Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Ketorolac Tromethamine
* Drug: placebo
* Procedure: scleral buckle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: consent of the patient or legal guardian 18 years or above normal height and weight ASA class I, II elective surgery surgery time within 60min understanding of the verbal numerical rating score (0-10) Exclusion Criteria: history of ocular surgery, trauma or infection intraoperative complications glaucoma or ocular hypertension (> 20 mmHg) diabetic retinopathy diagnosis of asthma or coagulopathy chronic pain syndromes history of peptic ulceration, liver or hematologic disease history of chronic use of analgesics, sedatives, opioids or steroids history of drug or alcohol abuse history of systemic disease sexually transmitted disease (STD) Pregnancy, lactation; cognitive impairment or psychiatric illness;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |