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Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery

U

University of Alexandria

Status

Begins enrollment in a year or more

Conditions

Postoperative Pain

Treatments

Procedure: Ganglion impar block with normal saline
Procedure: Ganglion impar block with Bupivacaine.

Study type

Interventional

Funder types

Other

Identifiers

NCT04110132
16/70-8/2/2017

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Ganglion impar block with Bupivacaine.
Active Comparator group
Description:
Bupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml. Patient will have hemorrhoidectomy.
Treatment:
Procedure: Ganglion impar block with Bupivacaine.
Ganglion impar block with Saline
Placebo Comparator group
Description:
Saline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml Patient will have hemorrhoidectomy.
Treatment:
Procedure: Ganglion impar block with normal saline

Trial contacts and locations

1

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Central trial contact

Mohammad Hazem I Ahmad Sabry, MD

Data sourced from clinicaltrials.gov

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