Abstract
Introduction
Despite knowing, that tourniquet induces ischemia and soft tissue damage surgeons still use it. The purpose of this study is to compare post operative pain and quadriceps function in patients undergoing arthroscopy assisted ACL reconstruction with tourniquet and without tourniquet.
Methods
A blinded randomized prospective trial conducted at Orthopaedic department of a tertiary institute in India from Feb 2019 to June 2019. 45 patients undergoing Arthroscopic ACL reconstruction aged between 18 and 60 years were recruited in the study according to selection criteria. Patients were distributed in 2 groups randomly, namely, tourniquet and non-tourniquet. Preoperatively serum CPK measurement and thigh girth measurement was done. Following standard arthroscopic procedure VAS score monitoring for pain was done for 5 days. Serum CPK levels were performed on postoperative day 1. Thigh girth was measured on postoperative day 21.
Result
Pain was significantly high in patients in whom tourniquet was used. VAS scores were significantly high in tourniquet group. Tourniquet group patients required more amount of additional analgesics in postoperative period (p < 0.001). Serum CPK levels were comparable preoperatively while significantly high postoperatively in tourniquet group (p < 0.001). Difference in mean of thigh girth was significant between the groups (p < 0.001) and there is difficulty experienced by patients in performing straight leg raise test after tourniquet use (p = 0.002).
Conclusion
Tourniquet use is associated with increased pain, analgesic requirement, damage to muscles and compromises muscle function in early postoperative period. This can not only lead to increased patient discomfort but also difficult initial rehabilitation. Arthroscopic procedures can be uneventfully performed without the use of a tourniquet, and alternative methods should be looked upon and emphasized.
Keywords: ACL, Arthroscopy, Tourniquet
Introduction
The context of minimally invasive surgeries and arthroscopy is increasing day by day, and tourniquets are used in these surgeries with virtue of decreasing the bleeding and in view of better visibility of tissues. The term ‘tourniquet’ was coined by Jean Louis Petit [1]. It is derived from a French word ‘tourner’ which means “to turn” [2]. These were narrow straps made of bronze, using leather for comfort. Pneumatic tourniquet was first introduced by Harvey Cushing, in 1904 [3] and now it is routinely used in extremity surgeries. However, its use is almost free of complications at present due to précised and titrated pressure but the overall burden of complications of tourniquet use is increasing with its increasing use [4–6]. Complications could be in the form of delay axonal conduction which leads to increase in postoperative pain, also there are increased incidence of early infection and wound healing disorders due to peri-operative hypoxia and reduced post-operative tissue perfusion [7, 8]. Prolonged thigh compression by a pneumatic tourniquet in these procedures has been associated with systemic complications (i.e. lactic acidosis, reperfusion injury, cardiovascular complication) muscular and vascular injuries, and nerve ischemia [9, 10].
Accelerated rehabilitation remains the challenge in sports medicine and efforts are being made to reduce the surgical trauma to patients. Surgeons use tourniquet in arthroscopy surgery to reduce the surgical time and improve the view. Is it wise to inflate the tourniquet in every case, while we have other options to improve the arthroscopic view as there are chances of tourniquet complications, discomfort and muscle damage and probable effect on rehabilitation [8–11]. Here we have prospectively studied impact of tourniquet use on post operative pain and quadriceps function in patients undergoing arthroscopy assisted ACL reconstruction with tourniquet and without tourniquet.
Methodology
All the study subjects were chosen from casualty and orthopedic OPD at a tertiary institute of India from Feb 2019 to June 2019 with complete anterior cruciate ligament rupture with instability of the knee, which required anterior cruciate ligament reconstruction. Patients were initially evaluated by an orthopaedic surgeon, who established the indication for surgery. All patients more than 18 years without any history of previous injury to knee, associated lumbar radiculopathy or ischemic limb diseases and any evidence of simultaneous fractures or osteoarthritis knee (clinico-radiologically), were invited to participate in the trial. All patients received verbal and written information about the trial and a standardized consent form was completed in accordance with the information sheet and consent form approved by the ethics committee. Patients declining to participate in the trial received standard surgery (tourniquet-assisted ACL reconstruction). For the sample size calculation, we expected that there would be a difference of 1 in post-operative pain between two groups. Using a two tailed alpha value (0.05) and power 90%, sample size of 21 patients per group was found to be sufficient to detect a significant difference of an effective size of 1.0
Ethical clearance was approved for our study from the institutional review board(IRB) on 01/08/2018 with certificate number EC/07/18/1383. This study is registered under CTRI with registration number CTRI/2019/02/017542 on 7th February 2019.
