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the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy

Primary Purpose

Gynecology

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy.
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gynecology

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women undergoing elective total laparoscopic hysterectomy Body mass index less than 29 Kg/m2 Exclusion Criteria: 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)

Sites / Locations

  • Ain Shams universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

pre-sacral nerve block

Arm Description

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

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.

Outcomes

Primary Outcome Measures

● 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

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
March 14, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05757011
Brief Title
the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy
Official Title
the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy: a Triple Blind Placebo Controlled RCT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
July 10, 2023 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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 , then the uterus will be removed, and the operation will be terminated While patients randomized to group B will undergo TLH with pre-sacral nerve block as follows: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
pre-sacral nerve block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy.
Intervention Description
pre-sacral nerve block (bupivacaine injection into both uterosacral ligaments at the end of laparoscopic hysterectomy.
Primary Outcome Measure Information:
Title
● 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
Description
● 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
Time Frame
1hour

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women undergoing elective total laparoscopic hysterectomy Body mass index less than 29 Kg/m2 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rana M Wagdy, Lecturer
Phone
01011431780
Email
Ranawagdy5@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gihan Elhawary, Professor
Phone
01146666794
Email
dr.asmaa.r.mady@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gasser Elbishry, Professor
Organizational Affiliation
Ain Shams Maternity Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams university
City
Cairo
ZIP/Postal Code
11511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa Mady
Phone
01011431780

12. IPD Sharing Statement

Plan to Share IPD
No

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the Effect of Pre-sacral Nerve Block on Post-operative Pain Following Laparoscopic Hysterectomy

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