Clinical trial NCT04020393: The Effect of Sphenopalatine Ganglion Block in Patients Undergoing Septorhinoplasty
Official title: The Effect of Sphenopalatine Ganglion Block on the Postoperative Pain in Patients Undergoing Septorhinoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: septorhinoplasty
sphenopalatine ganglion
postoperative pain
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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).

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.

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.

Eligibility 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

Primary outcomes:
measure: Postoperative pain(POP)
timeFrame: 24 hour
measure: Postoperative nausea and vomiting(PONV)
timeFrame: 24 hour
measure: The dose of rescue analgesics
timeFrame: 24 hour
measure: Mean arterial pressure(MAP)
timeFrame: 80-240 minute
measure: The dose of Remifentanil
timeFrame: 80-240 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Nazan Degirmenci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Degirmenci N, Ozdem A, Uysal H, Sen P, Senturk E, Ozturan O, Turkoz A. The Effect of Sphenopalatine Ganglion Block on the Postoperative Pain in Patients Undergoing Septorhinoplasty. Ann Otol Rhinol Laryngol. 2020 Jul;129(7):722-726. doi: 10.1177/0003489420909417. Epub 2020 Feb 22.