Randomization and Allocation Concealment
The randomization sequence was generated using randomization command in Microsoft Word Office 2007. During this period 45 patients were allocated one of two treatment categories by a sequence of letters: A—referring to tourniquet assisted (n = 23) and B—referring to non-tourniquet assisted (n = 22) ACL reconstruction using sequentially numbered, opaque, sealed envelopes. The allocation sequence and preparation of the concealed envelopes was completed by a third person (Medical Records -MR) not involved in the conduct of the trial. The allocation sequence was concealed from the participants, surgeon and statistician. Regardless of group allocation, envelopes were opened immediately prior to the surgical intervention in absence of surgeon. To prevent subversion of the allocation sequence, name of the participant was written on the envelope immediately after randomization by the MR.
Preoperative serum CPK levels were performed and thigh girth measurement, 10 cm. proximal to medial knee joint line with non-stretchable tape was done. Patients were demonstrated to actively raise the leg straight in supine position and were trained to administer VAS score in preoperative period. The entire surgical procedure was performed under spinal anaesthesia with a typical duration of 60–120 min and all patients, regardless of length of surgery, were included in the trial population. Prior to surgery, knee was insufflated with lignocaine and adrenaline injection (20 ml in 1/100,000 conc.) for 10 min to decrease bleeding in every case (Fig. 1) and tourniquet was inflated at a pressure, systolic blood pressure in mm of Hg + 150 mm of Hg in absence of surgeon. All patients underwent standard arthroscopic procedure (Arthroscopic assessment and management of meniscal lesion followed by reconstruction of anterior cruciate ligament with trans tibial tunnelling and fixing the quadrupled semitendinosus graft with 6.5 mm washer on lateral aspect of thigh and on tibial side with the help of screw post.). There was a provision of tourniquet deflation for 15 min if tourniquet time exceeds 120 min; however, it was not needed in any case. Tourniquet deflation was done in absence of surgeon. The post-surgery pain management consisted of Inj. Voveran (75 mg) 8 hourly and Inj. Tramadol (100 mg) 8 hourly, both in 100 ml NS IV, on first day. Tab. Voveran 75 mg (twice daily) was prescribed on discharge for next 5 days. A single surgeon, trained in surgery with and without the use of a tourniquet, performed the surgical procedure. Dividing the patients into 2 Group A: The tourniquet assisted group & Group B: The non-tourniquet assisted group (Fig. 1). Duration of hospital stay was typically 2 days. Serum CPK levels were sent on post-operative day 1. Patients were discharged with crutches or walker aided non weight bearing ambulation. Pain scores (VAS) of post-operative day 1 to day 4 were collected and thigh girth was measured on day 21 in the regular follow-up. A Pre Opeartive and Post Operative xray was done to look for the graft position and implant adequacy (Fig. 2).
Fig. 1.
Left—blood in arthroscopic view while operating without tourniquet; right—clear bloodless arthroscopic view with tourniquet) and insufflated knee following local anaesthnetic injection
Fig. 2.
Pre operative and post operative xray showing graft position with implants
Statistical Methodology
The statistical analysis was done using SPSS package.
Results
A total of 45 patients were included in our study with following demographic and clinical details (Table 1) Average pain scores were calculated for each group and compared with help of t test. Pain scores of patients in tourniquet group were significantly high (Table 2) (Fig. 3). Also average pain scores were calculated for each group and compared with the help of t test at 8 AM and 8 PM post operatively at days 1,2,3 and 4 and were found significantly different between two groups (Table 3, Fig. 4). Requirement of additional analgesia post operatively was significant for tourniquet group (Fig. 5). Difference of average thigh girth (average preoperative thigh girth and average thigh girth at day 21) and Difference of mean serum CPK levels was found significant with p value of < 0.001 for non-tourniquet group (Table 4, Fig. 6) and so was the ability to perform active SLR on day 1 was significant for non-tourniquet group. (Table 5, Fig. 7).
Table 1.
Patient demographics and clinical finding
| Tourniquet group | Non-tourniquet group | |
|---|---|---|
| N | 23 | 22 |
| Age (Mean ± SD) | 29.30 ± 11.06 | 29.64 ± 10.95 |
| Sex (M:F) | 21:2 | 17:5 |
| Meniscus tear (medial/lateral/both) | 8/2/1 | 8/2/3 |
| Mean preop systolic blood pressure (Mean ± SD in mm of Hg) | 143.22 ± 17.22 | 143.18 ± 14.10 |
| Tourniquet duration | 76.48 ± 8.71 | 0 |
Table 2.
Mean VAS score of patients on the day of surgery in both groups
| VAS Score (postoperative day 0) | Tourniquet | Non-tourniquet | p value |
|---|---|---|---|
| Mean ± SD | Mean ± SD | ||
| At 4 h | 7.39 ± 1.469 | 6.09 ± 1.509 | 0.005 |
| At 10 h | 8.04 ± 0.976 | 5.95 ± 1.527 | < 0.001 |
| At 16 h | 7.39 ± 1.270 | 5.14 ± 1.125 | < 0.001 |
| At 22 h | 5.65 ± 0.982 | 4.59 ± 1.054 | 0.001 |
Fig. 3.
