Bupivacaine Injections Into Uterosacral Ligaments During Robotic Assisted Total Hysterectomies

Effectiveness of Bupivacaine With Epinephrine Injections Into the Uterosacral Ligaments for Post-operative Pain Control and the Use of Narcotic Pain Medication Following Robotic Assisted Total Hysterectomies

Will patients that receive injections of Marcaine into the uterine nerve via the uterosacral ligaments experience less pain postoperatively, need less narcotic pain medication and return to activities of daily living sooner.

Study Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Drug: Bipivacaine 0.5% with epinephrine; Drug: Normal Saline

Detailed Description

Gynecologists use paracervical blocks in the office for decreasing pain during office based procedures. Paracervical blocks, in the office, work by injecting the cervix with local anesthetic, typically lidocaine, at the area of the uterosacral ligaments. The uterosacral ligaments contain the uterine nerve, which branches off of levels T12-L2. By injecting the uterine nerve with the local anesthetic patients are better able to tolerate the procedure and have decreased pain post procedure. In the office, paracervical blocks are performed vaginally with injections at the 3 o'clock and 9 o'clock position of the cervix. The use of paracervical blocks by Chudnoff et al reviewed the effectiveness of paracervical blocks in office based procedures, however no one has evaluated the effectiveness of injecting the uterosacral ligaments under direct visualization with the camera that is placed into the abdomen during a robotic assisted gynecologic procedure. We propose that by injecting the uterosacral ligaments and thus the uterine nerve during robotic assisted hysterectomies with Marcaine (Bupivacaine 0.5% with epinephrine 1:200,000) we can offer patients superior pain relief. The onset of action with Marcaine is rapid and anesthesia is long lasting. The duration of anesthesia is significantly longer with Marcaine than any other commonly used local anesthetic. It has also been noted that there is a period of analgesia that persists after the return of sensation, during which time the need for strong analgesics is reduced. By injecting Marcaine we hypothesize that patients will have decreased pain and need less narcotic pain medication. This will allow the patient to return to normal activities of daily living sooner.

This is a randomized controlled double blinded trial in which patients will be assigned to receive saline (control group) or bupivacaine 0.5% with epinephrine 1:200,000 (treatment group). The randomization will be performed through a computerized system in the pharmacy at the pharmacy of the hospital where the study is occurring. The randomization will occur once the patient has consented to the study. The treatment arm of the study will receive a total injection of 14ml of bupivacaine with 7ml directed into the right uterosacral ligament and 7ml into the left uterosacral ligament. The control arm of the study will receive a total injection of 14ml of normal saline with 7ml directed into the right uterosacral ligament and 7ml into the left uterosacral ligament. These injections will take place after the uterus and cervix have been surgically removed and the vaginal cuff has been surgically closed.

The maximum dose of bupivacaine with epinephrine is 225mg. The total amount of bupivacaine that we have chosen to inject is below the maximum allowable dosing and yet we believe will be an adequate amount for providing pain relief.

Eligible patients will be consented for the study while in the preoperative holding area. Once consented the patient will be given a medication diary form that they will take home. The form asks the patient to fill in the name of pain medication that they were prescribed and the dosage. They will also have an area for them to tally the number of pills they have taken since being discharged from the hospital. If they take anything for pain other than that prescribed by the physician who performed the surgery the patient will be taken out of the study. The Wong-baker faces pain rating scale is included on the form which they will be using to rate their pain during the telephone encounters.

The pharmacy will be notified once consent is obtained that the patient is participating in the study. After which, the injectable solution will be sent to the OR labeled "Study Drug." The surgical team and the patient will be blinded to which arm they are assigned to. With the use of a Bierman needle the solution will be injected into the uterine nerve as it courses with the uterosacral ligaments on each side at the level of the vaginal cuff. If the uterosacral ligaments cannot be easily identified, the patient will be excluded from the study.

