Clinical Research Directory

Acetazolamide to Reduce Spinal Fluid Leaks After Spine Surgery.

This study aims to evaluate the effectiveness and safety of acetazolamide in helping patients recover from accidental dural tears during spine surgery. Adding acetazolamide to standard post-surgery care is hypothesized to be a safe and effective way to reduce spinal fluid leakage, ease headaches, and speed up recovery.

Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics

The SNOB study is a prospective, randomized, double-blind, placebo-controlled, cross-over pragmatic trial that has been designed in accordance with the CONSORT guidelines. Patient recruitment will occur in the postnatal unit or emergency room, where the patient first presents with PDPH following epidural or CSE for labor or cesarean delivery. We will endeavor to perform anesthesia ward rounds daily in postnatal wards to assess for possible PDPH. Patients will also be identified who return to labor and delivery or the emergency room with complaints of headache following hospitalization that included epidural or CSE during delivery. The RCT intervention is sphenopalatine ganglion nerve block (SPGNB). The active drug is 4% lidocaine (LIDO group); placebo control is saline (SALINE group). The sphenopalatine ganglion is shown in Figure 1. Owing to its location at the posterior wall of the nasopharynx, the SPGNB is readily performed by non-invasive application of topical local anesthetic. Patients are positioned supine with a pillow under their shoulders with their chin raised, so that their neck is extended. Next, 1.5 mL of study drug (4% lidocaine solution or saline) is dripped slowly (over 15 seconds) into each nostril (total 3mL) via a plastic venflon i.v. cannula. The supine, extended-neck position is then maintained for 15 minutes. After that time, the patient is then asked to sit upright to assess the postural headache. If the postural headache is not sufficiently relieved, the procedure is immediately repeated, and may be repeated a third time if needed. Cross-over: After SPGNB, any patient with inadequate therapy (primary outcome; see below) may request to end the study and have an epidural blood patch. On initial enrollment they are advised that all patients requesting an epidural blood patch will be asked to receive an additional cross-over rescue dose of SPGNB which is the opposite of the drug (lidocaine or saline) allocated in their study group. Treatment for up to three 15 min intervals and subsequent assessment is exactly as for the study intervention (see above). If the PDPH is completely relieved by this cross-over medication, the patient will be advised to defer the EBP. If patients refuse the cross-over, this refusal is recorded but their initial request for EBP after the first series of randomized medications is analyzed as our primary endpoint. Outcomes: The primary outcome is initial success assessed after completion of the first series of SPGNB treatment with the study medication (LIDO vs SALINE) - irrespective of the number of treatments required (1, 2 or 3 applications, ie after 15, 30 or 45 min). There are two possible options at this stage: Adequate analgesia; patient does not wish to proceed to EBP; or Inadequate analgesia; patient wishes to proceed to EBP. Secondary outcomes: 1) Success or failure of the cross-over dose to treat PDPH and prevent EBP - irrespective of the number of treatments required (1, 2 or 3 applications, ie after 15, 30 or 45 min); 2) Number of repeat SPGNB treatments required for success in either the initial treatment series or the rescue cross-over series; 3) Time to headache on assuming upright posture; 4) Return to function using the Brief Pain Inventory http://www.npcrc.org/files/news/briefpain\_short.pdf - using the pain interference section (questions 9 A-G). 5) Standardized questionnaire (after each intervention): following questions - each with a binary answer Yes or No: Head/neck pain, Nausea, Photophobia, Tinnitus, Ear stuffiness, Diplopia. If the answer to head/neck pain is "yes", then there are supplementary questions: a) location, b) postural element to pain, c) time pain appears after upright posture, d) severity assessed by VAS 0-10 (11-point verbal scale), where 0=none and 10=worst imaginable.

A Trial of Absorbable Medical Adhesive for Prevention of CSF Leak

This is a multicenter, randomized, single-blind, positive-controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of an absorbable medical adhesive (developed by Guangzhou Maipu Regenerative Medical Technology Co., Ltd.) as an adjunctive method for dural repair in neurosurgery to prevent cerebrospinal fluid (CSF) leakage. A total of 132 subjects (1:1 randomization, 66 in the test group and 66 in the control group) were enrolled across 9 centers in China. The test device is an absorbable medical adhesive composed of polyethylene glycol (PEG) derivatives. The control device is the commercially available absorbable polymeric tissue sealing film (TissuePatchSF, TissueMed Ltd., UK NMPA Registration No. 20163641547). The primary efficacy endpoint is the success rate of postoperative prevention of CSF leakage (assessed at Day 7 ± 3 days post-surgery). Secondary efficacy endpoints include intraoperative CSF leak prevention success rate, postoperative subcutaneous fluid accumulation rate, and scalp incision healing. Safety endpoints include adverse events, serious adverse events, central nervous system infection, and pseudomeningocele. Subjects were followed for 3 months post-surgery. The study was completed in April 2021.

Immiseal™ Dural Sealant Post-Market Registry Study

This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct to standard methods of dural repair to provide watertight closure during neurosurgical procedures. Eligible adult subjects requiring dural repair after neurosurgical procedures or traumatic injury, for whom the investigator has made the clinical decision to use the device, will be enrolled and followed for approximately 100 ± 10 days after surgery.

Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery

The purpose of this clinical study is to evaluate and establish the safety and efficacy of the ArtiFix® device in subjects scheduled for cranial or spinal surgery that requires Dural repair (membrane that covers the brain and spinal cord). The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 30, 120 and 330 days after the procedure.

Effect of Spinal Needle Type on Optic Nerve Sheath Diameter

The optic nerve sheath is a continuation of the dura mater, extending along the subarachnoid space surrounding the optic nerve. Consequently, changes in intracranial pressure cause an augmentation or contraction in the diameter of the optic nerve sheath, which is coreleted with intracranial pressure. Participants undergoing lower extremity operations (ankle, distal tibia and fibula surgeries) using a tourniquet under spinal anesthesia will be investigated. Spinal anesthesia will be performed with a 25 G Whitacre, 25 G Quincke, or 27 G Quincke needle, depending on the study group. Optic nerve sheath diameter (ONSD) measurements will be performed before spinal anesthesia; and 5 minutes, 15 minutes,,24 hours after spinal block, respectively.The 4th measurement will be performed after tourniquet is opened. Measurements will be done with 15 MHz linear ultrasound (US) probe in B mode, 3 mm behind the posterior globe in the transverse plane from both eyes, on upper eyelid. Values will be recorded numerically. The impact of spinal anesthesia administered using various needle designs (Quincke and Whitacre) and sizes (25G-27G) on intracranial pressure will be investigated.