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

NCT03534505 | Terminated

• 1 other identifier: 2017/456
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Inguinal Herniorrhaphy; Analgesic Effects of Local Wound

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Ketorolac injections in term of pain at 4 hours using visual analog scale after herniorrhaphy surgery.

  Effectiveness of Ketorolac injections in term of pain using visual analog scale after herniorrhaphy surgery. The concept of the visual analogue scale (VAS), which ranges from minimum score as 0 = no pain and maximum pain score as 10 = worst pain. After the herniorrhaphy surgery, the patients will be record pain score by visual analog scale at 4 hours after herniorrhaphy surgery. For patients who have more than 3 point of pain score, parenteral opioid will be perform.

  4 hours

Secondary Outcomes (1)

• Wound hematoma

  24 hours

Study Arms (2)

Ketorolac injections

EXPERIMENTAL

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: Ketorolac group

bupivacaine

ACTIVE COMPARATOR

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.

Other: Bupivacaine group

Interventions

Ketorolac group OTHER

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.

Ketorolac injections

Bupivacaine group OTHER

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.

bupivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 75 years old undergoing elective unilateral inguinal herniorrhaphy at Ramathibodi hospital
• Patients who are ASA classification 1-2
• Patients who had normal liver function test : AST 5-34 U/L , ALT 0-55 U/L, ALP 40-150 U/L ,TB0.2-1.2 mg/dL ,DB 0.0-0.5 mg/dL
• Patients who are going the operation under general anesthesia
• Patients who undergoing herniorrhaphy with Lichtenstein Tension-Free Repair technique

You may not qualify if:

• Patients who had femoral hernia
• Patients who had history of NSAIDs allergy
• Patients with history of prior hernorrhaphy
• Patients who had history of GI bleeding and gastritis
• Patients who had infection
• Patients who had history of SLE, HIV, asthma , cardiovascular disease and chronic kidney disease(GFR\<60 ml/min/1.73m2)
• Patients with end stage disease
• Patients who are pregnant
• Patients who reject or withdrawal from research

Sponsors & Collaborators

• Mahidol University: lead
• Ramathibodi Hospital: collaborator

Study Sites (1)

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Chairat Supsamutchai, MD

  270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400

  STUDY DIRECTOR

• Worasit Chaimongkhalanon, MD

  270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400

  PRINCIPAL INVESTIGATOR

• Chumpon Wilasrusmee, MD

  270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Once given general anesthesia in the operating room, the patient will be randomly selected into one of the two arms of this report's diagram (1:1 ratio) through the drawing of a sealed, opaque envelope by one of the surgical residents in charge or by the attending surgeon. All 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 patients who are the control group will receive local infiltration with 0.5% bupivacaine 10 ml. And then skin closure will be done by nylon 3-0.

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 23, 2018
• Study Start: July 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)