Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-10-31

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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketorolac Tromethamine

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

Group Type EXPERIMENTAL

Ketorolac Tromethamine

Intervention Type DRUG

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

scleral buckle

Intervention Type PROCEDURE

Surgical procedure of scleral buckle under retrobulbar block anesthesia

placebo

On operation day, the patients were randomly assigned to receive placebo before scleral buckle surgery.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

On operation day, the patients were randomly assigned to receive placebo 30 min before scleral buckle surgery.

scleral buckle

Intervention Type PROCEDURE

Surgical procedure of scleral buckle under retrobulbar block anesthesia

Interventions

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Ketorolac Tromethamine

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

Intervention Type DRUG

placebo

On operation day, the patients were randomly assigned to receive placebo 30 min before scleral buckle surgery.

Intervention Type DRUG

scleral buckle

Surgical procedure of scleral buckle under retrobulbar block anesthesia

Intervention Type PROCEDURE

Other Intervention Names

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ketorolac disambiguation

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No