NCT05757011

Brief Summary

40 patients who are consenting to be recruited in the study and are fulfilling the eligibility criteria will be subjected to: Group A Before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22G needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, FIPCO, Egypt)will be administered. While patients randomized to group B will undergo TLH with pre-sacral nerve block.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

3.5 years

First QC Date

February 20, 2023

Last Update Submit

March 14, 2023

Conditions

Gynecology

Outcome Measures

Primary Outcomes (1)

  • ● Post-operative pain 1 hour after the procedure will be assessed by visual analogue scale (VAS). (range will be from zero (no pain) to 10

    ● Post-operative pain 1 hour after the procedure will be assessed by visual analogue scale (VAS). (range will be from zero (no pain) to 10

    1hour

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Before the removal of uterus and the closure of vaginal cuff, insertion of 6inch 22G needle 2 to 3 cm below the umbilicus, 30 ml normal saline (sodium chloride solution 0.9%, FIPCO, Egypt)will be administered , then the uterus will be removed, and the operation will be terminated

Procedure: pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy.

pre-sacral nerve block

EXPERIMENTAL

Uterosacral nerve block will be performed before the removal of uterus and the closure of vaginal cuff, and before the removal of trocars from abdominal cavity, insertion of 6-inch 22G needle 2 to 3 cm below the umbilicus, injection of the SHP area which situated anterior to L5-S1 vertebral bodies, Caudal to the bifurcation of the abdominal aorta with 30 ml 0.25% bupivacaine (Marcaine®0.25% , Astra Zeneca, Egypt) will be administered. Following the injection of local anesthetic, patient will be placed from Trendelenburg position to horizontal position. The we will remove the uterus and trocars , and the operation will be terminated. Data will be recorded in a case report form (CRF) and statistical analysis will be done.

Procedure: pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy.

Interventions

pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy.PROCEDURE

pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy.

Placebopre-sacral nerve block

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women undergoing elective total laparoscopic hysterectomy Body mass index less than 29 Kg/m2

You may not qualify if:

  • Previous presacral neurectomy
  • Concurrent surgical procedure other than salpingectomy and/or oophorectomy
  • Chronic narcotic consumption Inability to provide consent
  • Patients with contraindication to laparoscopic surgery (e.g. severe cardiopulmonary dysfunction).
  • Bleeding tendency (e.g. patient on anticoagulants, platelets disorders)
  • Intra-abdominal adhesions (due to previous abdominal surgery e.g. myomectomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university

Cairo, 11511, Egypt

RECRUITING

Study Officials

  • Gasser Elbishry, Professor

    Ain Shams Maternity Hospital

    STUDY CHAIR

Central Study Contacts

Rana M Wagdy, Lecturer

CONTACT

01011431780Ranawagdy5@gmail.com

Gihan Elhawary, Professor

CONTACT

01146666794dr.asmaa.r.mady@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 7, 2023

Study Start

January 5, 2020

Primary Completion

July 10, 2023

Study Completion

August 10, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)