Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

Pain Clinical Trial

Official title:

Preoperative Ketorolac for Intraoperative and Postoperative Pain Management in Scleral Buckling Surgery Under Retrobulbar Block Anesthesia: A Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729285
• Other study ID #: 2014MEKY042
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2016
• Last updated: September 20, 2016
• Start date: July 2014
• Est. completion date: October 2014

Study information

• Verified date: September 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ketorolac Tromethamine
On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 min before scleral buckle surgery.
• placebo
On operation day, the patients were randomly assigned to receive placebo 30 min before scleral buckle surgery.

Procedure:
• scleral buckle
Surgical procedure of scleral buckle under retrobulbar block anesthesia

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score using numerical rating scale (NRS)		preoperative	Yes
Primary	Pain score using numerical rating scale (NRS)	any pain during the whole operation time	intraoperative	Yes
Primary	Pain score using numerical rating scale (NRS)		immediately after operation	Yes
Primary	Pain score using numerical rating scale (NRS)		at 4 hours postoperatively	Yes
Primary	Pain score using numerical rating scale (NRS)		at 24 hours postoperatively	Yes