Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery

Postoperative Pain Clinical Trial

Official title:

Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04110132
• Other study ID #: 16/70-8/2/2017
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.

Exclusion Criteria:

• Coagulation effects

• Allergy to Bupivacaine

• Previous anal surgery

• Patient refusal

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	VAS sore 0-10	24 hours
Secondary	First request of pain medications will be measured.	Time in hours	24 hours