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

NCT03694639 | Unknown Phase 4

• 1 other identifier: MansouraU2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Phantom

Outcome Measures

Primary Outcomes (2)

• numerical rating scale

  from 0 to 10 as 0 no pain and 10 the worst pain

  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.

  two months

Secondary Outcomes (3)

• Number of participants with post block complication

  2 hours

• success rate of block

  one week

• Pain Anxiety symptoms scale (PASS).

  one week

Study Arms (2)

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.

Other: ganglion impar block

Interventions

ganglion impar block OTHER

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

Pregabaline plus ganglion impar block group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Yahay wahba

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Central Study Contacts

Yahya Mhamed Wahba, MD

CONTACT

01211313554; yahyawahba@ymail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 3, 2018
• Study Start: June 12, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 29, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

EG (1)