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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Idiopathic Pain Syndrome
• Intervention / Treatment: Drug: MARCAINE AND BETAMETHAZONE 1; Drug: MARCAINE AND BETAMETHAZONE 2

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: RAMY mahrose, A.PROF.; Phone Number: 01281431097; Email: ramy.ahmed@med.asu.edu.eg
• Study Contact Backup: Name: ramy mahrose, A.PROF.; Phone Number: 0128143197; Email: ramy.ahmed@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 20
    • Recruiting
    • AIN shams university
    • Contact: Ramy Mahrose; Phone Number: 01281431097; Email: Ramy.ahmed@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: MARCAINE AND BETAMETHAZONE 1; Laparoscopic Hypo gastric Neural Plexus Block
Active Comparator: 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.	Drug: MARCAINE AND BETAMETHAZONE 2; Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue score	Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10	before laparoscopy
Visual analogue score	Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10	4 hours after laparoscopy
Visual analogue score	Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10	12 hours after laparoscopy
Visual analogue score	Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10	24 hours after laparoscopy
Visual analogue score	Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10	48 hours after laparoscopy
Visual analogue score	Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10	1st week after laparoscopy
Visual analogue score	Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10	4th week after laparoscopy
Visual analogue score	Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10	8th week after laparoscopy
Visual analogue score	Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10	12th week after laparoscopy
Visual analogue score	Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10	16th week after laparoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
constipation(number of patients)	up to 16 weeks postoperatively
urinary retention (number of patients)	up to 16 weeks postoperatively
duration of pain relieve	up to 16 weeks postoperatively
Duration of pelvic pain relieve	up to 16 weeks postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: AIN SHAMS UNIVERSITY, asuh

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Anticipated): April 26, 2023
• Study Completion (Anticipated): April 26, 2023

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB00006379 ANESTHESIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No