TITLE: COMPARISON OF POST-OPERATIVE SEROMA FORMATION IN

LICHTENSTEIN MESH HERNIOPLASTY UNDER LOCAL VERSUS SPINAL

ANESTHESIA
INTRODUCTION
Inguinal hernia repair is a common surgical procedure, with a growing number of cases
annually 1. The Lichtenstein mesh technique has emerged as the gold standard for this
surgery, offering distinct benefits over older methods. Traditionally, inguinal hernia repair
2, 3
was performed under spinal anaesthesia or occasionally under general anaesthesia .
However, local infiltrative anaesthesia has gained popularity in recent years, particularly
among adult patients, due to its safety profile, minimal postoperative side effects, and shorter
4, 5
recovery time . Studies have shown that local infiltration anaesthesia effectively blocks
surgical stress, provides prolonged postoperative analgesia, and is simple to administer,
making it safe even for high-risk patients, including elderly and medically unfit individuals.
Lichtenstein mesh repair performed under local anaesthesia has been demonstrated as an
effective day-case procedure, further supporting its suitability for this patient population 6, 7.
According to Dhamudia et al., in a study involving 100 male patients undergoing
Lichtenstein tension-free mesh hernioplasty, the incidence of seroma formation was found to
be 2.4% in the spinal anaesthesia group and 0% in the local anaesthesia group. This suggests
that Lichtenstein tension-free mesh hernioplasty performed under local anaesthesia may
represent a safer alternative compared to spinal anaesthesia 8. In a study conducted by
Maurya et al., which included 80 male patients, it was observed that 10% of patients in the
local anaesthesia (LA) group developed seroma, while 7.5% of patients in the spinal
anaesthesia (SA) group experienced seroma formation 9. In a study by Kale et al. involving
60 cases, it was found that 18.4% of patients in the spinal anaesthesia (SA) group and 19.4%
in the local anaesthesia (LA) group developed seroma 10.
The rationale of the current study is to address the growing need for evidence-based guidance
in selecting the most appropriate anaesthesia method for Lichtenstein mesh hernioplasty,
considering the rising popularity of local infiltrative anaesthesia as an alternative to
traditional spinal anaesthesia. With divergent findings across existing studies regarding the
incidence of postoperative seroma formation between these two anaesthesia techniques, a
comprehensive investigation is imperative to establish a clear comparative understanding.
The findings of this study have the potential to significantly impact surgical practice by
guiding surgeons towards the anesthesia method associated with the lowest risk of seroma
formation, thereby enhancing patient safety, and improving overall surgical success rates.
OBJECTIVE
To compare the incidence of postoperative seroma formation following Lichtenstein mesh
hernioplasty under local anaesthesia versus spinal anaesthesia.
OPERATIONAL DEFINITIONS
Direct Hernia: A direct inguinal hernia is characterized by protrusion of abdominal contents
through the defect in the abdominal wall within Hesselbach's triangle, medial to the inferior
epigastric vessels.
Indirect Hernia: An indirect inguinal hernia occurs when abdominal contents protrude
through the internal inguinal ring, lateral to the inferior epigastric vessels, and may extend
into the inguinal canal and scrotum in males.
Seroma: Seroma will be defined as the accumulation of fluid resulting from the
inflammatory response to the presence of a foreign body.
Recurrence of the hernia: Hernia recurrence will be identified as the reappearance of the
hernia sac through the defect in the abdominal wall.
Infection: Infection will be characterized by the presence of pus or other indicators of
infection (e.g., fever) at the surgical site.
Hospital stay: The duration of hospitalization will be determined as the period from
admission to discharge.
HYPOTHESIS
There is a difference in the incidence of postoperative seroma formation following
Lichtenstein mesh hernioplasty between patients undergoing the procedure under local
anaesthesia and those under spinal anaesthesia.
MATERIAL AND METHODS
Study Design: Randomized Controlled Trial
Study Setting: Department of Surgical Unit 1, Allama Iqbal Memorial Teaching Hospital,
Sialkot
Study Duration: Six months after the approval of the synopsis
Sample Size: The sample size of 41 for this study has been determined using the WHO
sample size calculator, considering an anticipated seroma formation rate of 2.4% in the spinal
8
anesthesia group and 19.4% in the local anesthesia group 10, a significance level set at 5%
and a power of the test at 80%. A total of 82 patients (41 in each group) will be included in
this study.
Sampling Technique: Non-Probability consecutive sampling
Sample Selection:
Inclusion Criteria:
1. Patients aged 18 to 60 years.
2. Male Patients
3. Undergoing Lichtenstein mesh hernioplasty for primary unilateral inguinal hernia.
4. ASA (American Society of Anesthesiology) I and II category cases
Exclusion Criteria:
1. Recurrent inguinal hernia.
2. Contraindications to the use of local and regional anesthetics
3. Patients presenting for emergency inguinal hernia repair, such as incarcerated or
strangulated hernias.
