Effectiveness of Paracervical Block in Endometrial Sampling Procedures for Pain Control
Condition: Office-based Endometrial Sampling Procedures
Study type: Interventional

Summary: 
      Office-based endometrial procedures are preferred over diagnostic dilation and curettage,
      nowadays. Paracervical block is single-shot nerve block that involve a one-time injection of
      local anesthetic adjacent to the utero-vaginal nerve plexus. Block provides analgesia during
      cervical pass of sampling device or manipulation of cervix. The paracervical block seems to
      work within few minutes after injection, but the optimal waiting time between injection and
      procedure is not known. In this randomized controlled study, it was aimed to determine the
      effect of waiting time of 1 minute and 3 minutes after paracervical block in endometrial
      sampling procedures using Pipelle cannula in terms of pain during and after the endometrial
      sampling and to compare with NSAIDs taken before the procedure.
    

Detailed description: 
      120 participants who will undergo endometrial biopsy due to abnormal uterine bleeding will be
      enrolled in the study. The research will be conducted in 4 branches. These branches are Group
      1: Waiting 1 Minute After Paracervical Block, Group 2: Waiting 3 Minute After Paracervical
      Block, Group 3: Control Group and Group 4: Waiting 60 Minute After Taking Oral NSAIDs. Thirty
      patients will be included in each group using power analysis of clinical studies in which
      endometrial biopsy techniques and pain comparisons were performed before [Mody SK, Farala JP,
      Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among
      Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018;132(3):575-582.].

      Pregnancy, pelvic infections, heavy bleeding disorders and NSAID allergy are the exclusion
      criteria.

      In the study, the success of analgesic methods to be used for endometrial biopsy during and
      30 minutes after the procedure will be compared. These methods include waiting 1 minute after
      the paracervical block is performed, waiting 3 minutes after the paracervical block is
      performed, and taking oral NSAIDs one hour before the procedure. All arms will be included 30
      participants and control group with 30 participants is formed. The Numeric Pain Rating Scale
      (NPRS) system will be used for each case for pain during the procedure and 30 minutes after
      the procedure. According to this system, the fact that the participant have no pain will be
      evaluated as "0" point and having the most severe pain she can experience is "10" points.

      Before procedure the cervix and vaginal vault will be prepared with povidone iodine. A
      vaginal speculum will be used for optimal exposure and manipulation of cervix. All procedures
      will be performed without grasping the cervix with a tenaculum. Two-point (at 4 and 8 o'clock
      only) technique will be used for paracervical block for Group 1: Waiting 1 Minute After
      Paracervical Block and Group 2: Waiting 3 Minute After Paracervical Block. For these groups
      10 ml 2% Prilocaine (VEM İlac, Tekirdag, Turkey) will be injected for each side approximately
      10 mm into the cervical stroma at the cervico-vaginal junction with a 22- gauge hypodermic
      needle. The capped needle model will be employed for Group 3: Control Group. After cervical
      and vaginal preparation with povidone iodine a capped needle will be touched the
      cervico-vaginal junction at 4 and 8 o'clock. 550 mg Naproxen Sodium (Abdi Ibrahim, Turkey)
      will be given to participants in the Group 4, 60 minutes before the procedure.

      For all procedures, low pressure sampling device (Pipelle Cannula, Medbar Medical Equipment
      Inc.)will be inserted to the cavity and endometrial samples will be obtained using a
      corkscrew rotation combined with a repeating cephalic-caudal motion. The procedure will be
      repeated twice in each case to ensure standardization. All endometrial biopsies will be
      performed by the same operator.

      NPRS system will be explained to all groups after the procedure and the pain during the
      procedure will be requested to be graded. Thirty minutes after the procedure, the
      participants will be asked to rate current pain according to the NPRS system.

      The study was approved by institutional ethics committee. Written informed consent will be
      obtained from all participants.
    

Intervention name(s): Paracervical Block; 550 mg Naproxen Sodium 60 minutes before the procedure; The capped needle
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): Two-point (at 4 and 8 o'clock only) technique will be used for paracervical block for Group 1: Waiting 1 Minute After Paracervical Block and Group 2: Waiting 3 Minute After Paracervical Block. For these groups 10 ml 2% Prilocaine (VEM İlac, Tekirdag, Turkey) will be injected for each side approximately 10 mm into the cervical stroma at the cervico-vaginal junction with a 22- gauge hypodermic needle.; 550 mg Naproxen Sodium (Abdi Ibrahim, Turkey) will be given to participants in the Group 4, 60 minutes before the procedure.; The capped needle model will be employed for Group 3: Control Group. After cervical and vaginal preparation with povidone iodine a capped needle will be touched the cervico-vaginal junction at 4 and 8 o'clock.
Other intervention name(s): 550 mg Naproxen Sodium 60 minutes before the procedure.
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment