Sacral Erector Spinae Block for Pilonidal Sinus Surgery

NCT06577064 | Completed

• 1 other identifier: ANET6_2
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Pain score

  NRS scor for post operative pain scale from 0 to 100

  24 hours

Secondary Outcomes (3)

• Opioid consumption.

  24 hours

• Lower limb motor affection

  24 hours

• Adverse effects

  24 hours

Study Arms (2)

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

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

Procedure: Sacral erector spinae plane block

Interventions

Sacral erector spinae plane block PROCEDURE

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

Sacral erector spinae plane block Group; non-intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• ASA \>3
• Opioid use within the previous 3 months
• Deranged coagulation parameters
• Patient refusal
• Allergy to local anesthetic medication.
• Preoperative neurological deficits

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine Menoufia University

Cairo, Governorate, 32511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• rabab M habeeb

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: andomized controlled trial.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: November 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)