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

Sphenopalatine Ganglion Block With Adrenaline Additive for Post-Dural Puncture Headache in Orthopedic Patients: A Randomized Controlled Study

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04657952
Enrollment
60
Registered
2020-12-08
Start date
2020-12-10
Completion date
2021-05-20
Last updated
2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDURESphenopalatine 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.

DRUGMedical 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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours48 hoursEfficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours. VAS ranges from 0 to 10; 10 with worse outcome

Secondary

MeasureTime frameDescription
Onset of analgesia48 hoursThe onset time till VAS≥ 4
Duration of analgesia48 hoursDuration with VAS\< 4
Adverse events48 hoursLocal anesthetic toxicity, hypertension, postoperative epistaxis, cheek hematoma and hypoesthesia of the palate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026