Line diagram representing trends of mean pain score in both group on the day of surgery
Table 3.
Mean VAS score of patients on postoperative days 1, 2, 3 and 4 in both groups
| Tourniquet | Non-tourniquet | p value | |
|---|---|---|---|
| Mean ± SD | Mean ± SD | ||
| VAS Score (postoperative day 1) | |||
| At 8 AM | 4.78 ± 0.998 | 3.59 ± 1.221 | 0.001 |
| At 8 PM | 3.57 ± 0.728 | 2.77 ± 1.343 | 0.017 |
| VAS Score (postoperative day 2) | |||
| At 8 AM | 2.65 ± 1.027 | 2.23 ± 1.193 | 0.207 |
| At 8 PM | 2.04 ± 0.928 | 1.77 ± 0.813 | 0.305 |
| VAS Score (postoperative day 3) | |||
| At 8 AM | 1.52 ± 0.898 | 1.09 ± 1.192 | 0.177 |
| At 8 PM | 1.13 ± 0.968 | 0.91 ± 0.921 | 0.437 |
| VAS Score (postoperative day 4) | |||
| At 8 AM | 0.35 ± 0.487 | 0.36 ± 0.658 | 0.927 |
| At 8 PM | 0.30 ± 0.635 | 0.05 ± 0.213 | 0.076 |
Fig. 4.
Line diagram representing trends of mean pain score in both groups on post operative day 1, 2, 3 and 4
Fig. 5.
Bar diagram representing additional requirement of analgesia by the patients
Table 4.
Difference in mean thigh girth and diggerence of mean CPK level of both groups
| Tourniquet | Non-tourniquet | p value | |
|---|---|---|---|
| Mean ± SD | Mean ± SD | ||
| Difference of mean thigh girth | 2.53 ± 0.83 | 1.41 ± 0.58 | < 0.001 |
| Difference of mean CPK (pre-post) | 339.52 ± 62.85 | 103.45 ± 24.13 | < 0.001 |
Fig. 6.
Bar diagram depicting average serum cpk levels of patients at 2 occasions
Table 5.
Performance of active SLR by the patients postoperatively
| Performance of SLR | Tourniquet | Non-tourniquet | p value | ||
|---|---|---|---|---|---|
| Frequency | % | Frequency | % | ||
| Yes | 8 | 34.8 | 18 | 81.8 | 0.002 |
| No | 15 | 65.2 | 4 | 18.2 | |
| Total | 23 | 100 | 22 | 100 | |
Fig. 7.
Bar diagram showing ability to perform active slr by patients of each groups
Discussion
Use of a pneumatic tourniquet is considered a routine surgical adjunct in lower extremity procedures. However, several basic science studies implicate tourniquet ischemia as adversely affecting muscle and nerve function. Most of the previously published studies concerning tourniquet use in arthroscopic knee surgery have focused on its effects after meniscectomy. There has been little evaluation of the role of the tourniquet in functional recovery after arthroscopic ACL reconstruction. The postsurgical rehabilitation after ACL reconstruction has shifted to one that emphasizes early full range of motion, progressive weight bearing, earlier strengthening programs, and even earlier return to sports activity. Many aspects of surgical treatment have been investigated for their effects on the ultimate result. Timing of surgery, associated injuries and their treatments, graft source (patellar tendon versus hamstring tendon), type of approach (open versus two incision, arthroscopically assisted versus one-incision endoscopic), as well as the postoperative rehabilitation program have all been studied as to their effects on recovery and eventual outcome. Tourniquet-related pain is a common occurrence for patients undergoing limb surgeries. Many strategies have been used preoperatively to decrease the incidence of tourniquet- related pain; however, few studies have found effective ways to treat tourniquet related pain postoperatively. Risk factors for postoperative tourniquet-related pain include tourniquet pressure, tourniquet time > 30 min, and tourniquet width. In neither group was the procedure abandoned due to technical difficulties. In Group I, the tourniquet was inflated for an average of 76.48 ± 8.71 min, with an average pressure of 293.22 ± 17.22 mm Hg.
45 patients were included in our study with 23 patients in tourniquet group and 22 patients in non-tourniquet group. The gender wise distribution was comparable for both the groups. Male patients were dominant in each group. Age and sex distribution was found comparable in other studies [12].Meniscal injuries are commonly associated with ACL tear. In our study 16 patients had medial meniscus tear, 4 had lateral meniscus tear and 4 had both meniscus tear.
