Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery

NCT04110132 | Not Yet Recruiting

• 1 other identifier: 16/70-8/2/2017
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  VAS sore 0-10

  24 hours

Secondary Outcomes (1)

• First request of pain medications will be measured.

  24 hours

Study Arms (2)

Ganglion impar block with Bupivacaine.

ACTIVE COMPARATOR

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

Procedure: Ganglion impar block with Bupivacaine.

Ganglion impar block with Saline

PLACEBO COMPARATOR

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

Procedure: Ganglion impar block with normal saline

Interventions

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 Bupivacaine.

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.

Ganglion impar block with Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alexandria: lead

Related 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.

  PMID: 27614384 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Mohammad Hazem I Ahmad Sabry, MD

CONTACT

+201062718827; mohammad_hazem@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant, care provider and outcomes assessors will not be aware of the used intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Model Details: 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

Study Record Dates

• First Submitted: May 5, 2018
• First Posted: October 1, 2019
• Study Start (Estimated): July 1, 2028
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share