Paracervical Block in Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Uterine Fibroid, Adenomyosis

Intervention / Treatment
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* Device: Paracervical block
* Drug: 5% bupivacaine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracervical block with 5% bupivacaine<br>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. | Device: Paracervical block<br>* The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine or 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.<br>* Other names: Control arm;Drug: 5% bupivacaine<br>* 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.<br>* Other names: Experimental arm;|
| Placebo Comparator: Paracervical block with normal saline<br>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. | Device: Paracervical block<br>* The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine or 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.<br>* Other names: Control arm;Drug: Normal saline<br>* 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.<br>* Other names: Control arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | The scale was presented as a 10-cm line with verbal descriptors ranging from no pain to worst imaginable pain. | at 6-hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of pills/injections requested | Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery. | Within 24-hour after surgery |