Paracervical Block in Laparoscopic Hysterectomy (PALAPA)

K

Kangbuk Samsung Hospital

Status

Unknown

Conditions

Uterine Fibroid
Adenomyosis

Treatments

Device: Paracervical block
Drug: 5% bupivacaine
Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03792009
2019-01-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

86 participants in 2 patient groups, including a placebo group

Paracervical block with 5% bupivacaine
Experimental group
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.
Treatment:
Drug: 5% bupivacaine
Device: Paracervical block
Paracervical block with normal saline
Placebo Comparator group
Description:
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.
Treatment:
Drug: Normal saline
Device: Paracervical block

Trial contacts and locations

3

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Central trial contact

Taejong Song, M.D., Ph.D.; Su Yaen Kim, M.D.

Data sourced from clinicaltrials.gov

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