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

Summary

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.

Conditions

• Inguinal Herniorrhaphy
• Pain, Postoperative

Interventions

OTHER

Ketorolac group

patients will undergo herniorrhaphy with Lichtenstein Tension-Free Repair technique. After abdominal sheath will be closed by Vicryl No.0, Patients who are the Ketorolac group will receive local infiltration in abdominal sheath layer with Ketorolac 30 mg in normal saline 10ml. And then skin closure will be done by nylon 3-0.

OTHER

Bupivacaine group

patients will undergo herniorrhaphy with Lichtenstein Tension-Free Repair technique. After abdominal sheath will be closed by Vicryl No.0, Patients who are the Bupivacaine group will receive local infiltration in abdominal sheath layer with 0.5% bupivacaine 10 ml. And then skin closure will be done by nylon 3-0.

Sponsors & Collaborators

• Ramathibodi Hospital

  collaborator OTHER

• Mahidol University

  lead OTHER

Principal Investigators

• Chairat Supsamutchai, MD · 270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400

• Worasit Chaimongkhalanon, MD · 270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400

• Chumpon Wilasrusmee, MD · 270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-01

Primary Completion

2021-09-01

Completion

2021-09-01

Countries

• Thailand

Study Locations