Comparative study between saddle block and local anesthesia on excision of pilonidal sinus by using ligaSure

The excision of the pilonidal sinus starts at 1833. Local, spinal, or general anesthetic procedures for the disease are widely used. The excision of the pilonidal sinus by using ligaSure reduces blood loss, reduces procedure time, and reduces patient length of stay. Therefore, the purpose of this study is to compare between local anesthesia and saddle block on the excision of the pilonidal sinus by using ligaSure, with respect to recovery time, postoperative complications, and patient satisfaction. Forty patients were analyzed; the mean time of anesthesia, operation time, and operating room time were showing highly significantly lower in group LA when compared to group SA (P value < 0.01). At the postoperative period, patients in group LA experienced less intense postoperative pain with prolonged time of the first request for analgesia than patients in other groups. Local anesthesia has more efficacy in early start of anesthesia, early discharge from the hospital with prolonged analgesia, strong hemostasis, more patient satisfaction, and more than saddle block .Therefore, local anesthesia is considered as an alternative to the saddle block on the excision of the pilonidal sinus by using ligaSure.


Rational and background
Pilonidal sinus disease is a painful condition that usually occurs in the intergluteal zone, which carries a high recurrence rate of 37% after surgery (Jones 1992).
It was first described by Mayo in 1833 (Hull and Wu 2002). Since that time, the disease has puzzled the physicians about its etiology, whether congenital or acquired. More than 78,000 troops were treated from this disease during the Second World War, which resulted in less intensive surgical treatment intended to get soldiers out of the hospital and return them to active duty. Therefore, most operations are now conducted as an ambulance (Matter et al. 1995;Ding et al. 2005;Levy and Emery 2003;Sungurtekin et al. 2003;Armstrong and Barcia 1994). Local, spinal, or general anesthetic procedures for the disease are widely used (Sungurtekin et al. 2003).
LigaSure delivers a unique combination of pressure and energy to create a consistent seal with each use. It provides a combination of pressure and energy to create vessel fusion (Ding et al. 2005). Permanently fused vessels include 7 mm in diameter and tissue bundles without dissection or isolation in which the average seal cycle is 2 to 4 s when used with the Force Triad TM energy platform. It reduces blood loss compared to sutures and clips, reduces procedure time compared to sutures, and reduces patient length of stay compared to sutures (Ding et al. 2005;Levy and Emery 2003).
Various health centers apply different techniques of anesthesia without reaching to the best technique of anesthesia (Schmittner et al. 2013). There have been few trials to equate general and local anesthesia for the pilonidal sinus condition in the primary midline closure, and the findings are inconsistent (Sungurtekin et al. 2003;Naja et al. 2003;Kayaalp and Aydin 2009). This study was designed to compare the effect of the local anesthetic and saddle block on the ligaSure excision of the pilonidal sinus (Fig. 1).

Aim of the study
In this context, this study aimed to evaluate and compare local anesthesia with saddle block on the excision of the pilonidal sinus by using ligaSure, with respect to recovery time, postoperative complications, and patient satisfaction.

Patient population and ethical approval
This study was carried out after approval from the hospital ethical committee and obtaining signed informed written consent from the patients between June 2019 and February 2020. This clinical trial was registered in Clinical Trial Registry as a prospective trial.

Anesthetic procedure
Forty patients of both sex, their ages ranged from 20 to 40 years, ASA physical status I and II, scheduled for elective ligaSure excision surgery of the pilonidal sinus were included in this study. They randomized into two groups using a computer-generated randomization table into two groups (LA and SA); each of them included 20 patients: The local anesthesia group( LA) (n = 20) received 20 ml 0.5% bupivacaine plus 10 ml 2% lidocaine infiltrated around the pilonidal sinus in the sacrococcygeal area.
The saddle anesthesia group( SA) (n = 20) received 0.5 % hyperbaric bupivacaine 7.5 mg (1.5 ml) combined with 25ug fentanyl into the subarachnoid space as sacral saddle block where patients were allowed to sit for15 min.

Exclusion criteria included
The exclusion criteria were acute and recurrent pilonidal sinus disease, drug sensitivity, overweight (BMI > 35), diabetes mellitus, heart disease, bleeding, and other underlying diseases.
Pre-operative assessment of the patients included history, clinical examination, and basic investigation. The patient was transferred to the operating room; continued monitoring of HR was performed with ECG and noninvasive monitoring of systolic, diastolic, and MAP using Drager monitor vista 120 Germany, Drager Infinity monitor or vista XL-USA monitor. Oxygen was administrated through a nasal oxygen catheter connected to an anesthetic machine (Drager Primus Germany or Drager Fabius plus, USA). Then the induction of anesthesia was started according to the technique of each group.
Demographic data such as age, sex, height, and weight were reported. The ice cubes were used for the sensory block evaluation (onset, offset) (Table 1). Patient satisfaction was assessed by excellent, good, reasonable, or inadequate (Table 2) and 10 (0 = none, 1-3 = mild, 4-7 = moderate, 8-10 = severe) at the following times: 1st, 4th, and 24th postoperative hour. This scale was explained to the patients preoperatively. The time for the first dose requested of analgesia postoperatively was recorded The primary outcome The primary outcome of the experiment was block onset with respect to sensory and motor blockade (start and duration).

