Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery
Primary Purpose
Functional Endoscopic Sinus Surgery (FESS)
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bupivacaine
Ropivacaine
Normal Saline
Sponsored by

About this trial
This is an interventional treatment trial for Functional Endoscopic Sinus Surgery (FESS) focused on measuring ropivacaine, bupivacaine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Group B (n=20)
Group R (n=20):
Group S (n=20, Control):
Arm Description
Group B (n=20): The patients in this group were infiltrated with 3 mL of 0.5% bupivacaine.
Group R (n=20): The patients in this group were infiltrated with 3 mL of 0.5% ropivacaine.
Group S (n=20, Control): The patients in this group were infiltrated with 3 mL of normal saline.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to first administration of rescue analgesia was recorded.
Patient satisfaction score
Full Information
NCT ID
NCT03013361
First Posted
January 3, 2017
Last Updated
January 4, 2017
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT03013361
Brief Title
Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery
Official Title
Comparison Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block for Postoperative Analgesia After Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Endoscopic Sinus Surgery (FESS)
Keywords
ropivacaine, bupivacaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group B (n=20)
Arm Type
Active Comparator
Arm Description
Group B (n=20): The patients in this group were infiltrated with 3 mL of 0.5% bupivacaine.
Arm Title
Group R (n=20):
Arm Type
Active Comparator
Arm Description
Group R (n=20): The patients in this group were infiltrated with 3 mL of 0.5% ropivacaine.
Arm Title
Group S (n=20, Control):
Arm Type
Placebo Comparator
Arm Description
Group S (n=20, Control): The patients in this group were infiltrated with 3 mL of normal saline.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Anawin
Intervention Description
Post operative pain control
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Ropin
Intervention Description
Post operative pain control
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Saline
Intervention Description
Acts as comparator
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Time to first administration of rescue analgesia was recorded.
Time Frame
8 hours
Title
Patient satisfaction score
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameer Sethi, MD
Organizational Affiliation
PGIMER, Chandigarh,India
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
1. Ali A, Sakr S, Rahman A. Bilateral sphenopalatine ganglion block as adjuvant to general anaesthesia during endoscopic trans-nasal resection of pituitary adenoma. Egypt J Anaesth 2010;26;273-280. 2. Friedman M, Venkatesan TK, Lang D, Caldarelli DD. Bupivacaine for postoperative analgesia following endoscopic sinus surgery. Laryngoscope 1996;106:1382-1385. 3. Bicer C, Eskıtascıoglu T, Aksu R, Ulgey A, Yildiz K, Madenoglu H. Comparison of Preincisional Infiltrated Levobupivacaine and Ropivacaine for Acute Postoperative Pain Relief After Septorhinoplasty. Curr Ther Res Clin Exp 2011;72:13-22. 4. Fernandes SV. Postoperative care in functional endoscopic sinus surgery. Laryngoscope 1999;109:945-948.
Results Reference
result
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Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery
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