Paracervical Block in Laparoscopic Hysterectomy

Brief Title

Paracervical Block in Laparoscopic Hysterectomy

Official Title

A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Paracervical Block Before Total Laparoscopic Hysterectomy for Postoperative Pain Control (PALAPA):

Brief Summary

      It remains controversial whether paracervical block should be performed as a powerful
      strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing
      conclusions are difficult to draw because of the heterogeneous and contradictory nature of
      the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical
      blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on
      postoperative pain relief.
    

Detailed Description

      Postoperative pain management is an important component of patient care and satisfaction
      after surgery. Although contemporary changes such as a shift to minimally invasive approaches
      and an introduction of the enhanced recovery after surgery (ERAS) program have resulted in
      improved outcomes, a large number of patients undergoing surgery have still inadequate pain
      control. Paracervical block is a single-injection of anesthetic around the cervix at a depth
      of about 1 cm, diffusing anesthetic into the second to fourth sacral nerve roots passing
      through Frankenhäuser plexus. Moreover, recent randomized trials demonstrated that patients
      who underwent vaginal hysterectomy and received a paracervical block had lower postoperative
      pain in the first 3-6 hours compared with placebo.

      However, it remains controversial whether paracervical block should be performed as a
      powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because
      convincing conclusions are difficult to draw because of the heterogeneous and contradictory
      nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of
      paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic
      conditions on postoperative pain relief.
    

Study Type

Interventional

Primary Outcome

Postoperative pain

Secondary Outcome

 Frequency of pills/injections requested

Condition

Uterine Fibroid

Intervention

Paracervical block

Study Arms / Comparison Groups

 Paracervical block with 5% bupivacaine

Description:  The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

86

Start Date

February 21, 2019

Completion Date

February 1, 2021

Primary Completion Date

February 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  age between 18 and 65 years

          -  American Society of Anesthesiologists physical status (ASAPS) classification I-II

          -  the absence of pregnancy at the time of surgery

        Exclusion Criteria:

          -  history of cervical surgery such as conization or cerclage

          -  inability to perform the paracervical block due to anatomical abnormalities (i.e.,
             very atrophic or small cervix)

          -  allergy to bupivacaine, planned concomitant surgical procedures involving extensive
             additional tissue manipulation such as pelvic lymph node dissection

          -  any concomitant surgery of pelvic floor repair (uterosacral ligament suspension or
             sacrocolpopexy) or vaginal procedures (anterior or posterior colporrhaphy or
             mid-urethral slings), previously taking opioids for chronic pain

          -  inability to accurately express their pain
      

Gender

Female

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Taejong Song, M.D., Ph.D., +821040358405, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT03792009

Organization ID

2019-01-001

Responsible Party

Principal Investigator

Study Sponsor

Kangbuk Samsung Hospital

Study Sponsor

Taejong Song, M.D., Ph.D., Principal Investigator, Kangbuk Samsung Hospital

Verification Date

February 2019