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Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ganglion impar block with Bupivacaine.
Ganglion impar block with normal saline
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.

Exclusion Criteria:

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

Sites / Locations

  • Alexandria Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ganglion impar block with Bupivacaine.

Ganglion impar block with Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative pain
VAS sore 0-10

Secondary Outcome Measures

First request of pain medications will be measured.
Time in hours

Full Information

First Posted
May 5, 2018
Last Updated
September 25, 2021
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT04110132
Brief Title
Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery
Official Title
Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participant, care provider and outcomes assessors will not be aware of the used intervention.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ganglion impar block with Bupivacaine.
Arm Type
Active Comparator
Arm Description
Bupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml. Patient will have hemorrhoidectomy.
Arm Title
Ganglion impar block with Saline
Arm Type
Placebo Comparator
Arm Description
Saline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml Patient will have hemorrhoidectomy.
Intervention Type
Procedure
Intervention Name(s)
Ganglion impar block with Bupivacaine.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ganglion impar block with normal saline
Intervention Description
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 Measure Information:
Title
Postoperative pain
Description
VAS sore 0-10
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
First request of pain medications will be measured.
Description
Time in hours
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing hemorrhoidectomy surgery in Alexandria University hospital. Exclusion Criteria: Coagulation effects Allergy to Bupivacaine Previous anal surgery Patient refusal
Facility Information:
Facility Name
Alexandria Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21111
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Hazem I Ahmad Sabry, MB,ChB MD
Phone
+2034842236
Email
mohammad_hazem@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27614384
Citation
Cardaillac C, Ploteau S, Labat JJ, Levesque A, Riant T. [Interest of infiltration of Impar node in rebel vulvodynia: About a series of 8 cases]. Prog Urol. 2016 Dec;26(17):1213-1221. doi: 10.1016/j.purol.2016.08.004. Epub 2016 Sep 7. French.
Results Reference
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Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery

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