Inguinal HerniorrhaphyNCT03534505
Post-Operative Analgesic Effects of Local Wound Infiltration With Ketorolac After Inguinal Herniorrhaphy
A study testing Ketorolac group and Bupivacaine group in people with Inguinal Herniorrhaphy and Pain, Postoperative, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inguinal Herniorrhaphy, Pain, Postoperative
- What is being tested?
- Ketorolac group and Bupivacaine group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Patients with end stage disease
- Patients who are pregnant
- Patients who reject or withdrawal from research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Double-Blind of 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.
Read the detailed description
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.
- Conditions
- Inguinal Herniorrhaphy, Pain, Postoperative
- Being tested
- Ketorolac group, Bupivacaine group
- Keywords
- Inguinal Herniorrhaphy, Analgesic Effects of Local Wound
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac groupOther
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.
Bupivacaine groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Bupivacaine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Secondary outcomes (1)
Wound hematoma
Abnormal bleeding at surgical wound.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Jul 2018
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: cannot enroll patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniorrhaphyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Ramathibodi Hospital
- Responsible party
- Sponsor
- Investigators
- Chairat Supsamutchai, MD, Study director, 270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400Worasit Chaimongkhalanon, MD, Principal investigator, 270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400Chumpon Wilasrusmee, MD, Principal investigator, 270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534505
- Sponsor's protocol ID
- 2017/456
- Status last verified
- Sep 2021
- First submitted
- 26 Apr 2018
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Double-Blind of Post-Operative Analgesic Effects of Local Wound Infiltration With Ketorolac After Inguinal Herniorrhaphy
- ClinicalTrials.gov ID
- NCT03534505
- Acronym / sponsor ID
- 2017/456
- Conditions
- Inguinal Herniorrhaphy, Pain, Postoperative
- Keywords
- Inguinal Herniorrhaphy, Analgesic Effects of Local Wound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: cannot enroll patient
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Ramathibodi Hospital
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketorolac injections | Experimental | Other: Ketorolac groupPatients 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. |
| bupivacaine | Active comparator | Other: Bupivacaine groupPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac grouppatients 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 injections |
| Bupivacaine grouppatients 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 |
Primary outcome
Effectiveness of Ketorolac injections in term of pain at 4 hours using visual analog scale after herniorrhaphy surgery.
Time frame: 4 hours
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.
1 secondary outcome
Wound hematoma
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: cannot enroll patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chairat Supsamutchai, MD study director
270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400
Worasit Chaimongkhalanon, MD principal investigator
270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400
Chumpon Wilasrusmee, MD principal investigator
270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac group and Bupivacaine group in people with Inguinal Herniorrhaphy and Pain, Postoperative, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: cannot enroll patient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Ketorolac injections in term of pain at 4 hours using visual analog scale after herniorrhaphy surgery. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.