Sacral Erector Spinae Block for Pilonidal Sinus Surgery

NCT ID: NCT06577064

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-08-01

Brief 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 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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sacral erector spinae plane block Group

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

Group Type: ACTIVE_COMPARATOR

Sacral erector spinae plane block

Intervention Type: PROCEDURE

30 ml of 0.2% ropivacaine will be injected in the plane between the ESM and sacrum on each side

non-intervention group

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

Group Type: PLACEBO_COMPARATOR

Sacral erector spinae plane block

Intervention Type: PROCEDURE

30 ml of 0.2% ropivacaine will be injected in the plane between the ESM and sacrum on each side

Interventions

Sacral erector spinae plane block

30 ml of 0.2% ropivacaine will be injected in the plane between the ESM and sacrum on each side

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age >18 years old
• ASA physical status 1-3

Exclusion Criteria

1. ASA >3

2. Opioid use within the previous 3 months

3. Deranged coagulation parameters

4. Patient refusal

5. Allergy to local anesthetic medication.

6. Preoperative neurological deficits

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

rabab Mohammad habeeb

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rabab M habeeb

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Locations

Faculty of Medicine Menoufia University

Cairo, Governorate, Egypt

Countries

Egypt

Other Identifiers

ANET6_2

Identifier Type: -

Identifier Source: org_study_id