Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ketorolac Tromethamine; Procedure: scleral buckle; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketorolac Tromethamine; On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 minutes before scleral buckle surgery.	Drug: Ketorolac Tromethamine; On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 min before scleral buckle surgery.; Other Names: ketorolac; Procedure: scleral buckle; Surgical procedure of scleral buckle under retrobulbar block anesthesia
Placebo Comparator: placebo; On operation day, the patients were randomly assigned to receive placebo before scleral buckle surgery.	Procedure: scleral buckle; Surgical procedure of scleral buckle under retrobulbar block anesthesia; Drug: placebo; On operation day, the patients were randomly assigned to receive placebo 30 min before scleral buckle surgery.; Other Names: disambiguation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score using numerical rating scale (NRS)		preoperative
Pain score using numerical rating scale (NRS)	any pain during the whole operation time	intraoperative
Pain score using numerical rating scale (NRS)		immediately after operation
Pain score using numerical rating scale (NRS)		at 4 hours postoperatively
Pain score using numerical rating scale (NRS)		at 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Lu Lin, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• Chen X, Liu B, Liang X, Li J, Li T, Li Y, Yu X, Lyu C, Zhao X, Tanumiharjo S, Jin C, Lu L. The Combination of Ketorolac with Local Anesthesia for Pain Control in Day Care Retinal Detachment Surgery: A Randomized Controlled Trial. J Ophthalmol. 2017;2017:3464693. doi: 10.1155/2017/3464693. Epub 2017 Jul 9.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 27, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ketorolac Tromethamine
• Other Study ID Numbers: 2014MEKY042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided