Post Operative PainNCT06577064
Sacral Erector Spinae Block for Pilonidal Sinus Surgery
A study testing Sacral erector spinae plane block in people with Post Operative Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
The incidence of pilonidal sinus disease (PD) is estimated to be around 26/100,000 individuals mostly men.PD can cause the development of abscess or a draining sinus tract and that may lead to a loss of productive power and long-term morbidity.Different surgical technique approaches were proposed for treatment with… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Sacral erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >18 years old
- ASA physical status 1-3
Who cannot join
- ASA >3
- Opioid use within the previous 3 months
- Deranged coagulation parameters
- Patient refusal
- Allergy to local anesthetic medication.
- Preoperative neurological deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sacral Erector Spinae Block for Pilonidal Sinus Surgery: A Randomized Controlled Trial
The incidence of pilonidal sinus disease (PD) is estimated to be around 26/100,000 individuals mostly men.PD can cause the development of abscess or a draining sinus tract and that may lead to a loss of productive power and long-term morbidity.Different surgical technique approaches were proposed for treatment with different rates of success.
Read the detailed description
Sacral erector spinae plane block was first described by Tulgar et al. To provide sensory blockade in the parasacral region in two cases who had pilonidal sinus surgeries. Since then, the block was used for multiple surgeries like anorecatal, hip surgery and parasacral reconstructive surgeries.After obtaining the ethical committee approval from Menoufia University. patients scheduled for pilonidal sinus surgery will be randomly allocated into one of two groups Patients will be randomized to a study group using a computer-generated random number table, and the allocation concealment will be performed using a sealed envelope technique.The sealed opaque envelopes will be kept locked in dedicated research safe and will be accessed by a research coordinator only when a patient consented for the study. The anesthetist will perform the intervention with the doses and concentration of drugs as per the protocol.
The patients and the follow up researcher will be blinded to the type of intervention used. The patient follow-up time will be scheduled intraoperatively PACU, 1 hour and 24hours postoperatively. The anesthetist who did the intervention will have no access to the reported documents or contact with the patient postoperatively.
For induction of anesthesia all patients will receive medication as per the facility protocol where propofol 1-2mg/Kg, fentanyl 2μg/Kg (actual BW), rocuronium 0.5 mg/kg will be used for induction and an endotracheal tube intubation will be inserted to secure the airway. After intubation and confirmation of endotracheal tube placement by auscultation and capnography, the patient will be turned into prone position.
Maintenance of anesthesia will be maintained by sevoflurane 1-1.2 MAC and rocuronium 0.1mg/kg guided by the TOF. All patients will receive multimodal analgesia in the form of paracetamol 1gm and parecoxib 40 mg (Pizer manufacturing Belgium). After exclusion of other causes of tachycardia and hypertension Morphine 2mg increments will be administrated to keep the heart rate or blood pressure within 20 percent of the patient's baseline parameters.
- Conditions
- Post Operative Pain
- Being tested
- Sacral erector spinae plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral erector spinae plane blockProcedure or surgery
30 ml of 0.2% ropivacaine will be injected in the plane between the ESM and sacrum on each side
| Study group | Role | What they receive |
|---|---|---|
| Sacral erector spinae plane block Group | Active comparator | 30 ml of 0.2% ropivacaine will be injected in the plane between the ESM and sacrum on each side While the patient is in prone position Receives: Procedure: Sacral erector spinae plane block |
| non-intervention group | Placebo comparator | patients will receive general anesthesia plus scheduled analgesia protocol in the form of morphine sulphate I.V. 1 mg every 5 minutes if NRS more than 5 till maximum dose 10 mg Receives: Procedure: Sacral erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
NRS scor for post operative pain scale from 0 to 100
Measured: 24 hours
Secondary outcomes (3)
Opioid consumption.
