Effect of Ultra-Sound Guided Pre-emptive Nerve Block on Post-operative Pain Following Open Inguinal Hernia Repair.
NCT ID: NCT04792164
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
136 participants
INTERVENTIONAL
2021-12-01
2023-06-29
Brief Summary
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Immediate pain after inguinal herniorrhaphy delays the ambulation which leads to delay in the hospital discharge. Besides that, is the chronic pain that affect 50% of patients which is an important issue that needs to be dealt with.
Our aim of this study, is to compare between postoperative period in the patients who received US guided nerve block and in patients who received infiltration only before open inguinal hernia repair, and to show that pre-emptive local anaesthesia will result in better pain control, less postoperative complication, earlier mobilisation, earlier recovery and less analgesia consumption by patients.
Detailed Description
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1. Asses the outcomes (early postoperative pain management in day case "day 1,2,3, 30 and 3 month and 6 month" , length of hospital stay, analgesia consumptionŲ recovery to work, driving and usual activity) of the US guided nerve block in patients who underwent inguinal hernia repair comparing to patient who received only skin infiltration.
2. Evaluate the advantages of the US guided nerve block in postoperative inguinal hernia repair patients.
3. Demonstrate its compatibly as a one day procedure (less length of hospital stay), with earlier return to work and driving and recovery in general.
4. Compare our result with other international studies result.
Study in details:
it is Randomised Control Trial, Double blinded (patients and recruiter), study will be conducted in King Fahd University Hospital, Khobar, Eastern Province, Saudi Arabia. It contains 2 Arms ,Two Parallel groups. The experimental group will receive US guided nerve block and the control group will receive usual infiltration. Lidocaine+ Marcaine will be used in both group with same concentration (1%+.25%). The random allocation will be done using simple random allocation with a help of the following software (random.org).
Will compare the two groups regarding, a questionary with visual analogue will be distributed and data will be collected by recruiters regarding pain scale, length of hospital stay, return to work, return to driving and usual activity, and analgesia consumption post operative, all in day 1,2,3,4,30,3 month and 6 month post operatives (details in outcome section).
We are expecting to have a reduction in pain score from severe to moderate, about 20% in experimental group, and reducing the length of hospital stay from 1-2 days to one day procedure. And reduction in consumption of Analgesia postoperative.
our sample size will be 134 with a power of 80% and an effect size of 0.5, will include all patients who will have inguinal hernia repair and meet our inclusion criteria, in period of 12-18 months starting after obtaining of IRB approval.
* Inclusion criteria:
1. Patients who underwent elective inguinal hernia repair (will consider the hernia size).
2. Age from 18-70.
3. Their ASA score 1,2 or 3 (American Society of Anesthesia)
4. Operation under general anaesthesia.
5. Open inguinal hernia repair.
* Exclusion criteria:
1. All emergency inguinal hernia repair and recurrent hernia.
2. Children and pregnant women.
3. Patients having regional anaesthesia. (Spinal/Local).
4. Laparoscopic inguinal hernia.
Data Management and analysis plan:
* SPSS latest version will be used for data analysis.
* Summary statistic will be obtained as frequency, and percentage for qualitative data, and means, medians and standard deviations from continuous variables.
* Analysis will be done by epidemiologist and biostatistician.
Ethical Considerations:
* Our study does not have any physical, psychological, social, legal, economic risk.
* The study will be reviewed by IRB, ethics committee; then the approval will be obtained.
* Written approval will be obtained from the patients prior to the procedure.
* Preemptive analgesia and infiltration are usually used in our practice and aim to compare.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Arm1) The experimental group will receive US guided nerve block by Lidocaine+Marcaine concentration (1%+.25%).
Arm2) The control group will receive usual infiltration by Lidocaine+Marcaine concentration (1%+.25%).
SUPPORTIVE_CARE
DOUBLE
Study Groups
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The experimental group will receive US guided nerve block
The experimental group will receive US guided nerve block by lidocaine before open inguinal hernia repair.
Ultra sound guided nerve block
Ultra sound guided nerve block by lidocaine before open inguinal hernia repair.
The control group will receive usual infiltration
The control group will receive usual infiltration by lidocaine before open inguinal hernia repair.
Usual infiltration
Usual infiltration by lidocaine before open inguinal hernia repair.
Interventions
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Ultra sound guided nerve block
Ultra sound guided nerve block by lidocaine before open inguinal hernia repair.
Usual infiltration
Usual infiltration by lidocaine before open inguinal hernia repair.
Eligibility Criteria
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Inclusion Criteria
2. Age from 18-70. (70 with no other comorbiditeis)
3. Their ASA score 1,2 or 3 (American Society of Anesthesia)
4. General Anesthesia.
5. Open inguinal hernia repair.
Exclusion Criteria
2. Children and pregnant women.
3. Patients having regional anesthesia. (Spinal/Local).
4. Laparoscopic inguinal hernia.
18 Years
70 Years
ALL
No
Sponsors
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Imam Abdulrahman Bin Faisal University
OTHER
Responsible Party
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Nasser Mohamed Amer
Assistant professor of General Surgery in Imam Abdulrahman bin Faisal University
Central Contacts
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Other Identifiers
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USG-PENB-IHR
Identifier Type: -
Identifier Source: org_study_id