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CT-guided Ganglion Impar Block for Management of Phantom Rectal Pain Syndrome

Primary Purpose

Pain, Phantom

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
ganglion impar block
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Phantom

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • complained from phantom rectal pain syndrome after abdominoperineal surgery for rectal cancer with colostomy.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Yahay wahbaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Pregabaline group

Pregabaline plus ganglion impar block group

Arm Description

where patients received pregabaline 150 mg twice daily.

where patients received pregabaline 150 mg twice daily plus ganglion impar block using 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone.

Outcomes

Primary Outcome Measures

numerical rating scale
from 0 to 10 as 0 no pain and 10 the worst pain
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.

Secondary Outcome Measures

Number of participants with post block complication
as hematoma, hypotension, neurological defect
success rate of block
percentage of patients who have numerical rating scale < 4 after one week from block
Pain Anxiety symptoms scale (PASS).
from 0 to 6 points as 0 = never and 5= always

Full Information

First Posted
September 29, 2018
Last Updated
March 6, 2019
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03694639
Brief Title
CT-guided Ganglion Impar Block for Management of Phantom Rectal Pain Syndrome
Official Title
CT-guided Ganglion Impar Block for Management of Phantom Rectal Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
July 29, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Phantom

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pregabaline group
Arm Type
No Intervention
Arm Description
where patients received pregabaline 150 mg twice daily.
Arm Title
Pregabaline plus ganglion impar block group
Arm Type
Active Comparator
Arm Description
where patients received pregabaline 150 mg twice daily plus ganglion impar block using 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone.
Intervention Type
Other
Intervention Name(s)
ganglion impar block
Intervention Description
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
Primary Outcome Measure Information:
Title
numerical rating scale
Description
from 0 to 10 as 0 no pain and 10 the worst pain
Time Frame
two months
Title
Participant satisfaction reporting scale (PSRS)
Description
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.
Time Frame
two months
Secondary Outcome Measure Information:
Title
Number of participants with post block complication
Description
as hematoma, hypotension, neurological defect
Time Frame
2 hours
Title
success rate of block
Description
percentage of patients who have numerical rating scale < 4 after one week from block
Time Frame
one week
Title
Pain Anxiety symptoms scale (PASS).
Description
from 0 to 6 points as 0 = never and 5= always
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: complained from phantom rectal pain syndrome after abdominoperineal surgery for rectal cancer with colostomy. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yahya Mhamed Wahba, MD
Phone
01211313554
Email
yahyawahba@ymail.com
Facility Information:
Facility Name
Yahay wahba
City
Mansourah
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yahya Mohamed Wahba, MD
Phone
01211313554
Email
yahyawahba@ymail.com

12. IPD Sharing Statement

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CT-guided Ganglion Impar Block for Management of Phantom Rectal Pain Syndrome

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