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Completed

NCT Number: NCT02729285

Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Ketorolac Tromethamine

Drug

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

Other names: ketorolac

Placebo

Drug

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

Other names: disambiguation

scleral buckle

Procedure

Surgical procedure of scleral buckle under retrobulbar block anesthesia

Primary outcomes

  1. Pain score using numerical rating scale (NRS)

    Time frame: preoperative

  2. Pain score using numerical rating scale (NRS)

    Time frame: intraoperative

    any pain during the whole operation time

  3. Pain score using numerical rating scale (NRS)

    Time frame: immediately after operation

  4. Pain score using numerical rating scale (NRS)

    Time frame: at 4 hours postoperatively

  5. Pain score using numerical rating scale (NRS)

    Time frame: at 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 6, 2016
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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