Effect of Ultra-Sound Guided Pre-emptive Nerve Block on Post-operative Pain Following Open Inguinal Hernia Repair.
1 other identifier
interventional
136
0 countries
N/A
Brief Summary
A hernia occurs when an organ 'like intestines' or fatty tissue protrude through a weak point in muscle or connective tissue and one of the most common types of hernia is inguinal. Inguinal hernia defined as a bulge in the inguinal region or scrotum, may be accompanied by dull or burning pain, which worsens by exercise or cough. There are 2 types of inguinal hernia: direct and indirect. Direct inguinal hernia occurs because of a defect or weakness in the transversalis fascia area of the Hesselbach triangle. On the other hand, the indirect inguinal hernia which is the most common inguinal hernia follows the tract of inguinal canal and result from a persistent processus vaginalis. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 10, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2023
CompletedNovember 2, 2021
October 1, 2021
1.1 years
February 9, 2021
October 31, 2021
Conditions
Outcome Measures
Primary Outcomes (20)
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Day 1 postoperative.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Day 2 postoperative.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Day 3 postoperative.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Day 4 postoperative.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Day 30 postoperative.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
3 month postoperative for chronic pain.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
6 month postoperative for chronic pain.
Assessment of early mobilisation.
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Day 1 postoperative period.
Assessment of early mobilisation.
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Day 2 postoperative period.
Assessment of early mobilisation.
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Day 3 postoperative period.
Retain to driving (how many days between surgery and patient back to dive)
When the patient back to drive his car? assessed by monitoring the patients postoperative and record when he started to drive the car again.
Postoperative period up to 8 weeks.
Retain to work (how many days between surgery and patient back to his work)
When the patient back to his work or usual activity? assessed by monitoring the patients postoperative and record when he started to work again.
Postoperative period up to 8 weeks.
Length of hospital stay (in days).
Length of hospital stay post open inguinal hernia repair ( how many days patient spend in the hospital postoperative).
immediately after the surgery until patient discharged.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Day 1 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Day 2 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Day 3 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Day 4 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Day 5 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Day 6 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Day 7 postoperative.
Study Arms (2)
The experimental group will receive US guided nerve block
EXPERIMENTALThe experimental group will receive US guided nerve block by lidocaine before open inguinal hernia repair.
The control group will receive usual infiltration
OTHERThe control group will receive usual infiltration by lidocaine before open inguinal hernia repair.
Interventions
Ultra sound guided nerve block by lidocaine before open inguinal hernia repair.
Usual infiltration by lidocaine before open inguinal hernia repair.
Eligibility Criteria
You may qualify if:
- Patients who underwent elective inguinal hernia repair (will consider the hernia size).
- Age from 18-70. (70 with no other comorbiditeis)
- Their ASA score 1,2 or 3 (American Society of Anesthesia)
- General Anesthesia.
- Open inguinal hernia repair.
You may not qualify if:
- All emergency inguinal hernia repair and recurrent hernia.
- Children and pregnant women.
- Patients having regional anesthesia. (Spinal/Local).
- Laparoscopic inguinal hernia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double blinded ( Patient and researcher recruiter)
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of General Surgery in Imam Abdulrahman bin Faisal University
Study Record Dates
First Submitted
February 9, 2021
First Posted
March 10, 2021
Study Start
December 1, 2021
Primary Completion
December 29, 2022
Study Completion
June 29, 2023
Last Updated
November 2, 2021
Record last verified: 2021-10