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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05345782
Enrollment
60
Registered
2022-04-26
Start date
2022-04-20
Completion date
2023-04-26
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Idiopathic Pain Syndrome

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.

Interventions

DRUGMARCAINE AND BETAMETHAZONE 1

Laparoscopic Hypo gastric Neural Plexus Block

DRUGMARCAINE AND BETAMETHAZONE 2

Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
constipation(number of patients)up to 16 weeks postoperatively
urinary retention (number of patients)up to 16 weeks postoperatively
duration of pain relieveup to 16 weeks postoperatively
Duration of pelvic pain relieveup to 16 weeks postoperatively

Countries

Egypt

Contacts

Primary ContactRAMY mahrose, A.PROF.
ramy.ahmed@med.asu.edu.eg01281431097
Backup Contactramy mahrose, A.PROF.
ramy.ahmed@med.asu.edu.eg0128143197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026