Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04657952
Other study ID # 34268/11/20
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date December 10, 2020
Est. completion date May 20, 2021

Study information

Verified date December 2020
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date May 20, 2021
Est. primary completion date May 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Intervention

Procedure:
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.
Drug:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours Efficacy 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
48 hours
Secondary Onset of analgesia The onset time till VAS= 4 48 hours
Secondary Duration of analgesia Duration with VAS< 4 48 hours
Secondary Adverse events Local anesthetic toxicity, hypertension, postoperative epistaxis, cheek hematoma and hypoesthesia of the palate 48 hours
See also
  Status Clinical Trial Phase
Completed NCT04091321 - Association Between Chronic Headache and Back Pain With Childbirth
Recruiting NCT05202574 - Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section Phase 2
Terminated NCT02813655 - Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE) Phase 2
Completed NCT02522013 - Aminophylline for Patients With Post-Dural Puncture Headache Phase 3
Recruiting NCT06444737 - Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia N/A
Completed NCT05301387 - The Effect of Ganglion Sphenopalatine Block (GSP-block) Follow-Up
Recruiting NCT05637645 - Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section N/A
Recruiting NCT05116930 - Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture Phase 2
Terminated NCT03430531 - Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache Phase 2
Completed NCT04401878 - SGB in Management of Patients With PDPH Using TCD N/A
Completed NCT04327726 - Effectiveness of Nebulized Dexmedetomidine for Treatment of Obstetric Post-Dural Puncture Headache N/A
Completed NCT03475784 - Two Fluid Strategies for Prevention of Post-dural Puncture Headache Phase 3
Not yet recruiting NCT06272916 - Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section.
Terminated NCT02827058 - The Influence of Needle Diameter on Post Dural Puncture Headache N/A
Completed NCT05262933 - Effects of Preoperative Coffee Consumption in Cesarean Sections Under Spinal Anesthesia
Completed NCT04793490 - Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients N/A
Recruiting NCT05888324 - Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch in Post Partum
Completed NCT00370604 - Effect of Small Versus Large Epidural Needles on Postdural Puncture Headache Study N/A
Completed NCT04844229 - Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache N/A
Withdrawn NCT03560349 - RCT of SPG Blocks for Post-dural Headache Phase 2