Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201626031418 Date of Approval: 10/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between paracervical block anesthesia and Spinal anesthesia in women who will do dilatition and curettage for abnormal uterine bleeding
Official scientific title Comparison between paracervical block anesthesia and Spinal anesthesia regarding endometrial sampling in women with abnormal uterine bleeding
Brief summary describing the background and objectives of the trial The aim of this study was to compare the efficacy of paracervical block with intrauterine instillation of lidocaine, paracervical block, and a regional spinal anesthesia to control pain during dilatation and curettage in premenopausal and postmenopausal women who had abnormal uterine bleeding and will need DC biopsy. study objectives: 1- To determine the severity of the pain perceived by the patient in paracervical block anaethesia versus the spinal anesthesia in women with abnormal uterine bleeding. 2- To assess the complications associated with both procedures. 3- To obtain cervical and endometrial specimens from women with abnormal uterine bleeding for histopathological evaluation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied abnormal uterine bleeding
Purpose of the trial Early detection /Screening
Anticipated trial start date 17/05/2021
Actual trial start date 29/06/2021
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 20/12/2021
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 240
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
4567 ethics committee of Faculty of Medicine Suez canal university
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group paracervical block 10ml zilocine will be injected at once paracervical block with intrauterine instillation of lidocaine, paracervical block, and a regional spinal anesthesia to control pain during dilatation and curettage in premenopausal and postmenopausal women who had abnormal uterine bleeding and will need DC biopsy. 120
Control Group spinal anaethesia 10minutes Under complete aseptic conditions, the patient will assume a sitting position. After sterilization of the back, the correct space for injecting the agent will be identified. The intercristine line, the line joining the iliac crests of both sides, will be identified and the spinous process at this line will be the level of L4 lumbar vertebra. Then the interspace between L4 and L5 lumbar vertebrae will be marked. A hypodermic needle with lidocaine 2 % is then inserted into the skin in the midline to obtain analgesia between the fourth and fifth lumbar vertebral spines. A small cutaneous wheal should be raised over the surface of the skin during the process. A 25-gauge spinal needle will be introduced in the midline at the level of marked interspace with a 15 degree cephalad angulation with the patient in sitting position. Advance the needle till two ''pops'' are appreciated. The first is due to the penetration of ligamentum flavum, and the second pop results from the puncture of the dura-subarachnoid membrane. Confirm the successful dural puncture by withdrawing the stylet and observing spontaneous clear cerebrospinal fluid (CSF) leakage through the needle. Attach the syringe containing the anesthetic drug to the needle, aspirate the CSF to ensure the needle has not moved from its initial place. Inject the local anaesthetic slowly with the bevel of the spinal needle directed caudaly. The patient is instructed to keep sitting in the same position for five minutes after the injection of the drug. The patient is then placed in lithotomy position to start the endometrial sampling by dilatation and curettage. 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Age from 25-60 years with abnormal uterine bleeding 2- Patients with ultrasound findings of endometrial or cervical pathology which will require cervical and endometrial sampling. 3-Patients who were ASAI (American Society of Anesthesiologists') physical status Grade I, ASA II (ASA Grade II). 4-Controlled clinical illness as DM and hypertension. 5-No history of allergic reaction to the anaesthetic agents. 1-Patients with mental or behavioral disorders that will impair or interfere with perioperative and follow-up procedures, 2-Bleeding tendency, 3- patients with cervicitis or pelvic inflammatory disease before treatment. 4-A known sensitivity to used drugs, 5-Pregnancy, 6-vaginismus Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/05/2021 faculty of medicine Suez canal university
Ethics Committee Address
Street address City Postal code Country
eldairy ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome 1- To determine the severity of the pain perceived by the patient in paracervical block anaethesia versus the spinal anesthesia in women with abnormal uterine bleeding. 2- To assess the complications associated with both procedures. 3- To obtain cervical and endometrial specimens from women with abnormal uterine bleeding for histopathological evaluation. at time of operation
Primary Outcome To compare between paracervical block in pain control in dilation and curettage and the spinal anesthesia in women with abnormal uterine bleeding. an hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital eldairy street ismailia 41511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the principal investigator elgamaa elkadema street ismailia 41511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculity of medicine Suez canal university eldairy street ismailia 41522 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator heba mohammed dr_hebasaber83@hotmail.com 01118602920 elgamaa elkadema
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecture of obstetrics and gynecology faculty of medicine Suez canal university
Role Name Email Phone Street address
Public Enquiries magy refaat dr_magdygyna@yahoo.com 01061801323 elgamaa
City Postal code Country Position/Affiliation
ismailia 41522 Egypt professor of obstetrics and gynecology faculity of medicine suez canal university
Role Name Email Phone Street address
Scientific Enquiries omima tharwat omimatharwat@yahoo.com 01223423685 garden city street
City Postal code Country Position/Affiliation
ismailia 41522 Egypt assistant professor of obstetrics and gynacology faculity of medicine suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data sharing will be after approval of the research ethics committee and when required Study Protocol after study completion when required and after approval of the research ethics comittee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information