The secondary outcome
Hemodynamic improvements, postoperative analgesia, and readiness for discharge were the secondary outcomes of the study. Total operating time is from the beginning of anesthetic administration to the completion of operation and discharge from the operating room of the patient (Table 3). Operating room time starts from the admission of the patient to the operating room and ends by discharge to recovery (Table 3).Time-to-readiness for discharge (TRD) recoded was defined as the time starting at the end of the surgery and ends when the condition of the patient was confirmed with stable vital signs and oral medication could regulate nausea and pain ( Table 2). The required time-to-first analgesia and patient satisfaction is excellent, good, reasonable, or  (Table 2). Pain severity by visual analog scale (VAS) as in Table 4 was reported as postoperative at 1st, 4th, and 24th hours. Postoperative pain was managed by paracetamol infusion and diclofenac infusion that they were enough ( Table 2).

Methods of randomization
Computer-generated randomization and sealed opaque envelopes, aside from the researchers performing the anesthesia, all other investigators, anesthetist, surgeons, nurses were blinded to the randomization of each subject

Sample size justification
MedCalc® version 12.3.0.0 program "Ostend, Belgium" was used for calculations of sample size, statistical calculator based on 95% confidence interval, and power of the study 80% with α error 5%. According to a previous study, Al-Ghazawi (2004) showed that the mean time on the operating room (min) the in LA group (25 min) compared to the SA group (40 min), with P value < 0.001, is highly significant. So it can be relied upon in this study that based on this assumption, the sample size was calculated according to these values produced by a minimal sample size of 40 cases were enough to find such a difference, subdivide into two groups.

Statistical analysis
Recorded data were analyzed using the statistical package for social sciences, version 20.0 (SPSS Inc., Chicago, IL, USA). Quantitative data were expressed as mean ± standard deviation (SD). Qualitative data were expressed as frequency and percentage.
The following tests were done: Independent sample t test of significance was used when comparing between two means. Mann-Whitney U test: for two-group comparisons in non-parametric data.  Chi-square (x 2 ) test of significance was used in order to compare proportions between qualitative parameters. The confidence interval was set to 95% and the margin of error accepted was set to 5%. So, the P value was considered significant as the following: Probability (P value) P value ≤ 0.05 was considered significant. P value ≤ 0.001 was considered as highly significant. P value > 0.05 was considered insignificant.

Results
There was no statistically significant difference between both groups( P value > 0.05) as regarded age, sex, weight, and patient satisfaction. Twenty patients (15 men and 5 women) were randomly assigned to the LA group, the mean age was 30 (ranged 20-40) years, and the mean weight was 70 (range 45-75) kg, while in the SA group, there are twenty patients (16 men and 4 females), the mean age was 26(ranged 20-35) years, and the mean weight was 65 (ranged 50-70) kg. The patients in the group LA showed highly significantly lower in the operating room time and time of anesthesia than the group SA (P < 0.001). VAS was not significantly different between both groups in the 1st hour postoperative (P value > 0.05), but at 4th and 24th hours postoperative, the patients in the group LA were highly significantly lower compared with group SA (P value < 0.01). Over the first 24 h after surgery, there was high significance prolonged in group LA as compared to group SA (P value < 0.01) as regarding the first request time for analgesia postoperative where there was a decrease in analgesic needs and mean time of discharge in group LA than group SA (P < 0.001).

Disscusion
The optimal treatment for pilonidal sinus disease should be simple, involves short or no hospitalization, and has a low rate of recurrence (Johnson and Villanueva 2001).
Effective pain and wound care should be given, a quick return to normal activity and cost-effective treatment (Jones 1992).
In order to achieve this aim, several surgical and anesthetic procedures are recommended (Naja et al. 2003).
In this analysis, we compare the saddle block with local anesthesia for the use of ligaSure. Local anesthesia and midazolam versus spinal anesthesia are studied in outpatient pilonidal surgery with ligaSure output (Sungurtekin et al. 2003).
In this analysis, the ligaSure procedure makes the local anesthesia more daring than the saddle.
Few studies have been conducted to compare general and local anesthesia for pilonidal sinus disease in primary midline closure, and the results are contradictory (Sungurtekin et al. 2003;Naja et al. 2003;Kayaalp and Aydin 2009).
But in this study, the new method is ligaSure excision of the pilonidal sinus. In many operations, such as hemorrhoidectomy (Tverskoy et al. 1990), ligasure is used successfully. Using ligaSure reduces blood loss compared to sutures and clips (Ding et al. 2005;Levy and Emery 2003), reduces operating time compared to sutures (Ding et al. 2005;Levy and Emery 2003), and decreases patient length compared to sutures (Ding et al. 2005;Levy and Emery 2003).
Another important advantage of using local anesthesia by using ligaSure is less postoperative pain as measured on VAS scale and less postoperative complications including hemorrhage, urinary retention, and wound breakdown, which is close to using ligaSure as in (Tverskoy et al. 1990).

Conclusion
We concluded that local anesthesia can be used as a good alternative to the saddle anesthesia block on the excision of the pilonidal sinus by using ligaSure for its efficacy in early start of anesthesia, early discharge from the hospital with prolonged analgesia, strong hemostasis, and more patient satisfaction.

Limitations and recommendations
Limitations of this study include the use of various functional measures, a limited long-term follow-up, and limited publications about pilonidal excision by using ligaSure to compare with them. Further studies on pilonidal excision by ligaSure are required.