DATA COLLECTION PROCEDURE
After approval from the hospital ethical committee, informed consent will be obtained from
all patients. Basic data, including name, age, laterality of hernia (right/left), type of hernia
(direct/indirect), height, and weight for body mass index (BMI), will be recorded. All 82
patients undergoing Lichtenstein mesh hernioplasty will be randomly assigned into two
groups (41 each) using a lottery method. Group I will undergo spinal anesthesia, and Group II
will receive local anesthesia. Intravenous antibiotics will be administered 30 minutes before
skin incision. Local anesthesia will be administered using a 50:50 mixture of 2% lignocaine
and 0.5% bupivacaine. Spinal anesthesia will be administered according to the
anesthesiologist’s method of choice, preferably through an L3-4 intervertebral midline
approach. Conscious sedation will be provided by the infusion of rapid-acting amnesic and
anxiolytic midazolam at 0.1 mg/kg/hr. All procedures will be conducted by a single
anesthesia team, consisting of two consultants with over five years of experience, following
standard operating procedures. Patients will be discharged once their post-surgical recovery
allows, and they will be instructed to engage in daily, routine, non-strenuous activities after
discharge. The duration of hospital stay will be recorded. A non-steroidal anti-inflammatory
analgesic will be prescribed for five days. Patients will be followed for one month for seroma
formation and any other postoperative complications, such as hernia recurrence, surgical site
infection, scrotal edema, and groin pain, will be noted. All data will be documented on a
predefined proforma.
STATISTICAL DATA ANALYSIS
All data will be entered and analyzed using SPSS version 27.0. Numerical variables such as
age, height, weight, BMI, and duration of hospital stay will be reported as mean and standard
deviation. Categorical variables including laterality of hernia, type of hernia, seroma
formation and post-operative complications will be presented as frequency and percentages.
The association of seroma formation and complications in both groups will be assessed using
the chi-square test, with a significance level set at p ≤ 0.05. Data will be stratified by age,
BMI, laterality, and type of hernia, and post-stratified chi-square tests will also be conducted.
REFERENCES
1. Kamat VV, Chandran A. A comparative study of tension free mesh hernia repair done
under local anaesthesia versus regional anaesthesia. J Evol Med Dent Sci. 2019;8(11):764-9.
2. Jain A, Jain R, ChoUdhRIe A. Local anaesthesia versus spinal anaesthesia in inguinal
hernia surgery-an evidence based approach. Int J Anat Radiol Surg. 2019;8(3):1-4.
3. Chen DC, Morrison J. State of the art: Open mesh-based inguinal hernia repair.
Hernia. 2019;23(3):485-92.
4. Bhardwaj S, Sharma S, Bhardwaj V, Lal R. Comparison of local versus spinal
anaesthesia in inguinal hernia repair. Int Surg J. 2020;7(12):4107-11.
5. Gorsi BA, Bhat SA, Peer JA. Hernioplasty for uncomplicated inguinal hernia done
under local anaesthesia versus spinal anaesthesia. Int J Surg. 2022;6(4):68-73.
6. Olsen JHH, Oberg S, Andresen K, Klausen TW, Rosenberg J. Network meta-analysis
of urinary retention and mortality after lichtenstein repair of inguinal hernia under local,
regional or general anaesthesia. Br J Surg. 2020;107(2):e91-e101.
7. Besra S, Mohanta PK, Mallik C, Hussian NH, Biswas S, Pal S, Roy D. A comparative
study of lichtenstein hernioplasty performed under spinal anaesthesia versus local anaesthesia
in treatment of unilateral inguinal hernia. Int Surg J. 2019;6(10):3773-80.
8. Dhamudia HC, Hembram P, Kandi S, Nayak AK, Pal BC. Lichtenstein tension free
mesh hernioplasty under local anaesthesia versus spinal anaesthesia. Int J Surg Med.
2022;8(3):32-9.
9. Maurya NK, Asif S, Tahir S, Aishwarya K, Shiromani S. To compare the outcome of
inguinal hernia repair under local and spinal anesthesia. Int J Abdom Wall Hernia Surg.
2022;5(3):122-8.
10. Kale R, Anil D. Tension-free inguinal hernia repair in local anaesthesia versus spinal
anaesthesia. Perspect. 2021;9(3):39-43.
PROFORMA
TITLE: COMPARISON OF POST-OPERATIVE SEROMA FORMATION IN
LICHTENSTEIN MESH HERNIOPLASTY UNDER LOCAL VERSUS SPINAL
ANESTHESIA
Serial Number: ________________________
Dated: _______________________
Patient Information:
Name: _______________________________________
Age: _______________________________________ (Years)
Height (cm): __________________________________
Weight (kg): __________________________________
BMI: _______________________________________
Type of hernia: [ ] Direct [ ] Indirect
Laterality of Hernia: [ ] Right [ ] Left
Assigned Group: [ ] Group I (Spinal anesthesia) [ ] Group II (Local anesthesia)
Duration of hospital stay: _________________ days
Post-operative Findings (At one month):
Seroma Formation: [ ] Yes [ ] No
Other Complications
[ ] Recurrence of the hernia
[ ] Surgical site infection
[ ] Scrotal oedema
[ ] Groin pain
[ ] Others ______________