NCT02729285

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

March 27, 2016

Last Update Submit

September 20, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Ketorolac Tromethamine

EXPERIMENTAL

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

Drug: Ketorolac TromethamineProcedure: scleral buckle

placebo

PLACEBO COMPARATOR

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

Drug: placeboProcedure: scleral buckle

Interventions

Ketorolac TromethamineDRUG

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

Also known as: ketorolac
Ketorolac Tromethamine
placeboDRUG

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

Also known as: disambiguation
placebo
scleral bucklePROCEDURE

Surgical procedure of scleral buckle under retrobulbar block anesthesia

Ketorolac Tromethamineplacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • consent of the patient or legal guardian
  • 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)

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • 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.

    PMID: 28770108DERIVED

MeSH Terms

Conditions

Pain

Interventions

Ketorolac TromethamineKetorolacScleral Buckling

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Lu Lin

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Fundus Disease Center of Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

March 27, 2016

First Posted

April 6, 2016

Study Start

July 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

CN(1)