Pain, PhantomPhase 4NCT03694639
CT-guided Ganglion Impar Block for Management of Phantom Rectal Pain Syndrome
A Phase 4 study testing ganglion impar block in people with Pain, Phantom, run by Mansoura University at 1 site in Egypt.
Trial summary
Background:Patients underwent abdominoperineal resection with colostomy may suffered from phantom rectum pain syndrome in the perineal area.In this study, the investigators evaluate the combination between ganglion impar block to pregabaline in the treatment of phantom rectal pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Phantom
- What is being tested?
- ganglion impar block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jun 2018to 29 Jul 2019
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- complained from phantom rectal pain syndrome after abdominoperineal surgery for rectal cancer with colostomy.
Who cannot join
- those who refused to share
- evidence of local infection at the puncture site
- allergy to drugs used
- patients with bleeding tendency or coagulopathy, renal or hepatic failure, cardiac patients,
- bony abnormality and local malignant recurrence or lower vertebral metastasis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Yahay wahba
Al Mansurah
yahya Mohamed Wahba, MD, 01211313554, yahyawahba@ymail.com
About this study
Background:Patients underwent abdominoperineal resection with colostomy may suffered from phantom rectum pain syndrome in the perineal area.In this study, the investigators evaluate the combination between ganglion impar block to pregabaline in the treatment of phantom rectal pain syndrome.
Method: Forty patients were randomly allocated into 2 groups: Group A (n=20) where patients received pregabaline 150 mg twice daily. Group B (n=20) where patients received pregabaline 150 mg twice daily plus ganglion impar block using 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone.
Read the detailed description
Introduction:
Phantom pain syndromes are mostly recorded after amputation of limbs, but it may affect any part of the body (visceral or somatic) has sensory perception following its removal as breast, teeth or rectum.
Patients underwent abdominoperineal resection with colostomy may suffered from phantom rectum pain syndrome in the perineal area characterized as pins, needles, stinging, and burning occurring mostly in sitting positions.
phantom rectum pain syndrome is rarely reported and it is varies from individual to individual. The presence of preoperative rectal pain has a good correlation for the development of postoperative phantom pain.
The pathophysiological mechanisms of phantom phenomena is still unknown but it is neuropathic in nature and believed that it is initiated by changes arising at the peripheral, spinal and supraspinal level leading to central reorganization in additional to the psychogenic factor.
Ganglion impar is a sympathetic ganglion used to manage acute or chronic perineal pain, situated directly in front of the coccyx around the sacrococcygeal joint and behind the rectum in the retroperitoneal space. It can be reached by any guidance as fluoroscopy, computerized tomography, or ultrasound.
Ganglion impar can be done by using multiple methods such as of local anesthetics with steroids or neurolysis by phenol, alcohol and radiofrequency.
The proposal of this study: Is to find the efficacy of the ganglion impar block in patients suffering from phantom rectal pain syndrome after abdominoperineal surgery for rectal cancer with colostomy.
Aim of the work:
To evaluate the combination between ganglion impar block to pregabaline in the treatment of phantom rectal pain syndrome.
Hypothesis:
Management of phantom rectal pain syndrome is a challenging issue needing more appropriate method to reach the best result.
Recharge Gap:
there is a no researches discuss this issue and how to manage it in best way.
Patients and methods:
Study design and participants This randomized pilot controlled study was conducted in pain clinic, Oncology Hospital, Mansoura University during the period from June 2018 till December 2018. The study was accepted by the institutional research board(R.18.09.288 ) . Written informed consents were obtained from forty patients aged from 18 to 70 years of either sex complained from phantom rectal pain syndrome after abdominoperineal surgery for rectal cancer with colostomy.
Patient exclusion criteria include: those who refused to share, evidence of local infection at the puncture site, allergy to drugs used, patients with bleeding tendency or coagulopathy, renal or hepatic failure, cardiac patients, bony abnormality and local malignant recurrence or lower vertebral metastasis.
Routine investigations as complete blood count, coagulation profile (partial thromboplastin time (PTT), prothrombin activity and international normalized ratio (INR)), liver and renal function tests were done prior to procedure. All patients were learned and assessed by numerical rating scale (NRS) for the intensity of pain (If no pain the score was equal zero, if it is worst pain imaginable the score was equal 10).
Sample size:
Internal pilot sample size was estimated on 8 patients during the following period using G-power analysis , assuming α (type I error)=0.05 and β (type II error)= 0.2 (power= 80%) calculate a total sample size of 40.
Patients were randomly allocated into 2 groups:
Group A (n=20) where patients received pregabaline 150 mg twice daily. Group B (n=20) where patients received pregabaline 150 mg twice daily plus ganglion impar block using 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone.
