Clinical trial · Interventional
Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)
NCT04068766CI-TRIAL-00040263PALMunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in laparoscopic myomectomy (LM), 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 LM for benign gynecologic conditions on postoperative pain relief.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5% bupivacaine | Drug | — | UNRESOLVED |
| Normal saline | Drug | — | UNRESOLVED |
| Paracervical block | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Device: Paracervical block
- Drug: 5% bupivacaine
- type
- PLACEBO_COMPARATOR
- label
- Paracervical block with normal saline
- description
- ck with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
- interventionNames
- Device: Paracervical block
- Drug: Normal saline
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Uterine myoma * 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 procedure (anterior or posterior colporrhaphy or mid-urethral slings) * previously taking opioids for chronic pain * inability to accurately express their pain
References
Publications (0)
Data not yet available
No reference posted for this study.