Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 3

Conditions: Functional Endoscopic Sinus Surgery (FESS)

Treatments: Drug: Ropivacaine; Drug: Bupivacaine; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03013361

9157/PG2Trg/2012/15727

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Group B (n=20)

Active Comparator group

Description:

Group B (n=20): The patients in this group were infiltrated with 3 mL of 0.5% bupivacaine.

Treatment:

Drug: Bupivacaine

Group R (n=20):

Active Comparator group

Description:

Group R (n=20): The patients in this group were infiltrated with 3 mL of 0.5% ropivacaine.

Treatment:

Drug: Ropivacaine

Group S (n=20, Control):

Placebo Comparator group

Description:

Group S (n=20, Control): The patients in this group were infiltrated with 3 mL of normal saline.

Treatment:

Other: Normal Saline