Clinical trial NCT04110132: Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery
Official title: Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.

Exclusion Criteria:

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

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: First request of pain medications will be measured.
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: 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.