NCT03013361

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

January 3, 2017

Last Update Submit

January 4, 2017

Conditions

Functional Endoscopic Sinus Surgery (FESS)

Keywords

ropivacaine, bupivacaine

Outcome Measures

Primary Outcomes (1)

  • 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

    30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.

Secondary Outcomes (2)

  • Time to first administration of rescue analgesia was recorded.

    8 hours

  • Patient satisfaction score

    8 hours

Study Arms (3)

Group B (n=20)

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Group R (n=20):

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Group S (n=20, Control):

PLACEBO COMPARATOR

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

Other: Normal Saline

Interventions

BupivacaineDRUG

Post operative pain control

Also known as: Anawin
Group B (n=20)
RopivacaineDRUG

Post operative pain control

Also known as: Ropin
Group R (n=20):
Normal SalineOTHER

Acts as comparator

Also known as: Saline
Group S (n=20, Control):

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Interventions

BupivacaineRopivacaineSaline SolutionSodium Chloride

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Sameer Sethi, MD

    PGIMER, Chandigarh,India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 6, 2017

Study Start

July 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 6, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share