Technique:
Patients were placed in prone position with a cushion under their lower abdomen. CT sections were done in the axial plane 4 mm slice thickness to detect the site of sacrococcygeal disk. After a suitable section was confirmed, two distances were measured, one from patient's spine to the proper site of entry and the other from the site of entry to the target point. Also the angle of needle entrance was calculated. The skin was marked and cleaned with an aseptic solution then anesthetized by 2 ml lidocaine 2%. 22 gauge spinal needle 12 cm was introduced until reach anterior to sacrococcygeal disk. When the needle tip location was ideal, 2 ml lidocaine mixed with1ml of radiopaque dye was injected. CT sagittal section was done to verify the retroperitoneal distribution of the dye. After good contrast spread confirmation, 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone was injected. The patients were observed for one hour after block to note any complication and were discharged at the same day.
- Conditions
- Pain, Phantom
- Being tested
- ganglion impar block
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ganglion impar blockOther
CT sections were done in the axial plane 4 mm slice thickness to detect the site of sacrococcygeal disk. After a suitable section was confirmed, two distances were measured, one from patient's spine to the proper site of entry and the other from the site of entry to the target point.22 gauge spinal needle 12 cm was introduced until reach anterior to sacrococcygeal disk. When the needle tip location was ideal, 2 ml lidocaine mixed with1ml of radiopaque dye was injected. CT sagittal section was done to verify the retroperitoneal distribution of the dye. After good contrast spread confirmation, 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone was injected
| Study group | Role | What they receive |
|---|---|---|
| Pregabaline group | No intervention | where patients received pregabaline 150 mg twice daily. |
| Pregabaline plus ganglion impar block group | Active comparator | where patients received pregabaline 150 mg twice daily plus ganglion impar block using 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone. Receives: Other: ganglion impar block |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale
from 0 to 10 as 0 no pain and 10 the worst pain
Measured: two months
Participant satisfaction reporting scale (PSRS)
it is 5 item self questionnaire1. How well was your pain problem explained to you during treatment?2. Did you agree with the types of treatments and recommendations that you received? 3. How satisfied were you with the care that you received in the Spine Care Center/ Anesthesiology Clinic? 4. Rate your overall improvement since starting treatment: 5. Rate your level of satisfaction with your improvement since starting treatment.
Measured: two months
Secondary outcomes (3)
Number of participants with post block complication
as hematoma, hypotension, neurological defect
Measured: 2 hours
success rate of block
percentage of patients who have numerical rating scale < 4 after one week from block
Measured: one week
Pain Anxiety symptoms scale (PASS).
from 0 to 6 points as 0 = never and 5= always
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start12 Jun 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion29 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PhantomStudies of the same condition, open and under way.
- More trials run by Mansoura 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevert Adel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694639
- Sponsor's protocol ID
- MansouraU2
- Status last verified
- Mar 2019
- First submitted
- 29 Sep 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-guided Ganglion Impar Block for Management of Phantom Rectal Pain Syndrome
- ClinicalTrials.gov ID
- NCT03694639
- Acronym / sponsor ID
- MansouraU2
- Conditions
- Pain, Phantom
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 29 Jul 2019 (estimated)
- First posted
- 3 Oct 2018 (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.
Background:Patients underwent abdominoperineal resection with colostomy may suffered from phantom rectum pain syndrome in the perineal area.In this study, the investigators evaluate the combination between ganglion impar block to pregabaline in the treatment of phantom rectal pain syndrome.
Method: Forty patients were randomly allocated into 2 groups: Group A (n=20) where patients received pregabaline 150 mg twice daily. Group B (n=20) where patients received pregabaline 150 mg twice daily plus ganglion impar block using 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone.
Detailed description
Introduction:
Phantom pain syndromes are mostly recorded after amputation of limbs, but it may affect any part of the body (visceral or somatic) has sensory perception following its removal as breast, teeth or rectum.
Patients underwent abdominoperineal resection with colostomy may suffered from phantom rectum pain syndrome in the perineal area characterized as pins, needles, stinging, and burning occurring mostly in sitting positions.
phantom rectum pain syndrome is rarely reported and it is varies from individual to individual. The presence of preoperative rectal pain has a good correlation for the development of postoperative phantom pain.
The pathophysiological mechanisms of phantom phenomena is still unknown but it is neuropathic in nature and believed that it is initiated by changes arising at the peripheral, spinal and supraspinal level leading to central reorganization in additional to the psychogenic factor.
Ganglion impar is a sympathetic ganglion used to manage acute or chronic perineal pain, situated directly in front of the coccyx around the sacrococcygeal joint and behind the rectum in the retroperitoneal space. It can be reached by any guidance as fluoroscopy, computerized tomography, or ultrasound.
Ganglion impar can be done by using multiple methods such as of local anesthetics with steroids or neurolysis by phenol, alcohol and radiofrequency.
The proposal of this study: Is to find the efficacy of the ganglion impar block in patients suffering from phantom rectal pain syndrome after abdominoperineal surgery for rectal cancer with colostomy.
