Effect of Ultra-Sound Guided Pre-emptive Nerve Block on Post-operative Pain Following Open Inguinal Hernia Repair.

Summary

Participation Requirements

Description

In this study our aim in detail is to: 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 consumption? recovery to work, driving and usual activity) of the US guided nerve block in patients who underwent in...

In this study our aim in detail is to: 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 consumption? 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. Evaluate the advantages of the US guided nerve block in postoperative inguinal hernia repair patients. Demonstrate its compatibly as a one day procedure (less length of hospital stay), with earlier return to work and driving and recovery in general. 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: Patients who underwent elective inguinal hernia repair (will consider the hernia size). Age from 18-70. Their ASA score 1,2 or 3 (American Society of Anesthesia) Operation under general anaesthesia. Open inguinal hernia repair. Exclusion criteria: All emergency inguinal hernia repair and recurrent hernia. Children and pregnant women. Patients having regional anaesthesia. (Spinal/Local). 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.

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