Paracervical Block in Laparoscopic Hysterectomy

Not Applicable

• Conditions: Uterine Fibroid; Adenomyosis
• Interventions: Device: Paracervical block; Drug: Normal saline; Drug: 5% bupivacaine

• Registration Number: NCT03792009
• Lead Sponsor: Kangbuk Samsung Hospital

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 Timeline

• Study First Submitted: 2018-12-28
• Study First Submitted QC: 2018-12-31
• Study First Posted: 2019-01-03
• Status Verified: 2019-02
• Study Start: 2019-02-21
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-25
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracervical block with 5% bupivacaine	Paracervical block	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.
Paracervical block with normal saline	Paracervical block	The paracervical injection with 10 mL of normal saline 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.
Paracervical block with normal saline	Normal saline	The paracervical injection with 10 mL of normal saline 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.
Paracervical block with 5% bupivacaine	5% bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	at 6-hour after surgery	The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".

Secondary Outcome Measures

Name	Time	Method
Frequency of pills/injections requested	Within 24-hour after surgery	Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery.

Trial Locations

Locations (3)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of