Aim of the work:
To evaluate the combination between ganglion impar block to pregabaline in the treatment of phantom rectal pain syndrome.
Hypothesis:
Management of phantom rectal pain syndrome is a challenging issue needing more appropriate method to reach the best result.
Recharge Gap:
there is a no researches discuss this issue and how to manage it in best way.
Patients and methods:
Study design and participants This randomized pilot controlled study was conducted in pain clinic, Oncology Hospital, Mansoura University during the period from June 2018 till December 2018. The study was accepted by the institutional research board(R.18.09.288 ) . Written informed consents were obtained from forty patients aged from 18 to 70 years of either sex complained from phantom rectal pain syndrome after abdominoperineal surgery for rectal cancer with colostomy.
Patient exclusion criteria include: those who refused to share, evidence of local infection at the puncture site, allergy to drugs used, patients with bleeding tendency or coagulopathy, renal or hepatic failure, cardiac patients, bony abnormality and local malignant recurrence or lower vertebral metastasis.
Routine investigations as complete blood count, coagulation profile (partial thromboplastin time (PTT), prothrombin activity and international normalized ratio (INR)), liver and renal function tests were done prior to procedure. All patients were learned and assessed by numerical rating scale (NRS) for the intensity of pain (If no pain the score was equal zero, if it is worst pain imaginable the score was equal 10).
Sample size:
Internal pilot sample size was estimated on 8 patients during the following period using G-power analysis , assuming α (type I error)=0.05 and β (type II error)= 0.2 (power= 80%) calculate a total sample size of 40.
Patients were randomly allocated into 2 groups:
Group A (n=20) where patients received pregabaline 150 mg twice daily. Group B (n=20) where patients received pregabaline 150 mg twice daily plus ganglion impar block using 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone.
Technique:
Patients were placed in prone position with a cushion under their lower abdomen. CT sections were done in the axial plane 4 mm slice thickness to detect the site of sacrococcygeal disk. After a suitable section was confirmed, two distances were measured, one from patient's spine to the proper site of entry and the other from the site of entry to the target point. Also the angle of needle entrance was calculated. The skin was marked and cleaned with an aseptic solution then anesthetized by 2 ml lidocaine 2%. 22 gauge spinal needle 12 cm was introduced until reach anterior to sacrococcygeal disk. When the needle tip location was ideal, 2 ml lidocaine mixed with1ml of radiopaque dye was injected. CT sagittal section was done to verify the retroperitoneal distribution of the dye. After good contrast spread confirmation, 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone was injected. The patients were observed for one hour after block to note any complication and were discharged at the same day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabaline group | No intervention | –where patients received pregabaline 150 mg twice daily. |
| Pregabaline plus ganglion impar block group | Active comparator | Other: ganglion impar blockwhere patients received pregabaline 150 mg twice daily plus ganglion impar block using 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- complained from phantom rectal pain syndrome after abdominoperineal surgery for rectal cancer with colostomy.
Key exclusion criteria (5 listed)
- those who refused to share
- evidence of local infection at the puncture site
- allergy to drugs used
- patients with bleeding tendency or coagulopathy, renal or hepatic failure, cardiac patients,
- bony abnormality and local malignant recurrence or lower vertebral metastasis.
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 |
|---|---|---|
| ganglion impar blockCT sections were done in the axial plane 4 mm slice thickness to detect the site of sacrococcygeal disk. After a suitable section was confirmed, two distances were measured, one from patient's spine to the proper site of entry and the other from the site of entry to the target point.22 gauge spinal needle 12 cm was introduced until reach anterior to sacrococcygeal disk. When the needle tip location was ideal, 2 ml lidocaine mixed with1ml of radiopaque dye was injected. CT sagittal section was done to verify the retroperitoneal distribution of the dye. After good contrast spread confirmation, 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone was injected | Other | Pregabaline plus ganglion impar block group |
Primary outcome
numerical rating scale
Time frame: two months
from 0 to 10 as 0 no pain and 10 the worst pain
Participant satisfaction reporting scale (PSRS)
Time frame: two months
it is 5 item self questionnaire1. How well was your pain problem explained to you during treatment?2. Did you agree with the types of treatments and recommendations that you received? 3. How satisfied were you with the care that you received in the Spine Care Center/ Anesthesiology Clinic? 4. Rate your overall improvement since starting treatment: 5. Rate your level of satisfaction with your improvement since starting treatment.
3 secondary outcomes
Number of participants with post block complication
Time frame: 2 hours
success rate of block
Time frame: one week
Pain Anxiety symptoms scale (PASS).
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ganglion impar block in people with Pain, Phantom, run by Mansoura 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 1 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 7 Mar 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yahya Mhamed Wahba, MD (01211313554, yahyawahba@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numerical rating scale (time frame: two months). The study lists 2 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 7 Mar 2019.