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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03013361
Enrollment
60
Registered
2017-01-06
Start date
2013-07-31
Completion date
2014-12-31
Last updated
2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Endoscopic Sinus Surgery (FESS)

Keywords

ropivacaine, bupivacaine

Brief 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.

Interventions

DRUGBupivacaine

Post operative pain control

DRUGRopivacaine

Post operative pain control

OTHERNormal Saline

Acts as comparator

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 surgery30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.

Secondary

MeasureTime frame
Time to first administration of rescue analgesia was recorded.8 hours
Patient satisfaction score8 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026