An interventional study of Paracervical block and Intracervical in Abortion, Induced and Pain, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical block would produce lower pain scores than paracervical block at the time of cervical dilation.
University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Paracervical block · Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate
Procedure: Intracervical · Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate
The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.
The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.
The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)
VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain
Time frame: at completion of procedure
Gestational Age at Time of Procedure
Time frame: At the time of the procedure
| Milestone | Paracervical Block | Intracervical Block |
|---|---|---|
| Started | 45 | 44 |
| Completed | 45 | 44 |
| Not completed | 0 | 0 |
VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain
| units on a scale | Paracervical Block | Intracervical Block |
|---|---|---|
| Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS) | 4.25 ± 0.6 | 3.97 ± 0.5 |
| Days | Paracervical Block | Intracervical Block |
|---|---|---|
| Gestational Age at Time of Procedure | 51 ± 11 | 54 ± 9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paracervical Block | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Intracervical Block | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Age, Categorical(Participants) | Paracervical Block | Intracervical Block | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 44 | 89 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Paracervical Block | Intracervical Block | Total |
|---|---|---|---|
| Female | 45 | 44 | 89 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Diego