Postoperative PainNCT04110132
Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery
A study testing Ganglion impar block with Bupivacaine. and Ganglion impar block with normal saline in people with Postoperative Pain, run by University of Alexandria.
Trial summary
The aim of this study is to evaluate the ganglion Impar block in the prevention of postoperative pain after anal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ganglion impar block with Bupivacaine. and Ganglion impar block with normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2028to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.
Who cannot join
- Coagulation effects
- Allergy to Bupivacaine
- Previous anal surgery
- Patient refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to evaluate the ganglion Impar block in the prevention of postoperative pain after anal surgery.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Ganglion impar block with Bupivacaine., Ganglion impar block with normal saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganglion impar block with Bupivacaine.Procedure or surgery
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 salineProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Ganglion impar block with normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
VAS sore 0-10
Measured: 24 hours
Secondary outcomes (1)
First request of pain medications will be measured.
Time in hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Jul 2028 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Hazem I. Ahmad Sabry, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110132
- Sponsor's protocol ID
- 16/70-8/2/2017
- Status last verified
- Mar 2025
- First submitted
- 5 May 2018
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27614384
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia Using Ganglion Impar Block After Anal Surgery
- ClinicalTrials.gov ID
- NCT04110132
- Acronym / sponsor ID
- 16/70-8/2/2017
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 1 Jul 2028 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Ganglion impar block with Bupivacaine. | Active comparator | Procedure: 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 Saline | Placebo comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing hemorrhoidectomy surgery in Alexandria University hospital.
Key exclusion criteria (4 listed)
- Coagulation effects
- Allergy to Bupivacaine
- Previous anal surgery
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Ganglion impar block with Bupivacaine. |
| Ganglion impar block with normal salineSaline 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. | Procedure or surgery | Ganglion impar block with Saline |
Primary outcome
Postoperative pain
Time frame: 24 hours
VAS sore 0-10
1 secondary outcome
First request of pain medications will be measured.
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 27614384Cardaillac 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.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ganglion impar block with Bupivacaine. and Ganglion impar block with normal saline in people with Postoperative Pain, run by University of Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Hazem I Ahmad Sabry, MD (+201062718827, mohammad_hazem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04110132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.