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Completed

NCT Number: NCT04020393

The Effect of Sphenopalatine Ganglion Block in Patients Undergoing Septorhinoplasty

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.

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Key information

Conditions

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

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

The Effect of Sphenopalatine Ganglion Block on the Postoperative Pain in Patients Undergoing Septorhinoplasty

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2019
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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