Subconjunctival Bupivacaine in Strabismus Surgery

The Effect of Subconjunctival Bupivacaine Injection in Squint Surgery for Postoperative Analgesia

This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.

Study Overview

• Status: Unknown
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: Iocal anaesthetic bupivacaine; Drug: Placebo

Detailed Description

40 patients will schedule for elective Strabismus surgery under general anaesthesia and randomly allocated into two groups to receive Subconjunctival 0.5%Bupivacaine group(B) or Subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients aged 14 _30 years old with body mass index 18_28kg/m.
• American Anaesthesiologist Association physical states I,II.
• singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia.

Exclusion Criteria:

• were patients with chronic pain.
• ocular hypertension.
• inability to communicate.
• history of hematological disease.
• allergy to local anesthetic drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 20 patients receive Subconjunctival bupivacaine of the end of the surgery; 20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score	Drug: Iocal anaesthetic bupivacaine; Local anaesthetic Subconjunctival bupivacaine; Other Names: Group (p)
Placebo Comparator: 20 patients receive Subconjunctival placebo in the end of operation; 20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score	Drug: Placebo; 0.9 saline; Other Names: Group (s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	5 minutes after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea and vomiting	Operation related side effect	24 hours postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Will be evaluated according to satisfaction score (poor=0, fair=1, good=2, excellent=3)	24 hours postoperatively
Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	30 minutes after extubation
Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	60 minutes after extubation
Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	2 hours after extubation
Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	4 hours after extubation
Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	6 hours after extubation
Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	12 hours after extubation
Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	24 hours after extubation

Collaborators and Investigators

• Sponsor: Fayoum University
• Investigators: Study Director: Mohammad A Hamed, MD, Fayoum University hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Subconjunctival bupivacaine.; Strabismus surgery.; Postoperative analgesia.
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Bupivacaine
• Other Study ID Numbers: Subconjunctival bupivacaine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No