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Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110132
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Mohammad Hazem I. Ahmad Sabry, University of Alexandria

Brief Summary:
The aim of this study is to evaluate the ganglion Impar block in the prevention of postoperative pain after anal surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Ganglion impar block with Bupivacaine. Procedure: Ganglion impar block with normal saline Not Applicable

Detailed Description:

Postoperative analgesia using ganglion Impar block after anal surgery

Introduction

Ganglion Impar block may be used for treatment of chronic perineal pain (1) Aim

The aim of this study is to evaluate the ganglion Impar block in the prevention of postoperative pain after anal surgery.

Patients and Methods

After approval of local ethical committee and patient consent, this double blinded randomized study will be done on 60 patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.

After standard general anesthesia with Propofol 1-2mg/kg LMA for airway management and maintenance with Isoflurane 1%. The patient will be randomized into two groups.

Bupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml.

Saline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml Postoperative VAS will be measured each 1 for the first 6 hours then at 9 and 12 hours postoperative.

First request of pain medications will be measured.

Results Results will be collected in tables and graphs. Appropriate statistical analysis will be done.

Discussion Results of the study will be discussed compared to other studies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

After approval of local ethical committee and patient consent, this double blinded randomized study will be done on 60 patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.

After standard general anesthesia with Propofol 1-2mg/kg LMA for airway management and maintenance with Isoflurane 1%. The patient will be randomized into two groups.

Bupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml.

Saline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Participant, care provider and outcomes assessors will not be aware of the used intervention.
Primary Purpose: Treatment
Official Title: Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ganglion impar block with Bupivacaine.

Bupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml.

Patient will have hemorrhoidectomy.

Procedure: Ganglion impar block with Bupivacaine.

Bupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml.

Postoperative VAS will be measured each 1 for the first 6 hours then at 9 and 12 hours postoperative.


Placebo Comparator: Ganglion impar block with Saline
Saline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml Patient will have hemorrhoidectomy.
Procedure: Ganglion impar block with normal saline
Saline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml Postoperative VAS will be measured each 1 for the first 6 hours then at 9 and 12 hours postoperative.




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 24 hours ]
    VAS sore 0-10


Secondary Outcome Measures :
  1. First request of pain medications will be measured. [ Time Frame: 24 hours ]
    Time in hours



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.

Exclusion Criteria:

  • Coagulation effects
  • Allergy to Bupivacaine
  • Previous anal surgery
  • Patient refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110132


Locations
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Egypt
Alexandria Faculty of Medicine
Alexandria, Egypt, 21111
Contact: Mohammad Hazem I Ahmad Sabry, MB,ChB MD    +2034842236    mohammad_hazem@yahoo.com   
Sponsors and Collaborators
University of Alexandria
Publications:
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Responsible Party: Mohammad Hazem I. Ahmad Sabry, Lecturer of Anesthesia, University of Alexandria
ClinicalTrials.gov Identifier: NCT04110132    
Other Study ID Numbers: 16/70-8/2/2017
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents