Post-Operative Analgesic Effects of Local Wound Infiltration With Ketorolac After Inguinal Herniorrhaphy
Post-Operative Analgesic Effects of Local Wound Infiltration With Ketorolac After Inguinal Herniorrhaphy
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.
The study design is a prospective randomized, double-blind, controlled trial of patients who
 are undergoing elective unilateral inguinal herniorrhaphy at Ramathibodi Hospital during the
 period 1 July 2018 - 30 June 2020 The primary outcome is to study the effectiveness of
 Ketorolac injections in pain relief after herniorrhaphy surgery and the secondary outcome is
 to study the adverse effects and complications after injection of Ketorolac: anaphylactic
 shock, abnormal bleeding at surgical wound, gastrointestinal bleeding and acute kidney
 injury.

 After approval by the ethics committee, patients scheduled for elective unilateral inguinal
 herniorrhaphy under general anesthesia who are eligible for inclusion criteria will be
 recruited for this study after informed consent by surgical residents or surgical staff at
 the Out Patient Department (OPD). Patients who meet the exclusion criteria will be excluded.

 During a preoperative visit, the patients will be introduced to the concept of the visual
 analogue scale (VAS), which ranges from 0 = no pain to 10 = worst pain.

 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 10 ml. 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.

 A standardized plan for postoperative analgesia is prepared. All patients will receive one
 500 mg tablet of oral paracetamol every 6 hours when postoperative oral intake is allowed by
 the attending doctor. In patients with VAS scores >3, parenteral opioid (Morphine) is given.

 The hospital volunteer nurses caring for the patients during the preoperative and
 postoperative course are given standard pain evaluation protocols. All study pain evaluators
 and patients are blinded to treatment assignments throughout the pain assessment process.

 After the operation, the inpatient ward nurse will record the patients' pain scores at 4,8,
 and 12 hours after surgery using the VAS score and record the results in the study data
 recording form attached to each patient's medical record chart. Additional morphine usage
 data is also recorded.

 All adverse effects and complications after injection of Ketorolac injection such as
 anaphylactic shock, abnormal bleeding at surgical wound, gastrointestinal bleeding and acute
 kidney injury will be recorded and treated by the attending resident or consultant doctor.
 All data is collected by the main investigator from the patient chart and data recording
 form. Data is expressed as mean ± SD. Parametric data is compared between groups. Statistical
 significance is set at a level of p< 0.05.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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