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The Effect of Sphenopalatine Ganglion Block in Patients Undergoing Septorhinoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04020393
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Nazan Degirmenci, Bezmialem Vakif University

Brief Summary:
The investigators reviewed retrospectively the patients that had received septorhinoplasty(SRP). 42 patients were included in the study. Demographic, clinical, surgical, and follow-up data were collected from clinical case notes. The patients that had received sphenopalatine ganglion block(SPGB) before the surgery included in the Block group (n:20) and the patients that had not received SPBG before the surgery included in the Control group (n:22). The postoperative pain(POP) scores, the amount of postoperative rescue analgesics that was used, and the postoperative nausea and vomiting(PONV) scores in the first 24 hours and, mean arterial pressure (MAP), the dose of Remifentanil that was used during the operation were compared between the groups.

Condition or disease Intervention/treatment
Pain, Postoperative Procedure: SPGB

Detailed Description:

The patients that had received SRP surgery between January-July 2019, divided into two groups according to the status of receiving SPGB before the surgery. The SPGB was done after the patient anesthetized and performed by the operating surgeon using a transnasal endoscopic approach through the posterior and over the middle turbinate tail in the pterygopalatine fossa. The patient was placed in the supine position with head extension. The prepared solution (4 cc % 4 lidocaine and 1 cc 8 mg dexamethasone) was delivered by a Mucosal Atomization device (LMA MADgic™ Laryngo-Tracheal Mucosal Atomization Device, US). 2,5 cc of the prepared solution was given to each side of the nose. The surgery was started 10 minutes after the application of SPBG, to allow sufficient time for the block to develop.

The open septorhinoplasty technique was done to all patients. The operations were done by the same two otorhinolaryngologists. Control group patients did not receive SPBG and had the surgery only. POP scores were questioned at both groups and postoperative analgesic protocols were the same.

POP was questioned by an anesthesiologist with a numeric rating scale (NRS) (0 = no pain, 10 = most severe pain) at the 30th minute(t1), 1st hour(t2), 4th hour (t3), 12th hour (t4) and 24th hours (t5) and analgesia was managed according to the NRS scores. If the NRS score was > 4, the patient was given Paracetamol 1000mg intravenously, and if the score was still >4 after 30 minutes the patient was given Tramadol 50 mg intravenously. Tramadol was used as rescue analgesia.

PONV was also evaluated. The data of nausea and vomiting were collected by direct questioning by the anesthesiologist at the same times with NRS questioning.

POP scores, the amount of postoperative rescue analgesics that was used, and PONV scores in the first 24 hours were compared between the groups.

Mean arterial pressure (MAP), and the dose of Remifentanil that was used during the operation were also compared between the groups.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Effect of Sphenopalatine Ganglion Block on the Postoperative Pain in Patients Undergoing Septorhinoplasty
Actual Study Start Date : January 10, 2019
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 10, 2019

Group/Cohort Intervention/treatment
Block group
The patients that had received Sphenopalatine ganglion block(SPGB) before the surgery
Procedure: SPGB
SPGB was performed by the operating surgeon using a transnasal endoscopic approach before septorhinoplasty in the Block group. The prepared solution (4 cc % 4 lidocaine and 1 cc 8 mg dexamethasone) was delivered by a Mucosal Atomization device (LMA MADgic™ Laryngo-Tracheal Mucosal Atomization Device, US). 2,5 cc of the prepared solution was given to each side of the nose.

Control Group
The patients that had not received SPBG before the surgery



Primary Outcome Measures :
  1. Postoperative pain(POP) [ Time Frame: 24 hour ]
    POP was questioned by an anesthesiologist with a numeric rating scale (NRS) (0 = no pain, 10 = most severe pain) at the 30th minute(min)(t1), 1st hour(h)(t2), 4th hour (t3), 12th hour (t4) and 24th hour (t5).

  2. Postoperative nausea and vomiting(PONV) [ Time Frame: 24 hour ]
    The data of PONV were collected by direct questioning by the anesthesiologist at the same times with POP questioning. If there is 1 min between the episodes of vomiting, each one was considered as separate episodes. Every episode of vomiting was scored as 1 point and total score was calculated after 24 hours.

  3. The dose of rescue analgesics [ Time Frame: 24 hour ]
    If the POP score was > 4, the patient was given Paracetamol 1000mg intravenously, and if the score was still >4 after 30 minutes the patient was given Tramadol 50 mg intravenously. The average dose of Paracetamol and Tramadol that were used at the first 24 hours were compared between the groups

  4. Mean arterial pressure(MAP) [ Time Frame: 80-240 minute ]
    MAP was recorded during the operation and the values were compared between the groups.

  5. The dose of Remifentanil [ Time Frame: 80-240 minute ]
    The dose of Remifentanil that was used during the operation was noted and compared between the groups.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
42 patients that have been operated between January 2019 and July 2019 at a tertiary referral center were included in the study. The patients that had received SPBG before the surgery included in the Block group (n:20) and the patients that had not received SPBG before the surgery included in the Control group (n:22).
Criteria

Inclusion Criteria:

  • The patients that had received SRP
  • The patients that had received SRP with SPGB
  • The patients that had all the necessary information for the study in their files

Exclusion Criteria:

  • The patients that had received additional surgery with SRP
  • The patients whose data were absent
  • The patients under the age of 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020393


Locations
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Turkey
Bezmialem Vakif University
Istanbul, Turkey
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Principal Investigator: Nazan Degirmenci Bezmialem Vakif University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nazan Degirmenci, Principal Investigator, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04020393    
Other Study ID Numbers: 12/232
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nazan Degirmenci, Bezmialem Vakif University:
septorhinoplasty
sphenopalatine ganglion
postoperative pain
Additional relevant MeSH terms:
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Ganglion Cysts
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases