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Completed

NCT Number: NCT03013361

Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery

Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. As the current evidences regarding the benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients undergoing FESS under general anaesthesia in this study.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Functional endoscopic sinus surgery (FESS) is a minimally invasive and safe technique for the treatment of sinonasal disease. Although it is a minimally invasive and less traumatic procedure, it is usually associated with pain of mild to moderate intensity which reaches its maximum level in the first few postoperative hours. However, even low-level postoperative pain may be associated with delayed functional recovery and it frequently contributes to dissatisfaction with the procedure delay in return to work and readmission after surgery. Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. As the sensory innervations of the SPG supplies the nasal turbinates, nasopharynx and palate, SPG block is expected to provide perioperative analgesia after FESS. Integration of regional anaesthesia with general anaesthesia technique can provide a better hemodynamic control, less perioperative opioid use, less bleeding and higher level of patients' satisfaction. Reduction in surgical bleeding in FESS can improve surgical field and also surgeons' satisfaction and a reduced opioid use may be translated into a less postoperative nausea & vomiting, rapid recovery and early hospital discharge. But, the current evidences regarding the benefit of SPG block after FESS is controversial. In this randomized controlled trial, efficacy of sphenopalatine ganglion block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients undergoing FESS under general anaesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 60 American Society of Anesthesiologists (ASA) physical status I and II patients
  • aged 18-60 years scheduled to undergo elective functional endoscopic sinus surgery for sinonasal disease such as rhinosinusitis, polyps and deviated nasal septum were enrolled

Exclusion criteria

  • Severe cardiovascular, pulmonary, hepatic, renal, neurologic or metabolic disease or coagulopathy
  • History of allergy to any of the medications being used in the study
  • Previous surgery for sinonasal disease
  • Pre-existing chronic pain not related to chronic rhinosinusitis
  • Taking prescription pain medications or antidepressants
  • Chronic alcohol or drug abuse
  • Inability to comprehend the study protocol
  • Pregnancy

Treatment and study plan

Bupivacaine

Drug

Post operative pain control

Other names: Anawin

Ropivacaine

Drug

Post operative pain control

Other names: Ropin

Normal Saline

Other

Acts as comparator

Other names: Saline

Primary outcomes

  1. Primary aim of the study was to assess the change in visual analogue scale comparing the effect of bilateral sphenopalatine ganglion block with bupivacaine and ropivacaine for postoperative analgesia after functional endoscopic sinus surgery

    Time frame: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.

Secondary outcomes

  1. Time to first administration of rescue analgesia was recorded.

    Time frame: 8 hours

  2. Patient satisfaction score

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

Comparison Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block for Postoperative Analgesia After Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2017
Registry last updated
Jan 6, 2017

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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