Sphenopalatine Ganglion Block for Post-Dural Puncture Headache in Orthopedic Patients

NCT ID: NCT04657952

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2021-05-20

Brief Summary

The aim of this study is to assess the efficacy, onset and duration of analgesia of sphenopalatine ganglion bock (SPGB) using lidocaine 4% with adrenaline as a treatment of postoperative Post dural puncture headache (PDPH) of orthopedic patients after lower limbs surgeries.

Conditions

Sphenopalatine Ganglion Block; Adrenaline; Post-Dural Puncture Headache; Orthopedic; Randomized Controlled Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard medical Treatment (paracetamol)

Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day.

Group Type: ACTIVE_COMPARATOR

Medical Treatment

Intervention Type: DRUG

Patients will receive paracetamol 1 gm 6 hours daily intravenously for a day. If adequate pain relief will not be achieved, intravenous diclofenac 75 mg twice daily will be added.

Sphenopalatine block

Patients will receive sphenopalatine block

Group Type: EXPERIMENTAL

Sphenopalatine Ganglion Block

Intervention Type: PROCEDURE

Sphenopalatine Ganglion Block will be performed by a transnasal approach. Few drops of lidocaine 2% will be instilled into both anterior nares. Then a cotton-tipped applicator soaked in 4% lignocaine \& adrenaline (1 to 200000 will be passed through both the nares and the end of the applicator tip will be positioned just superior to the middle turbinate and anterior to the pterygopalatine fossa and sphenopalatine ganglion for 5 min with the patient in the supine position.

Interventions

Sphenopalatine Ganglion Block

Sphenopalatine Ganglion Block will be performed by a transnasal approach. Few drops of lidocaine 2% will be instilled into both anterior nares. Then a cotton-tipped applicator soaked in 4% lignocaine \& adrenaline (1 to 200000 will be passed through both the nares and the end of the applicator tip will be positioned just superior to the middle turbinate and anterior to the pterygopalatine fossa and sphenopalatine ganglion for 5 min with the patient in the supine position.

Intervention Type: PROCEDURE

Medical Treatment

Patients will receive paracetamol 1 gm 6 hours daily intravenously for a day. If adequate pain relief will not be achieved, intravenous diclofenac 75 mg twice daily will be added.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Admitted to the orthopedic department
• Complaining of criteria of severe post-dural puncture headache within 7 days following subarachnoid block used for lower limbs surgeries.
• American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion Criteria

• Patient refusal or uncooperative.
• Patients with uncontrollable hypertension.
• Patient with known coagulopathy.
• Patient with nasal septal deviation, polyp, history of nasal bleeding.
• Patient with allergy to local anesthetics
• American Society of Anesthesiologists physical status>2.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Hussen Gamal Almawardy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

34268/11/20

Identifier Type: -

Identifier Source: org_study_id