Comparison of the effects of adding drug fentanyl via two different routes in patients undergoing cataract surgeries.

Recruiting

• Conditions: ASA grade I/II/III patients posted for elective cataract surgeries

• Registration Number: CTRI/2018/04/013177
• Lead Sponsor: Bhagat Phool Singh Government Medical College for Women

Brief Summary

Regional anaesthesia has gained popularity overgeneral anaesthesia owing to lesser complications, better post-operativeanalgesia and better patient compliance due to faster recovery. Cataractsurgeries are generally performed under regional anaesthesia (peribulbar block)due to short duration of surgery and ease of administration. Several drugs havebeen added as adjuvants to local anaesthetic used in peribulbar block in orderto achieve faster onset of lid and globe akinesia (to start the surgery), toprolong the duration of postoperative analgesia and to minimise the analgesicrequirement. In our study, we aim to compare the effect of adding fentanyl asadjuvant to local anaesthetic solution via two routes, i.e., peribulbar andintravenous. A total of 160 patients will be randomly divided into 2 groupswith 80 patients in each group. Group A patients will receive 25µg of fentanyldiluted up to 1ml in normal saline along with peribulbar block and group Bpatients will receive intravenous fentanyl (1µg/kg) diluted up to 10ml innormal saline prior to peribulbar block. Peri-operatively, all the patientswill be monitored for vitals such as blood pressure, pulse, respiratory rate,spo2 and ECG. Duration of analgesia, time for rescue analgesic and number ofanalgesic doses needed to relieve the pain will be recorded in both groupspostoperatively upto 24 hours. Thereafter, comparisons will be made among the twogroups based on the data collected. The different variables and occurrence ofside effects, if any, would also be noted and compared amongst both groups. Theanticipated outcome of the study will be in terms of duration of analgesia bydifferent routes and patient and surgeon satisfaction satisfaction scores.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-03-25
• Study Start: 2018-05-02

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 1.American society of anaesthesiologists (ASA) grade I to III patients.
• 2.Patients in the age group of 40-80 years will be included in the study.
• 3.Patients of all genders.
• 4.Patients who are willing to provide their voluntary written informed consent for participation in the study.

Exclusion Criteria

• 1.Patients who are not willing to give their consent for participation in the present study.
• 2.History of allergy to the drug under study or local anaesthetics used.
• 3.Patients who have known coagulation abnormalities, patients with impaired orbital and periorbital sensation, disturbed conscious level, active respiratory disease, poor communication ability as deafness and patients with excessive tremors or agitations.
• 4.Patients with abnormal ocular conditions as vitreous haemorrhage, posterior staphyloma and glaucoma.
• 5.Patients previously on treatment with chronic analgesics and antipsychotic drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analgesic efficacy of fentanyl and duration of analgesia by different routes.	From the time of administration of fentanyl to maximum of 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Side effects and patient and surgeon satisfaction scores.	From the time of administration of fentanyl to maximum of 24 hours postoperatively.

Trial Locations

Locations (1)

Operation theatre complex, Department of Anaesthesiology; 🇮🇳 Sonipat, HARYANA, India

Operation theatre complex, Department of Anaesthesiology

🇮🇳Sonipat, HARYANA, India

Netakani Navajeevan

Principal investigator

9728223941

nanixmen@gmail.com