The Effect of Sphenopalatine Ganglion Block in Patients Undergoing Septorhinoplasty

NCT ID: NCT04020393

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2019-07-10

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.

Conditions

Pain, Postoperative

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Block group

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

SPGB

Intervention Type: 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.

Control Group

The patients that had not received SPBG before the surgery

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Nazan Degirmenci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nazan Degirmenci

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 32090594 (View on PubMed)

Other Identifiers

12/232

Identifier Type: -

Identifier Source: org_study_id