Clinical trial NCT04300595: Anesthetic Approaches for Dacryocystorhinostomy Surgery: The Effect of Adding Local Anesthesia to General Inhalational Anesthesia
Official title: The Efficacy of Combined Local and General Anesthesia or General Anesthesia Alone in External Dacryocystorhinostomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Effects of; Anesthesia, Local,Pain,in DISE
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-03-09
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The day before surgery and after obtaining written informed consent and full history taking, all patients were assigned randomly to receive either general anesthesia with intravenous opioids and local infiltration of saline (Group G) or general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L).
Primary purpose: SUPPORTIVE_CARE

Brief summary: To Study the effect of combination of of general anesthesia and local anesthesia in anesthesia for external dacryocystorhinostomy and assess quality of the procedure

Detailed description: * calculate the total requirement for anaesthetic agents to maintain satisfactory operating conditions
* calculate total anesthetic time
* assess intraoperative changes in hemodynamics
* assess intraoperative blood loss
* evaluate surgeon and patient satisfaction
* recognize whether this was related with changes in postoperative analgesia .
* Also occurrence of postoperative nausea was recorded and compared with general anaesthesia combined with intravenous opioid for (EXT-DCR) surgery.

Eligibility criteria: Inclusion Criteria:• Age from 20 to 50 years old.

* American society of anesthesiologists (ASA) physical status I or II.
* Elective unilateral Dacryocystorhinostomy with paranasal skin incision.

Exclusion Criteria:

* Endoscopic Dacryocystorhinostomy.
* Allergy to amide local anesthetics or opioids.
* Drug abuse.
* Pregnancy.

Primary outcomes:
measure: postoperative pain assessment
timeFrame: change in visual analogue scale at 1, 2, 4, 6, 8, 12, and 24 hours postoperative after extubation
measure: hemodynamic assessment
timeFrame: for 24 hours
measure: hemodynamic assessment
timeFrame: for 24 hours
Secondary outcomes:
measure: extubation time
timeFrame: intraoperative (from time of anesthesia ended till extubation and recorded in each patient in minutes)
measure: mean isoflurane %
timeFrame: intraoperative ( recorded every 5 minutes)
measure: time to rescue analgesia
timeFrame: up to 24 hours of postoperative
measure: The number of patients who required nalbuphine in the postoperative period,
timeFrame: up to 24 hours of postoperative
measure: intraoperative bleeding
timeFrame: at the end of surgery
measure: patient and surgeon satisfaction
timeFrame: assessed on the first postoperative day from both patients and surgeons.
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Heba M EL-Asser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scawn RL, Allen MJ, Rose GE, Verity DH. Randomised, masked study of local anaesthesia administered prior to external dacryocystorhinostomy under general anaesthesia. Eye (Lond). 2019 Mar;33(3):374-379. doi: 10.1038/s41433-018-0201-5. Epub 2018 Sep 18.
citation: Ghali AM, El Btarny AM. The effect on outcome of peribulbar anaesthesia in conjunction with general anesthesia for vitreoretinal surgery. Anaesthesia. 2010 Mar;65(3):249-53. doi: 10.1111/j.1365-2044.2009.06191.x. Epub 2009 Dec 23.