Sacral Erector Spinae Block for Pilonidal Sinus Surgery

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: Sacral erector spinae plane block

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Governorate
    • Cairo, Governorate, Egypt, 32511
      • Faculty of Medicine Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: 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
Placebo Comparator: 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	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	NRS scor for post operative pain scale from 0 to 100	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption.	Total opioid consumbtion in mg	24 hours
Lower limb motor affection	Modified Bromage scale for motor affection from 1 to 6	24 hours
Adverse effects	Side effect as nausea, vomiting, itching will be recorded	24 hours

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: rabab M habeeb, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Postoperative Complications; Pain; Neurologic Manifestations; Cysts; Pain, Postoperative; Pilonidal Sinus
• Other Study ID Numbers: ANET6_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No