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Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain

Primary Purpose

Chronic Idiopathic Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
MARCAINE AND BETAMETHAZONE 1
MARCAINE AND BETAMETHAZONE 2
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Pain Syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Age 18 to 50 years old.

    • American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.
    • Sex: female.
    • Patients scheduled for elective laparoscopy for diagnosis of the cause of chronic pelvic pain.

Exclusion Criteria:

  • • Patient refusal.

    • Patients on chronic pain medications.
    • ASA III or worse clinical condition.
    • Intra-abdominal infection.
    • Allergy to any of the study medications.

Sites / Locations

  • Ain shams universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopic Hypo gastric Neural Plexus Block

Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block

Arm Description

laparoscopy for diagnosis of the causes of chronic pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the sacral promontory then30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) are injected.

laparoscopy for diagnosis and conventional surgical treatment of the causes of pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the promontory followed by 30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) then injecting 5 ml ( 2.5 marcaine+1ml betamethasone +1.5 ml normal saline) 2 cm away from the cervix at the uterosacral ligament on each sides.

Outcomes

Primary Outcome Measures

Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10

Secondary Outcome Measures

constipation(number of patients)
urinary retention (number of patients)
duration of pain relieve
Duration of pelvic pain relieve

Full Information

First Posted
March 24, 2022
Last Updated
April 4, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05345782
Brief Title
Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain
Official Title
Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
April 26, 2023 (Anticipated)
Study Completion Date
April 26, 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
Often the etiology of chronic pelvic pain is not clear, as there are many disorders of the reproductive tract, gastrointestinal system, urological organs, musculoskeletal system, and psych neurological system that may be associated with chronic pelvic pain. An effective treatment for this condition has evaded the medical profession for centuries. Even today only 20-25% patients respond to conservative management.5 When such treatment fails, a diagnostic laparoscopy is performed.1, 3, 6 the cause of the pain is not always obvious as no pathology is seen in 40-60% of the cases.1
Detailed Description
This prospective randomized controlled study will be conducted at Eldemerdash hospital. 60 patients will be included with the following criteria: . Intraoperatively, all patients were monitored by standard monitoring. All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (thirty patients per group): Group A ; thirty patients will do laparoscopy for diagnosis of the causes of chronic pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the sacral promontory then30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) are injected. Group B; thirty patients will do laparoscopy for diagnosis and conventional surgical treatment of the causes of pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the promontory followed by 30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) then injecting 5 ml ( 2.5 marcaine+1ml betamethasone +1.5 ml normal saline) 2 cm away from the cervix at the uterosacral ligament on each sides. Pain score ( visual analogue score) was assessed before surgery (basal) and after completion of laparoscopy 4hr, 12hr, 24hr, 48hr, 1, 4, 8,12, 16,20 and 24 weeks. Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10 Duration of pelvic pain relieve after laparoscopy up to 16 weeks,side effects like urinary retention, constipation were recorded after completion of laparoscopy 4hr, 12hr, 24hr, 48hr, 1week, 4weeks, 8 weeks, 12 weeks and 16 weeks. Urinary retention will be treated by reassuring the patients and catheterization as it usually resolves after 2-3 days, constipation will be treated by reassuring the patients and purgatives as it usually resolves after 2-3 days. Postoperatively, all patients were transferred to postoperative care unit (PACU) and monitored every 10 min until discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic Hypo gastric Neural Plexus Block
Arm Type
Active Comparator
Arm Description
laparoscopy for diagnosis of the causes of chronic pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the sacral promontory then30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) are injected.
Arm Title
Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block
Arm Type
Active Comparator
Arm Description
laparoscopy for diagnosis and conventional surgical treatment of the causes of pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the promontory followed by 30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) then injecting 5 ml ( 2.5 marcaine+1ml betamethasone +1.5 ml normal saline) 2 cm away from the cervix at the uterosacral ligament on each sides.
Intervention Type
Drug
Intervention Name(s)
MARCAINE AND BETAMETHAZONE 1
Intervention Description
Laparoscopic Hypo gastric Neural Plexus Block
Intervention Type
Drug
Intervention Name(s)
MARCAINE AND BETAMETHAZONE 2
Intervention Description
Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block
Primary Outcome Measure Information:
Title
Visual analogue score
Description
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time Frame
before laparoscopy
Title
Visual analogue score
Description
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time Frame
4 hours after laparoscopy
Title
Visual analogue score
Description
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time Frame
12 hours after laparoscopy
Title
Visual analogue score
Description
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time Frame
24 hours after laparoscopy
Title
Visual analogue score
Description
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time Frame
48 hours after laparoscopy
Title
Visual analogue score
Description
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time Frame
1st week after laparoscopy
Title
Visual analogue score
Description
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time Frame
4th week after laparoscopy
Title
Visual analogue score
Description
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time Frame
8th week after laparoscopy
Title
Visual analogue score
Description
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time Frame
12th week after laparoscopy
Title
Visual analogue score
Description
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Time Frame
16th week after laparoscopy
Secondary Outcome Measure Information:
Title
constipation(number of patients)
Time Frame
up to 16 weeks postoperatively
Title
urinary retention (number of patients)
Time Frame
up to 16 weeks postoperatively
Title
duration of pain relieve
Time Frame
up to 16 weeks postoperatively
Title
Duration of pelvic pain relieve
Time Frame
up to 16 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Age 18 to 50 years old. American Society of Anesthesiologists physical status (ASA-PS) I and II Patients. Sex: female. Patients scheduled for elective laparoscopy for diagnosis of the cause of chronic pelvic pain. Exclusion Criteria: • Patient refusal. Patients on chronic pain medications. ASA III or worse clinical condition. Intra-abdominal infection. Allergy to any of the study medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RAMY mahrose, A.PROF.
Phone
01281431097
Email
ramy.ahmed@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ramy mahrose, A.PROF.
Phone
0128143197
Email
ramy.ahmed@med.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AIN SHAMS UNIVERSITY
Organizational Affiliation
asuh
Official's Role
Study Chair
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
20
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ramy mahrose
Phone
01281431097
Email
ramy.ahmed@med.asu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain

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