In our study we compared VAS for pain four times on postoperative day and two times on subsequent 4 days. Difference in VAS for pain was significant on post-op days 0 and 1. Pain scores were comparable on post-operative days 2, 3 and 4. Worland RL et al. studied early post operative thigh pain in patients undergoing TKA. In their prospective trial they found increased complaint of thigh pain on post-op days 0 to 3 in the group of patients, in whom tourniquet was inflated to higher pressure(350 mm of hg) as compare to the group in which tourniquet pressure was kept at lower level (systolic blood pressure + 100 mm hg) [13]. Tibrewal SB observed relatively less pain scores (VAS) in patients undergoing arthroscopic surgeries without tourniquet with mean operative time of 35 min with average postoperative pain score in group A (tourniquet) being 4.5 and in group B (non-tourniquet) being 3.58 [14]. In a study by Furia and Zambetti mean pain medication consumption on postoperative day 1 for the tourniquet group and non-tourniquet group were 4.0 and 3.1, respectively. The total postoperative pain medication consumption scores were 12.1 for the tourniquet group and 10.2 for the non-tourniquet group significant difference which was comparable to our study which also showed that the difference was significant between both the groups in terms of analgesic requirement post operatively with lesser requirement for non-tourniquet group [15].
In a study by Reda et al. he found significant difference in calf and thigh girth diameters at 2 weeks postoperatively between the two groups (p = 0.001) [16]. Arciero et al. noticed strong trend toward denervation in the tourniquet group as he found decreased thigh girth index in tourniquet group 10 cm above the joint line (p = 0.07) [12]. Daniel DM et al. also found significant decrement in thigh girth in tourniquet group patients as compare to non-tourniquet group at 6 weeks and 12 weeks after surgery but found no difference 52 weeks after surgery and also noticed significantly reduced quadriceps strength recovery in tourniquet group at 12 weeks post surgery as compare to non-tourniquet group [17]. Similarly in our study there was significant Difference of average thigh girth At day 21 for tourniquet group compared to non compared group.
In our study, there was significant difference with greater number of cases from non-tourniquet group able to perform straight leg raise test post operatively day 1 when compared to other group. We didn’t find previous literature regarding straight leg raise test performance in postoperative period in patients undergoing arthroscopic ACL reconstruction; however, EMG performed in early postop and at 1 month in study done by Arciero et al. [12] shows that higher patients in tourniquet group demonstrated positive EMG findings at 1 month after surgery compared with non-tourniquet group. They did not attempt to measure strength at this time after surgery and could not correlate any reduction in strength or functional performance. Similarly Deniel et al also noticed significantly reduced quadriceps strength recovery in tourniquet group at 12 weeks post surgery as compare to non-tourniquet group [17].
Active straight leg raise was not possible in most of the patients who underwent ACL reconstruction with tourniquet inflation. Shelbourne et al. [18] in their accelerated rehabilitation protocol encouraged their patients to walk with full weight bearing and full knee extension on first postoperative day and found their protocol effective than the conventional one in terms of better range of motion (particularly knee extension) and higher strength maintaining stability and preventing an terior knee pain. Theinpont et al. [19] in a study of minimally invasive TKA stated that faster straight leg raising in these patients helps earlier weight bearing short hospital stay and better active full extension. Thus significance of active SLR on day 1 has a better overall functional outcome in patient in terms of rehabilitation.
Pre-operative serum CPK levels were comparable in both groups, while post-operative levels were significantly raised in tourniquet group with p value being less than 0.01 which when compared to the study by Arciero et al. suggested a difference between the groups, but they did not achieve statistical significance (p = 0.12) on post operatively day 1 [12].
The major limitations of our study were first VAS is a subjective score and depends on perception of patient, actual quadriceps strength and cross sectional area were not measured, follow-up was of a shorter period and to study proper rehabilitation of ACL patient a longer follow-up is desirable.
Conclusion
The primary goal of ACL reconstruction is to improve kinematics of knee joint, achieve early full range of motion, progressive weight bearing, earlier strengthening and early return to sports activity. We have done prospective trial involving 45 patients who underwent arthroscopic anterior cruciate ligament reconstruction. In this blinded, parallel-group trial with randomization, we conclude that Tourniquet use is associated with increased pain and analgesic requirement in early postoperative period which affects early rehabilitation of patient and these could be minimized by avoiding tourniquet inflation and using other methods to create bloodless field during ACL reconstruction or using it at lowest possible pressure and for minimum duration.
Compliance with Ethical Standards
Conflict of interest
The authors declare that they have no conflict of interest.
Ethical standard statement
Ethical clearance was approved for our study from the institutional review board (IRB) on 01/08/2018 with certificate number EC/07/18/1383. This study is registered under CTRI with registration number CTRI/2019/02/017542 on 7th February 2019.
Informed consent
For this type of study informed consent is not required.
Footnotes
Publisher's Note
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