Clinical trial NCT02729285: Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery
Official title: Preoperative Ketorolac for Intraoperative and Postoperative Pain Management in Scleral Buckling Surgery Under Retrobulbar Block Anesthesia: A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Pain score using numerical rating scale (NRS)
timeFrame: preoperative
measure: Pain score using numerical rating scale (NRS)
timeFrame: intraoperative
measure: Pain score using numerical rating scale (NRS)
timeFrame: immediately after operation
measure: Pain score using numerical rating scale (NRS)
timeFrame: at 4 hours postoperatively
measure: Pain score using numerical rating scale (NRS)
timeFrame: at 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Lu Lin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.