Para-cervical Block Prior to Laparoscopic Hysterectomy as an Adjuvant Treatment to Reduce Postoperative Pain.

NCT03027661 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 16-130
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized controlled trial in which patients that are scheduled to undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using block randomization. The intervention would be performed after the patient is under general anesthesia, prior to starting the surgery. Patients would be consented in the office or preoperative area (before receiving sedatives). As far as the intervention itself, it would consist of injecting 5 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock, which is standard technique for para-cervical block. The remainder of the procedure will then continue in a regular fashion. Alternatively, patients in the control group will be injected with 5 mL of normal saline. The surgeon would be blinded as to patient allocation. Research staff will have previously prepared the formulations (saline or bupivacaine) and have sent them to the operating room prior to beginning the procedure depending on assigned group. At the end of the case, pain will be assessed using a visual analogue scale with a range from 0 to 10 by one of the researches who will also be blinded to the group. This will be done at 30 and 60 minutes after surgical stop time. Additional pain control in the postanesthesia care unit (PACU) will be standardized to all patients. Hypothesis: Performing a para-cervical block with local anesthetic prior to a laparoscopic hysterectomy significantly reduces pain after the procedure

Conditions

Pain, Postoperative

Keywords

para-cervical block; laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (2)

• Pain Reported on the Visual Analogue Scale (VAS) at 30 Minutes Postoperative

  Scale used is the Visual analogue scale for pain. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.

  30 minutes post-operative stop time

• Pain Reported on the Visual Analogue Scale (VAS) at 60 Minutes Postoperative

  Postoperative pain score on the Visual analgoue scale at 60 minutes from surgical stop time. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.

  60 minutes

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock

Drug: 0.9% Sodium Chloride

Study Group

ACTIVE COMPARATOR

Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Inject 10 mL of 0.5% bupivacaine into cervical stroma

Also known as: Marcaine, Sensorcaine

Study Group

0.9% Sodium Chloride DRUG

Inject 10 mL of 0.9% NaCl into cervical stroma

Also known as: Normal Saline

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing laparoscopic hysterectomy with or without salpingoophorectomy for benign indications
• Undergoing laparoscopic hysterectomy with robotic assistance with or without salpingoophorectomy for benign indications
• Between 18 and 60 years of age

You may not qualify if:

• Intraoperative detection of malignancy
• Undergoing additional procedures at the time of surgery (except prophylactic McCall culdoplasty/uterosacral ligament suspension, excision of endometriosis, appendectomy, cystoscopy)
• Inability to perform paracervical block due to anatomic abnormalities (absent/flush cervix)
• Known allergy/sensitivity to bupivacaine
• Intraoperative bowel injury, bladder injury, ureter injury or major vessel injury that required repair.

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Related Publications (14)

• Acton JN, Salfinger SG, Tan J, Cohen PA. Outcomes of Total Laparoscopic Hysterectomy Using a 5-mm Versus 10-mm Laparoscope: A Randomized Control Trial. J Minim Invasive Gynecol. 2016 Jan;23(1):101-6. doi: 10.1016/j.jmig.2015.09.001. Epub 2015 Sep 11.

  PMID: 26371370 BACKGROUND

• Centini G, Calonaci A, Lazzeri L, Tosti C, Palomba C, Puzzutiello R, Luisi S, Petraglia F, Zupi E. Parenterally administered moderate sedation and paracervical block versus general anesthesia for hysteroscopic polypectomy: a pilot study comparing postoperative outcomes. J Minim Invasive Gynecol. 2015 Feb;22(2):193-8. doi: 10.1016/j.jmig.2014.09.008. Epub 2014 Nov 13.

  PMID: 25265887 BACKGROUND

• Donnez O, Donnez J, Dolmans MM, Dethy A, Baeyens M, Mitchell J. Low Pain Score After Total Laparoscopic Hysterectomy and Same-Day Discharge Within Less Than 5 Hours: Results of a Prospective Observational Study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1293-9. doi: 10.1016/j.jmig.2015.06.021. Epub 2015 Jul 11.

  PMID: 26169246 BACKGROUND

• Golembiewski J, Dasta J. Evolving Role of Local Anesthetics in Managing Postsurgical Analgesia. Clin Ther. 2015 Jun 1;37(6):1354-71. doi: 10.1016/j.clinthera.2015.03.017. Epub 2015 Apr 10.

  PMID: 25866297 BACKGROUND

• Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2.

  PMID: 18830553 BACKGROUND

• Ng A, Swami A, Smith G, Davidson AC, Emembolu J. The analgesic effects of intraperitoneal and incisional bupivacaine with epinephrine after total abdominal hysterectomy. Anesth Analg. 2002 Jul;95(1):158-62, table of contents. doi: 10.1097/00000539-200207000-00028.

  PMID: 12088961 BACKGROUND

• O'Neal MG, Beste T, Shackelford DP. Utility of preemptive local analgesia in vaginal hysterectomy. Am J Obstet Gynecol. 2003 Dec;189(6):1539-41; discussion 1541-2. doi: 10.1016/j.ajog.2003.10.691.

  PMID: 14710057 BACKGROUND

• Penninx JP, Mol BW, Bongers MY. Endometrial ablation with paracervical block. J Reprod Med. 2009 Oct;54(10):617-20.

  PMID: 20677480 BACKGROUND

• Skensved H. Combining Paracervical Block With a Complete Fundal Block Significantly Reduces Patients' Perception of Pain During Radio-Frequency Endometrial Ablation in an Office Setting. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S45. doi: 10.1016/j.jmig.2015.08.124. Epub 2015 Oct 15. No abstract available.

  PMID: 27679246 BACKGROUND

• Tangsiriwatthana T, Sangkomkamhang US, Lumbiganon P, Laopaiboon M. Paracervical local anaesthesia for cervical dilatation and uterine intervention. Cochrane Database Syst Rev. 2013 Sep 30;2013(9):CD005056. doi: 10.1002/14651858.CD005056.pub3.

  PMID: 24085642 BACKGROUND

• ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-1158. doi: 10.1097/AOG.0b013e3181c33c72.

  PMID: 20168127 BACKGROUND

• Wong-Baker FACES Foundation (2016). Wong-Baker FACES® Pain Rating Scale. Retrieved 11/10/2016 with permission from http://www.WongBakerFACES.org

  BACKGROUND

• Mercier RJ, Zerden ML. Intrauterine anesthesia for gynecologic procedures: a systematic review. Obstet Gynecol. 2012 Sep;120(3):669-77. doi: 10.1097/AOG.0b013e3182639ab5.

  PMID: 22914480 BACKGROUND

• Radtke S, Boren T, Depasquale S. Paracervical Block as a Strategy to Reduce Postoperative Pain after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2019 Sep-Oct;26(6):1164-1168. doi: 10.1016/j.jmig.2018.12.001. Epub 2018 Dec 6.

  PMID: 30528725 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Elaine Todd, Director of Sponsored Programs - Contracts and research agreements
• Organization: University of Tennessee Health and Science Center

ElaineTodd@uthsc.edu

9014483303

Study Officials

• Steven J Radtke, MD

  UT College of Medicine MIGS Fellow & Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 23, 2017
• Study Start: August 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: November 15, 2018
• Results First Posted: November 15, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)