The Effect of Sphenopalatine Ganglion Block in Patients Undergoing Septorhinoplasty

NCT04020393 | Completed

• 1 other identifier: 12/232
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

septorhinoplasty; sphenopalatine ganglion; postoperative pain

Outcome Measures

Primary Outcomes (5)

• Postoperative pain(POP)

  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).

  24 hour

• Postoperative nausea and vomiting(PONV)

  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.

  24 hour

• The dose of rescue analgesics

  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

  24 hour

• Mean arterial pressure(MAP)

  MAP was recorded during the operation and the values were compared between the groups.

  80-240 minute

• The dose of Remifentanil

  The dose of Remifentanil that was used during the operation was noted and compared between the groups.

  80-240 minute

Study Arms (2)

Block group

The patients that had received Sphenopalatine ganglion block(SPGB) before the surgery

Procedure: SPGB

Control Group

The patients that had not received SPBG before the surgery

Interventions

SPGB PROCEDURE

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.

Block group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32090594 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nazan Degirmenci

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: January 10, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 10, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)