Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Ketorolac Tromethamine; Drug: placebo; Procedure: scleral buckle

• Registration Number: NCT02729285
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients. Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar anesthesia saves operative time and money compared to general analgesia, the intraoperative pain is frequent and a proportion of postoperative pain is often ignored. Ketorolac has been demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy, posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (LASEK), and so forth. The aim of the investigators study is to determine the safety and preemptive analgesic effect of ketorolac in the perioperative pain control of patients undergoing RD surgery under retrobulbar anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2016-03-27
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

1. consent of the patient or legal guardian
2. 18 years or above
3. normal height and weight
4. ASA class I, II
5. elective surgery
6. surgery time within 60min
7. understanding of the verbal numerical rating score (0-10)

Exclusion Criteria

1. history of ocular surgery, trauma or infection
2. intraoperative complications
3. glaucoma or ocular hypertension (> 20 mmHg)
4. diabetic retinopathy
5. diagnosis of asthma or coagulopathy
6. chronic pain syndromes
7. history of peptic ulceration, liver or hematologic disease
8. history of chronic use of analgesics, sedatives, opioids or steroids
9. history of drug or alcohol abuse
10. history of systemic disease
11. sexually transmitted disease (STD)
12. Pregnancy, lactation;
13. cognitive impairment or psychiatric illness;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	scleral buckle	On operation day, the patients were randomly assigned to receive placebo before scleral buckle surgery.
Ketorolac Tromethamine	Ketorolac Tromethamine	On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 minutes before scleral buckle surgery.
Ketorolac Tromethamine	scleral buckle	On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 minutes before scleral buckle surgery.
placebo	placebo	On operation day, the patients were randomly assigned to receive placebo before scleral buckle surgery.

Primary Outcome Measures

Name	Time	Method
Pain score using numerical rating scale (NRS)	at 24 hours postoperatively

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China