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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
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Endoscopic Sinus Surgery (FESS) focused on measuring ropivacaine, bupivacaine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

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

    First Posted
    January 3, 2017
    Last Updated
    January 4, 2017
    Sponsor
    Postgraduate Institute of Medical Education and Research
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    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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