Retrobulbar Block Versus Ketamine Infusion for Post-enucleation Analgesia

Pain, Postoperative Clinical Trial

Official title:

Retrobulbar Block Versus Ketamine Infusion as Adjuvants to General Anesthesia for Post-operative Pain Control After Enucleation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507426
• Other study ID #: RBKIPEA
• Status: Completed
• Phase: N/A
• Start date: April 25, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares the efficacy and safety of two techniques, retrobulbar block versus intra-operative ketamine infusion, for control of post-operative pain occurring in patients undergoing ocular enucleation or evisceration performed under general anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ocular enucleation candidate patients

• Ocular evisceration candidate patients

Exclusion Criteria:

• Any condition contra-indicating general or local anesthesia

• Allergy to any of the drugs used during the procedure

Related Conditions & MeSH terms

• Enucleated; Eye
• Evisceration; Operation Wound
• Pain, Postoperative

Intervention

Procedure:
• Retrobulbar block
Patients will receive a single retrobulbar injection with 3-4ml of an equal mixture of Lidocaine 2% & Bupivacaine 0.5% + Hyaluronidase (10 IU/ml), after induction of general anesthesia.
• Ketamine
Patients will receive a 0.5 mg/kg bolus followed by an infusion of 0.25 mg/kg/h of intravenous Ketamine, after induction of general anesthesia.

Locations

Country	Name	City	State
Egypt	Kasr Al-Ainy Hospital, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nazmy Edward Seif

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the first post-operative rescue analgesia.	Time (measured in minutes) elapsed till the patient requires to receive his first post-operative rescue analgesic dose.	24 hours