Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery

January 4, 2017 updated by: Dr Sameer Sethi, Postgraduate Institute of Medical Education and Research

Comparison Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block for Postoperative Analgesia After Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group B (n=20)
Group B (n=20): The patients in this group were infiltrated with 3 mL of 0.5% bupivacaine.
Drug: Bupivacaine
Post operative pain control
Other Names:
  • Anawin
ACTIVE_COMPARATOR: Group R (n=20):
Group R (n=20): The patients in this group were infiltrated with 3 mL of 0.5% ropivacaine.
Drug: Ropivacaine
Post operative pain control
Other Names:
  • Ropin
PLACEBO_COMPARATOR: Group S (n=20, Control):
Group S (n=20, Control): The patients in this group were infiltrated with 3 mL of normal saline.
Other: Normal Saline
Acts as comparator
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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 surgery
Time Frame: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.
30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first administration of rescue analgesia was recorded.
Time Frame: 8 hours
8 hours
Patient satisfaction score
Time Frame: 8 hours
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Sameer Sethi, MD, PGIMER, Chandigarh,India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 4, 2017

First Posted (ESTIMATE)

January 6, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9157/PG2Trg/2012/15727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Functional Endoscopic Sinus Surgery (FESS)

Clinical Trials on Bupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe