Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial

Kayseri Education and Research Hospital

Status: Completed

Conditions: Pain Score

Treatments: Drug: Paracervical block + lidocaine spray; Drug: Paracervical block; Drug: Lidocaine spray

Study type: Interventional

Funder types: Other

Identifiers

NCT02007408

KERH

Details and patient eligibility

About

Objective: The investigators sought to investigate the analgesic efficiency of lidocaine spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray combination in patients undergoing first-trimester surgical abortion.

Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108 women with the request of pregnancy termination.The subjects were randomly assigned into four groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard Visual Analog Scale (VAS).

Enrollment: 108 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Age >18 years Single Pregnancy <7 weeks of gestation

Exclusion criteria

Incomplete abortion Early pregnancy failure Acute cervicitis Untreated pelvic inflammatory disease Cervical stenosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 4 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Paracervical block plus lidocaine spray

Active Comparator group

Description:

Lidocaine injection+Lidocaine spray received PCB with 2 ampoules of lidocaine solution plus 2 pumps (20 mg=2 pumps) of 10% lidocaine spray

Treatment:

Drug: Paracervical block + lidocaine spray

paracervical block plus isotonic saline spray

Active Comparator group

Description:

2 ampoules of lidocaine solution (20 mg Lidocaine HCl+0.0125 mg epinephrine/ml) plus isotonic spray

Treatment:

Drug: Paracervical block

only lidocaine spray

Active Comparator group

Description:

paracervical block with saline solution plus 10% lidocaine spray

Treatment:

Drug: Lidocaine spray