NCT03013361

Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Functional Endoscopic Sinus Surgery (FESS)

Interventions

Type	Name	Description
DRUG	Bupivacaine	Post operative pain control
DRUG	Ropivacaine	Post operative pain control
OTHER	Normal Saline	Acts as comparator

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2017-01-06
• Last updated: 2017-01-06