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

NCT ID: NCT05345782

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2023-04-26

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.

Conditions

Chronic Idiopathic Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Laparoscopic Hypo gastric Neural Plexus Block

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 Type: ACTIVE_COMPARATOR

MARCAINE AND BETAMETHAZONE 1

Intervention Type: DRUG

Laparoscopic Hypo gastric Neural Plexus Block

Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block

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.

Group Type: ACTIVE_COMPARATOR

MARCAINE AND BETAMETHAZONE 2

Intervention Type: DRUG

Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block

Interventions

MARCAINE AND BETAMETHAZONE 1

Laparoscopic Hypo gastric Neural Plexus Block

Intervention Type: DRUG

MARCAINE AND BETAMETHAZONE 2

Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

RAMY AHMED

ASSITANT PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AIN SHAMS UNIVERSITY

Role: STUDY_CHAIR

asuh

Locations

Ain shams university

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

RAMY mahrose, A.PROF.

Role: CONTACT

ramy.ahmed@med.asu.edu.eg

01281431097

ramy mahrose, A.PROF.

Role: CONTACT

ramy.ahmed@med.asu.edu.eg

0128143197

Facility Contacts

ramy mahrose

Role: primary

ramy.ahmed@med.asu.edu.eg

01281431097

Other Identifiers

IRB00006379 ANESTHESIA

Identifier Type: -

Identifier Source: org_study_id