Chronic Idiopathic Pain SyndromeNCT05345782
Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain
A study testing MARCAINE AND BETAMETHAZONE 1 and MARCAINE AND BETAMETHAZONE 2 in people with Chronic Idiopathic Pain Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Idiopathic Pain Syndrome
- What is being tested?
- MARCAINE AND BETAMETHAZONE 1 and MARCAINE AND BETAMETHAZONE 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2022to 26 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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.
Who cannot join
- • Patient refusal.
- Patients on chronic pain medications.
- ASA III or worse clinical condition.
- Intra-abdominal infection.
- Allergy to any of the study medications.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo, 20
ramy mahrose, 01281431097, ramy.ahmed@med.asu.edu.eg
About this study
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
Read the 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
- Being tested
- MARCAINE AND BETAMETHAZONE 1, MARCAINE AND BETAMETHAZONE 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARCAINE AND BETAMETHAZONE 1Drug
Laparoscopic Hypo gastric Neural Plexus Block
MARCAINE AND BETAMETHAZONE 2Drug
Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Hypo gastric Neural Plexus Block | Active comparator | 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. Receives: Drug: MARCAINE AND BETAMETHAZONE 1 |
| Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block | Active comparator | 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. Receives: Drug: MARCAINE AND BETAMETHAZONE 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
Visual analogue scale:
No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Measured: before laparoscopy
Visual analogue score
Visual analogue scale:
No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 16th week after laparoscopy
Secondary outcomes (4)
constipation(number of patients)
Measured: up to 16 weeks postoperatively
urinary retention (number of patients)
Measured: up to 16 weeks postoperatively
duration of pain relieve
Measured: up to 16 weeks postoperatively
Duration of pelvic pain relieve
Measured: up to 16 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start20 Apr 2022
- Primary completion26 Apr 2023 (estimated)
- Study completion26 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
- Investigators
- AIN SHAMS UNIVERSITY, Study chair, asuh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345782
- Sponsor's protocol ID
- IRB00006379 ANESTHESIA
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05345782
- Acronym / sponsor ID
- IRB00006379 ANESTHESIA
- Conditions
- Chronic Idiopathic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 26 Apr 2023 (estimated)
- Study completion
- 26 Apr 2023 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Hypo gastric Neural Plexus Block | Active comparator | Drug: MARCAINE AND BETAMETHAZONE 1laparoscopy 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. |
| Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block | Active comparator | Drug: MARCAINE AND BETAMETHAZONE 2laparoscopy 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Age 18 to 50 years old.
Key exclusion criteria (5 listed)
- • Patient refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MARCAINE AND BETAMETHAZONE 1Laparoscopic Hypo gastric Neural Plexus Block | Drug | Laparoscopic Hypo gastric Neural Plexus Block |
| MARCAINE AND BETAMETHAZONE 2Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block | Drug | Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block |
Primary outcome
Visual analogue score
Time frame: before laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Time frame: 4 hours after laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Time frame: 12 hours after laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Time frame: 24 hours after laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Time frame: 48 hours after laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Time frame: 1st week after laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Time frame: 4th week after laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Time frame: 8th week after laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Time frame: 12th week after laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
Visual analogue score
Time frame: 16th week after laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
4 secondary outcomes
constipation(number of patients)
Time frame: up to 16 weeks postoperatively
urinary retention (number of patients)
Time frame: up to 16 weeks postoperatively
duration of pain relieve
Time frame: up to 16 weeks postoperatively
Duration of pelvic pain relieve
Time frame: up to 16 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AIN SHAMS UNIVERSITY study chair
asuh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MARCAINE AND BETAMETHAZONE 1 and MARCAINE AND BETAMETHAZONE 2 in people with Chronic Idiopathic Pain Syndrome, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RAMY mahrose, A.PROF. (01281431097, ramy.ahmed@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score (time frame: before laparoscopy). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.