Total opioid consumbtion in mg
Measured: 24 hours
Lower limb motor affection
Modified Bromage scale for motor affection from 1 to 6
Measured: 24 hours
Adverse effects
Side effect as nausea, vomiting, itching will be recorded
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 posted29 Aug 2024
- Study start1 Nov 2023
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- andomized controlled trial.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab Mohammad habeeb, Menoufia University
- Investigators
- rabab M habeeb, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577064
- Sponsor's protocol ID
- ANET6_2
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Erector Spinae Block for Pilonidal Sinus Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06577064
- Acronym / sponsor ID
- ANET6_2
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 29 Aug 2024 (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 incidence of pilonidal sinus disease (PD) is estimated to be around 26/100,000 individuals mostly men.PD can cause the development of abscess or a draining sinus tract and that may lead to a loss of productive power and long-term morbidity.Different surgical technique approaches were proposed for treatment with different rates of success.
Detailed description
Sacral erector spinae plane block was first described by Tulgar et al. To provide sensory blockade in the parasacral region in two cases who had pilonidal sinus surgeries. Since then, the block was used for multiple surgeries like anorecatal, hip surgery and parasacral reconstructive surgeries.After obtaining the ethical committee approval from Menoufia University. patients scheduled for pilonidal sinus surgery will be randomly allocated into one of two groups Patients will be randomized to a study group using a computer-generated random number table, and the allocation concealment will be performed using a sealed envelope technique.The sealed opaque envelopes will be kept locked in dedicated research safe and will be accessed by a research coordinator only when a patient consented for the study. The anesthetist will perform the intervention with the doses and concentration of drugs as per the protocol.
The patients and the follow up researcher will be blinded to the type of intervention used. The patient follow-up time will be scheduled intraoperatively PACU, 1 hour and 24hours postoperatively. The anesthetist who did the intervention will have no access to the reported documents or contact with the patient postoperatively.
For induction of anesthesia all patients will receive medication as per the facility protocol where propofol 1-2mg/Kg, fentanyl 2μg/Kg (actual BW), rocuronium 0.5 mg/kg will be used for induction and an endotracheal tube intubation will be inserted to secure the airway. After intubation and confirmation of endotracheal tube placement by auscultation and capnography, the patient will be turned into prone position.
Maintenance of anesthesia will be maintained by sevoflurane 1-1.2 MAC and rocuronium 0.1mg/kg guided by the TOF. All patients will receive multimodal analgesia in the form of paracetamol 1gm and parecoxib 40 mg (Pizer manufacturing Belgium). After exclusion of other causes of tachycardia and hypertension Morphine 2mg increments will be administrated to keep the heart rate or blood pressure within 20 percent of the patient's baseline parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- andomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Sacral erector spinae plane block Group | Active comparator | Procedure: Sacral erector spinae plane block30 ml of 0.2% ropivacaine will be injected in the plane between the ESM and sacrum on each side While the patient is in prone position |
| non-intervention group | Placebo comparator | Procedure: Sacral erector spinae plane blockpatients will receive general anesthesia plus scheduled analgesia protocol in the form of morphine sulphate I.V. 1 mg every 5 minutes if NRS more than 5 till maximum dose 10 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age >18 years old
- ASA physical status 1-3
Key exclusion criteria (6 listed)
- ASA >3
- Opioid use within the previous 3 months
- Deranged coagulation parameters
- Patient refusal
- Allergy to local anesthetic medication.
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 |
|---|---|---|
| Sacral erector spinae plane block30 ml of 0.2% ropivacaine will be injected in the plane between the ESM and sacrum on each side | Procedure or surgery | Sacral erector spinae plane block Group, non-intervention group |
Primary outcome
Pain score
Time frame: 24 hours
NRS scor for post operative pain scale from 0 to 100
3 secondary outcomes
Opioid consumption.
Time frame: 24 hours
Lower limb motor affection
Time frame: 24 hours
Adverse effects
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
rabab M habeeb principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral erector spinae plane block in people with Post Operative Pain, run by Menoufia University at 1 site in Egypt.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.