Mari Kiviharju1, Ilkka Kalliala, Pekka Nieminen, Tadeusz Dyba, Annika Riska, Maija Jakobsson. 1. 1Obstetrics and Gynecology, University of Helsinki and University Central Hospital, Helsinki, Finland, and 2 Public Health - Cancer Policy Support, Institute for Health and Consumer Protection, European Commission, DG Joint Research Centre, Ispara, Italy.
Abstract
OBJECTIVE: The aim of the study was to determine whether an injection of a local anesthetic is more painful than a cervical punch biopsy without local anesthesia. MATERIALS AND METHODS: The study was a randomized controlled trial, conducted at the Helsinki University Central Hospital. It consisted of 204 women referred for colposcopic assessments. Half of them were randomized to receive local anesthesia before their cervical punch biopsies. After the injection of the local anesthetic, the cervical punch biopsy, and the endocervical curettage, the women scored their actual pain using a 10-cm visual analog scale (VAS).To measure the difference in VAS scores between two groups, a linear regression model was used. Binomial regression model was applied for comparing the probability of experiencing unbearable pain between the groups. Applying modeling approach allowed also for proper adjustment for other potential risk factors. RESULTS: The mean VAS score for the injection of the local anesthetic was 2.7, the VAS score for the cervical punch biopsy without local anesthesia was 3.5, and the difference was 0.8 (p = .017; 95% CI = 0.1-1.5). The mean VAS for the biopsy with local anesthesia was 0.8, which was significantly lower than the mean VAS for the biopsy without local anesthesia (difference = 2.7; p < .001; 95% CI = 2.2-3.3). The relative risk for experiencing moderate or severe pain (VAS ≥ 5) was 0.6 (p = .03; 95% CI = 0.3-0.9) for the injection of local anesthetic versus the biopsy without local anesthesia. CONCLUSIONS: Injection of a local anesthetic for colposcopy is less painful than biopsies without local anesthesia, and local anesthesia decreases the pain perceived.
RCT Entities:
OBJECTIVE: The aim of the study was to determine whether an injection of a local anesthetic is more painful than a cervical punch biopsy without local anesthesia. MATERIALS AND METHODS: The study was a randomized controlled trial, conducted at the Helsinki University Central Hospital. It consisted of 204 women referred for colposcopic assessments. Half of them were randomized to receive local anesthesia before their cervical punch biopsies. After the injection of the local anesthetic, the cervical punch biopsy, and the endocervical curettage, the women scored their actual pain using a 10-cm visual analog scale (VAS).To measure the difference in VAS scores between two groups, a linear regression model was used. Binomial regression model was applied for comparing the probability of experiencing unbearable pain between the groups. Applying modeling approach allowed also for proper adjustment for other potential risk factors. RESULTS: The mean VAS score for the injection of the local anesthetic was 2.7, the VAS score for the cervical punch biopsy without local anesthesia was 3.5, and the difference was 0.8 (p = .017; 95% CI = 0.1-1.5). The mean VAS for the biopsy with local anesthesia was 0.8, which was significantly lower than the mean VAS for the biopsy without local anesthesia (difference = 2.7; p < .001; 95% CI = 2.2-3.3). The relative risk for experiencing moderate or severe pain (VAS ≥ 5) was 0.6 (p = .03; 95% CI = 0.3-0.9) for the injection of local anesthetic versus the biopsy without local anesthesia. CONCLUSIONS: Injection of a local anesthetic for colposcopy is less painful than biopsies without local anesthesia, and local anesthesia decreases the pain perceived.