Pain relief by various anaesthetic agent while doing endometrial biopsy

Completed

Conditions: Excessive and frequent menstruation with irregular cycle,

Registration Number: CTRI/2021/03/032320

Lead Sponsor: AIIMS Jodhpur

Brief Summary: TITLE : Assessment of efficacy of various Local Anaesthetic modalities on Pain Relief during Endometrial Biopsy: a randomized control trial

INTRODUCTION:

When it comes to OPD minor gynaecological procedures pain and anxiety management are important for successful procedure. Pain remains a limiting factor, despite of universal efforts to decrease discomfort during surgical procedures.

Endometrial sampling, cervical biopsy, sonosalpingography and office hysteroscopy are few of the minor office procedures done in gynaecology OPD. Endometrial suction curette biopsy, fractional curettage or hysteroscopic guided biopsy are done routinely as a part of evaluation of abnormal uterine bleeding in OPD because of increasing workload and the relative lack of time. 1 Patients usually tolerates the pain during these procedure but studies show that endometrial biopsies have shown VAS scores ranging from five to seven2,3,. If pain on VAS is more than six, then it suggests the need of pain relief.

Tenaculum application and sampling is major reason for pain in OPD based endometrial biopsy despite all its advantages. It is seen that at times severity of pain makes it impossible to take adequate sample in biopsy. Various methods to prevent pain are use of nonsteroidal anti-inflammatory drugs before procedure, application of anaesthetic gels to cervix, and local anaesthetic before the procedure. A clear outcome regarding the benefit of these pre-procedural treatments is still awaited.4

The paracervical block is one of the most common local anaesthesia used since 1925 5. Paracervical block is a convenient, safe, simple, and effective anaesthetic technique for curettage being used by most clinician2. It is given in nerve fibres at the level of internal os thus blocks transmission of pain through sympathetic and parasympathetic sensory fibres,

This study is aimed to establish pain control protocol during office endometrial biopsy.

SPECIFIC OBJECTIVES:

a. To assess a suitable and effective method of analgesia during the endometrial biopsy,

b. comparing VAS score of patients by using 3 different pain control modalities.

HYPOTHESIS: Lignocaine gel is equally effective local anaesthesia as paracervical block and lignocaine spray.

STUDY DESIGN: Randomised control single-centre study.

STUDY PERIOD: ONE YEAR

STUDY POPULATION: Females undergoing endometrial biopsy in AIIMS Gyanecology OPD.

Inclusion criteria:

Patients who presented with abnormal vaginal bleeding at the gynecology outpatients department between the specified period and were planned for endometrial biopsy, who can understand language, and willing to participate in study.

Exclusion criteria:

1.pregnancy,

2.women with an active vaginal infection

3.women with heart disease,

4.female using an intrauterine device, and

5. those who underwent cervical polypectomy during procedure

6.were allergic to lidocaine,

7.had known cases of abnormal uterine structure

8.Patients who had a history of abnormal coagulopathy were currently taking medication affecting coagulation

METHODOLOGY:

After taking Informed consent, a total of 120 women scheduled for endometrial curettage would be divided into three groups with a simple randomization technique. Patients in Group 1 (n=40) will receive paracervical block while in Group 2 (n=40) 2% lidocaine gel will be applied on ectocervix and into cervical canal and patients in Group 3 (n=40) would receive nothing for pain control prior to endometrial sampling.

A bimanual vaginal examination will be done in lithotomy position. The cervix would be exposed by placing a speculum and vagina will be cleaned with 10% povidon-iodine. In group 1, the paracervical block will be performed by using 5ml of 1% lidocaine. It would be injected at the 3 and 9 oâ€™clock positions of the cervicovaginal reflection at âˆ¼1 cm depth with the help of 5cc syringe. In group 2, 2% lidocaine gel(1cc) would be applied on the ectocervix, 3 min before the application of tenaculum; simultaneously 2 cc gel is instilled into cervical canal with the help of 2cc syringe without needle. In group 3 patient, nothing will be applied on the cervical surface 3 minutes before starting the procedure. The biopsy would be performed with the Novaks endometrial curette. Gynaecologist will explain the visual analogue scale (pain decreased as getting close to 0 on the left and increased as getting close to 10 on the right) to the patient and current pain status will be determined on the scale. Scoring will be done during the procedure (T1), 10 min after the procedure (T2) and 1hr after the procedure(T3). Vasovagal symptoms, bradycardia, hypotension, fatigue, sweating, nausea, and vomiting will be evaluated concurrently.

PRIMARY OUTCOME MEASURE:

1.To compare efficacy of various pain control modalities during endometrial biopsy

SECONDARY OUTCOME MEASURE:

1. Assessment of pain score during endometrial biopsy.

Data analysis plan

The Pearson chi-square test and Fisher exact test were used to compare pain score in three groups. The Student t-test was used to analyse the demographic data. P value less than 0.05 was considered significant.

REFERENCES:

1.Aashima A, Ajitabh S, Subhas SC. Effectiveness of intrauterine lignocaine in addition to paracervical block for pain relief during dilatation and curettage, and fractional curettage. J Obstet Gynecol India 2016; 66:174â€“179.

2.Mittal P, Goyal M. Pain relief during minor procedures: a challenge for gynaecologists. Indian J Med Res. 2015 Oct;142(4):366-8. doi: 10.4103/0971-5916.169192.

3.Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, et al. OARSI recommendations for the management of hip and knee osteoarthritis. Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16:137â€“62.

4.Ibrahim Karaca,1 Omer Erkan Yapca,2 Mehmet Adiyeke,3 Emrah Toz,4 and Suna Yildirim Karaca Effect of Cervical Lidocaine Gel for Pain Relief in Pipelle Endometrial Sampling. Eurasian J Med. 2016 Oct; 48(3): 189â€“191;doi: 10.5152/eurasianjmed.2016.0068

5. Tangsiriwatthana T, Sangkomkamhang US, Lumbiganon P, Laopaiboon M. Paracervical local anaesthesia for cervical dilatation and uterine intervention. Cochrane Database Syst Rev. 2013 Sep 30;9:CD005056

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 120

Inclusion Criteria

Patients who presented with abnormal vaginal bleeding at the gynecology outpatients department.

Exclusion Criteria

1.pregnancy, 2.women with an active vaginal infection 3.women with heart disease, 4.female using an intrauterine device, and 5.
those who underwent cervical polypectomy during procedure 6.were allergic to lidocaine, 7.had known cases of abnormal uterine structure 8.Patients who had a history of abnormal coagulopathy were currently taking medication affecting coagulation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare efficacy of various pain control modalities during endometrial biopsy	During and after procedure

Secondary Outcome Measures

Name	Time	Method
Assessment of pain score during endometrial biopsy.	During and after procedure

Trial Locations

Locations (1): OPD, Department of Obs and gynae, AIIMS Jodhpur, RAJASTHAN
🇮🇳
Jodhpur, RAJASTHAN, India
OPD, Department of Obs and gynae, AIIMS Jodhpur, RAJASTHAN
🇮🇳Jodhpur, RAJASTHAN, India
Neha Agrawal
Principal investigator
9479728525
dr.nehaagrawal08@gmail.com