the primary surgeon's discretion

Exclusion Criteria:

- Inability to comprehend written and/or spoken English

- Inability to provide informed consent

- Need for concomitant surgeries not related to pelvic organ prolapse or incontinence

- Chronic pain conditions (e.g., fibromyalgia, myositis, myofascial pain syndrome)