Subconjunctival Bupivacaine in Strabismus Surgery

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04782960
• Other study ID #: Subconjunctival bupivacaine
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: May 2021

Study information

• Verified date: March 2021
• Source: Fayoum University
• Contact: Abeer Sh Goda
• Phone: 01005151706
• Email: Asg06[@]fayoum.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Strabismus

Intervention

Drug:
• Iocal anaesthetic bupivacaine
Local anaesthetic Subconjunctival bupivacaine
• Placebo
0.9 saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	Will be evaluated according to satisfaction score (poor=0, fair=1, good=2, excellent=3)	24 hours postoperatively
Other	Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	30 minutes after extubation
Other	Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	60 minutes after extubation
Other	Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	2 hours after extubation
Other	Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	4 hours after extubation
Other	Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	6 hours after extubation
Other	Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	12 hours after extubation
Other	Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	24 hours after extubation
Primary	Visual analog scale (VAS) pain score	Range, 0_10;0,no pain ;10,worst pain	5 minutes after extubation
Secondary	Nausea and vomiting	Operation related side effect	24 hours postoperatively