NCT03534505

Post-Operative Analgesic Effects of Local Wound Infiltration With Ketorolac After Inguinal Herniorrhaphy

Terminated NA Last updated 9 September 2021

What this trial tests

NA trial testing Ketorolac group in Inguinal Herniorrhaphy in 10 participants. Terminated before completion.

Timeline

1 July 2018

Primary endpoint
1 September 2021

1 September 2021

Quick facts

Lead sponsor	Mahidol University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	10
Start date	1 July 2018
Primary completion	1 September 2021
Estimated completion	1 September 2021
Sites	1 location across Thailand

Drugs / interventions tested

• Ketorolac group
• Bupivacaine group

Conditions studied

• Inguinal Herniorrhaphy — all drugs for Inguinal Herniorrhaphy →
• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Mahidol University

Who can join

Adults 18 to 75, any sex, with Inguinal Herniorrhaphy or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Inguinal hernia is one of the most common diseases worldwide, including Thailand. Patients who underwent treatment of inguinal hernia (herniorrhaphy) found surgical site pain.There are many procedures to relieve pain after surgery. Injection of pain killer at the surgical site is a well-known method nowadays, especially with NSAIDs; Nowadays, Ketorolac is among the most-often used drug in the research. B. Ben-David's et al. published in 1995. is the study of the effects of the Ketorolac by comparing 60 mg of Ketorolac injected intramuscularly and 30 mg injections at the surgical site in 32 patients who underwent herniorrhaphy. Observing patients after surgery, postoperative pain score at 2 and 6. After 24 hours of surgery, they found that the patients who were given Ketorolac 30 mg suffered less pain than the group of patients who had Ketorolac 60 mg with statistical significant (P\<0.05). The study by Connelly and colleagues, published in 1997, was a randomized double-blind study which compared the performance of relieving pain after surgery of surgical site injection of Ketorolac 60 mg and intravenous injection of Ketorolac 60 mg. In studies of 30 patients with herniorrhaphy surgery, the results showed within 24 hours of surgery, the group of patients with surgical site injections suffered less pain than the group of patients with intravenous injection (P\<0.02). Besides they discovered that the time to first analgesia in the group of patients with surgical site injection was longer. (P\<0.03), and the amount of analgesic requirement that the patients needed in the first 24 hours after surgery was also less in this group. (P\<0.0002). According to the research above surgical site injection of Ketorolac is effective in pain relief. Bupivacaine is the most accepted drug using local infiltratively to relieve the pain especially in patients with herniorrhaphy. Previous studies of Bupivacaine found that Bupivacaine is a very effective in pain reliever, can reduce the usage of opioids, and also can reduce the recovery time in hospital. Thus, our study is to demonstrate the effectiveness of pain relief after surgery by local infiltration of Ketorolac in a patients who undergo herniorrhaphy by dividing patients into two groups and comparing between Ketorolac and Bupivacaine injection at surgical site.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.