Bupivacaine Injections Into Uterosacral Ligaments During Robotic Assisted Total Hysterectomies

NCT02230735 | Withdrawn

• 1 other identifier: SouzaA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Robotic; Hysterectomy; Uterosacral; Bupivacaine; Robotic hysterectomy pain control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Type and amount of narcotic pain medication used to achieve pain relief

  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

  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

  Post-operative day five, Postopertive day six if they stay overnight in the hospital following their surgery

• Ability to perform 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

  Post-opertive day five, Postopertive day six if they stay overnight in the hospital following their surgery

Study Arms (2)

Bipivacaine 0.5% with epinephrine

EXPERIMENTAL

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

Normal Saline

PLACEBO COMPARATOR

Total of 14 ml of normal saline, 7ml into the right uterosacral ligament and 7ml into the left uterosacral ligament

Drug: Normal Saline

Interventions

Bipivacaine 0.5% with epinephrine DRUG

Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament

Also known as: Marcaine With Epinephrine 1:200,000

Bipivacaine 0.5% with epinephrine

Normal Saline DRUG

(placebo for bupivacaine)

Also known as: 0.7%NS

Normal Saline

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Souza, Amanda, M.D.: lead

Study Sites (1)

Botsford General Hospital

Farmington Hills, Michigan, 48336, United States

Location

Related Publications (1)

• 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.

  PMID: 20027030 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Epinephrine; Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anilides; Amides; Aniline Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Amanda M Souza, DO

  Souza, Amanda, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: September 3, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

US (1)