BACKGROUND:Endometrial biopsy is a common procedure for the investigation of many gynecological disorders including abnormal uterine bleeding, postmenopausal bleeding, abnormal cytology and infertility. Most women experience some degree of discomfort and pain during the procedure. Pain may occur during dilation of the cervix for insertion of the catheter and during endometrial biopsy, which further aggravates pain by inducing uterine contraction. OBJECTIVES: To determine pain levels during endometrial biopsy by comparing intrauterine instillation of levobupivacaine or lidocaine with placebo in a randomized, double-blinded trial in pre- and postmenopausal women. METHODS:Ninety patients were allocated to either control or experimental groups before endometrial biopsy. The trial medication was intrauterine anesthesia, either 5 mL 0.9% saline (control group), or 5 mL 0.5% levobupivacaine or 2% lidocaine (experimental groups). Resident doctors used the same endometrial biopsy technique to minimize the risk of technical variation. All tissue specimens were sent for cytopathological examination. The pathologists, who were blinded to the study solution, analyzed all tissue specimens. The primary outcome measure was pain experienced during the procedure. Pain was assessed using a 10 cm visual analogue pain scale. All observed adverse effects were recorded until the patients were discharged. RESULTS:Pain scores of the intrauterine lidocaine and levobupivacaine groups were found to be significantly lower than the control group. There was no difference between the levobupivacaine and lidocaine groups with regard to pain scores. There was a moderately positive correlation between pain scores and endometrial thickness. No complications were observed due to the procedure. Most of the biopsy results were proliferative and secretory endometrium. Insufficient material causing inconclusive results was observed mostly in the control group. CONCLUSION: Transcervical intrauterine topical instillation of levobupivacaine or lidocaine causes pain relief during endometrial biopsy. However, further studies are needed to evaluate the effectiveness of intrauterine anesthesia, to determine optimal concentration, volume and waiting time according to the type of local anesthetic agent, and to assess the applicability of the method to other intrauterine procedures.
RCT Entities:
BACKGROUND: Endometrial biopsy is a common procedure for the investigation of many gynecological disorders including abnormal uterine bleeding, postmenopausal bleeding, abnormal cytology and infertility. Most women experience some degree of discomfort and pain during the procedure. Pain may occur during dilation of the cervix for insertion of the catheter and during endometrial biopsy, which further aggravates pain by inducing uterine contraction. OBJECTIVES: To determine pain levels during endometrial biopsy by comparing intrauterine instillation of levobupivacaine or lidocaine with placebo in a randomized, double-blinded trial in pre- and postmenopausal women. METHODS: Ninety patients were allocated to either control or experimental groups before endometrial biopsy. The trial medication was intrauterine anesthesia, either 5 mL 0.9% saline (control group), or 5 mL 0.5% levobupivacaine or 2% lidocaine (experimental groups). Resident doctors used the same endometrial biopsy technique to minimize the risk of technical variation. All tissue specimens were sent for cytopathological examination. The pathologists, who were blinded to the study solution, analyzed all tissue specimens. The primary outcome measure was pain experienced during the procedure. Pain was assessed using a 10 cm visual analogue pain scale. All observed adverse effects were recorded until the patients were discharged. RESULTS:Pain scores of the intrauterine lidocaine and levobupivacaine groups were found to be significantly lower than the control group. There was no difference between the levobupivacaine and lidocaine groups with regard to pain scores. There was a moderately positive correlation between pain scores and endometrial thickness. No complications were observed due to the procedure. Most of the biopsy results were proliferative and secretory endometrium. Insufficient material causing inconclusive results was observed mostly in the control group. CONCLUSION: Transcervical intrauterine topical instillation of levobupivacaine or lidocaine causes pain relief during endometrial biopsy. However, further studies are needed to evaluate the effectiveness of intrauterine anesthesia, to determine optimal concentration, volume and waiting time according to the type of local anesthetic agent, and to assess the applicability of the method to other intrauterine procedures.
Authors: Michael F Costello; Stephen Horrowitz; Stephen Steigrad; Najwa Saif; Michael Bennett; Abie Ekangaki Journal: Fertil Steril Date: 2002-11 Impact factor: 7.329