Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery

NCT ID: NCT04110132

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2028-07-01

Study Completion Date

2029-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Participant, care provider and outcomes assessors will not be aware of the used intervention.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ganglion impar block with Bupivacaine.

Intervention Type PROCEDURE

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.

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.

Group Type PLACEBO_COMPARATOR

Ganglion impar block with normal saline

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.

Exclusion Criteria

* Coagulation effects
* Allergy to Bupivacaine
* Previous anal surgery
* Patient refusal
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Hazem I. Ahmad Sabry

Lecturer of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohammad Hazem I Ahmad Sabry, MD

Role: CONTACT

+201062718827

References

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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.

Reference Type BACKGROUND
PMID: 27614384 (View on PubMed)

Other Identifiers

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16/70-8/2/2017

Identifier Type: -

Identifier Source: org_study_id

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