Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery

NCT04110132 — Not applicable, Not yet recruiting, 60 participants, University of Alexandria

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RegistryNCT04110132
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment60 (Estimated)
SponsorUniversity of Alexandria (Other)
ConditionsPostoperative Pain
InterventionsGanglion impar block with Bupivacaine., Ganglion impar block with normal saline (Procedure)
Datesstart 2028-07-01 (estimated), primary completion 2029-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2019-10-01, last updated 2025-04-03

Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Pain All trials of Ganglion impar block with Bupivacaine. All trials of Ganglion impar block with normal saline

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Ganglion impar block with Bupivacaine.Active comparatorProcedure: 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.
Ganglion impar block with SalinePlacebo comparatorProcedure: Ganglion impar block with normal salineSaline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml Patient will have hemorrhoidectomy.
  • Ganglion impar block with Bupivacaine. (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 normal saline (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.

+Outcome measures

Primary outcomes

  • Postoperative pain [24 hours]: VAS sore 0-10

Secondary outcomes

  • First request of pain medications will be measured. [24 hours]: Time in hours

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.

Exclusion Criteria:

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

+Publications

  • 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. PMID 27614384