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Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

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Sun Yat-sen University

Status and phase

Completed
Phase 4

Conditions

Pain

Treatments

Drug: placebo
Procedure: scleral buckle
Drug: Ketorolac Tromethamine

Study type

Interventional

Funder types

Other

Identifiers

NCT02729285
2014MEKY042

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

73 participants in 2 patient groups, including a placebo group

Ketorolac Tromethamine
Experimental group
Description:
On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 minutes before scleral buckle surgery.
Treatment:
Drug: Ketorolac Tromethamine
Procedure: scleral buckle
placebo
Placebo Comparator group
Description:
On operation day, the patients were randomly assigned to receive placebo before scleral buckle surgery.
Treatment:
Drug: placebo
Procedure: scleral buckle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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