Follow up will take place via telephone encounters.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • Botsford General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients undergoing robotically assisted total hysterectomies with cystoscopy and with or without procedures involving the adnexa (salpingectomies and salpingo-oophorectomies)

Exclusion Criteria:

• Patients undergoing single incision procedures, those having supracervical hysterectomies and additional procedures involving their pelvic floor (including bladder neck suspension, anterior colophorraphy, posterior colophorraphy, perinealplasty) and sacracolpopexy
• Patients with allergies to bupivacaine and its derivatives
• Patients taking monoamine oxidase inhibitors or tricyclic antidepressants
• Patients with known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
• Patients with abnormal ECG's and prolonged QT syndrome
• Patients who are currently requiring narcotic pain medication or use narcotic pain medications regularly (more than twice weekly)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bipivacaine 0.5% with epinephrine; Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament	Drug: Bipivacaine 0.5% with epinephrine; Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament; Other Names: Marcaine With Epinephrine 1:200,000
Placebo Comparator: Normal Saline; Total of 14 ml of normal saline, 7ml into the right uterosacral ligament and 7ml into the left uterosacral ligament	Drug: Normal Saline; (placebo for bupivacaine); Other Names: 0.7%NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores using wong-baker faces pain rating scale	Follow up will take place via telephone encounters on post-operative day number one, unless the patient is admitted overnight following the surgery which in that case the telephone encounters will take place on postoperative day two. The patient will be asked to rate their average pain score for that day using the Wong-Baker faces pain rating scale which will occur at the time of the phone encounter.	Post-operative day 1 or post-operative day 2 if they stay overnight following their surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type and amount of narcotic pain medication used to achieve pain relief	The type and amount of narcotic pain medication used to achieve pain relief which will be documented using the medication diary given to patients prior to discharge home from the hospital.	Post-operative day number one and five. Post-opertive day two and six if they stay overnight following their surgery
Pain compared to a prior laparoscopic or robotic surgery	Patient will be asked if they have ever had a laparoscopic or robotic surgery before and if they have how does their current pain with this surgery compare to their previous surgery. They will choose from the following answer choices: Worse, Better, No difference, Can not Recall.	Post-operative day one and five, post-operative day two and six if they stay overnight in the hospital following their surgery
Ability to drive	Patient will be asked if they have been able to drive since their surgery. If they have been able to drive we will ask how many days after surgery were they able to start driving.	Post-operative day five, Postopertive day six if they stay overnight in the hospital following their surgery
Ability to perform household duties	On postoperative day five patient will be asked if they have been able to perform household duties. If their answer is yes they will then be asked how man days after their surgery were they able to start performing household duties	Post-operative day five, Posoperative day six if they stay overnight in the hospital following their surgery
Ability to perform routine activities of daily living	Patient will be asked if they have begun performing activities of daily living (i.e grooming, hygiene care, preparing meals). If patient says yes we will follow up asking the patient how many days after their surgery were they able to perform routine activities of daily living.	Post-opertive day five, Postopertive day six if they stay overnight in the hospital following their surgery
Body Mass Index	Patient will be weighed upon admission to the hospital and asked what their height is at which time a BMI will be calculated.	Obtained at time of admission to hospital
Secondary pain scores using wong-baker faces pain rating scale	The second follow up will take place via telephone encounters on post-operative day number five, unless the patient is admitted overnight following the surgery which in that case the telephone encounters will take place on postoperative days six. The patient will be asked to rate their average pain score for that day using the Wong-Baker faces pain rating scale which will occur at the time of the phone encounter.	Post-operative day 5 or post-operative day 6 if they stay overnight following their surgery

Collaborators and Investigators

• Sponsor: Souza, Amanda, M.D.
• Investigators: Principal Investigator: Amanda M Souza, DO, Souza, Amanda, M.D.

Publications and helpful links

General Publications

• Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 29, 2014
• First Posted (Estimate): September 3, 2014

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Robotic; Bupivacaine; Hysterectomy; Uterosacral; Robotic hysterectomy pain control
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: SouzaA