Abstract
Introduction
The use of closed-suction drainage systems after total knee arthroplasty (TKA) is common practice in India, but with no consensus on its use. In this retrospective study, we compared whether clamped or unclamped drainage has any advantages over the other in unilateral TKA.
Methods
Group-A (n = 351) had an unclamped drain removed at 24 h postoperative, with measurement of total drainage at 24 h between January 2011 and February 2013. Group B (n = 349) had drains kept for a total of 8 h-clamped for the first 4 h and unclamped for a further 4, between March 2013 to September 2016. Drainage volume, as well as the hemodynamic markers-hemoglobin (Hb) drop, transfusion rate were evaluated.
Results
Mean drain output in Group- A was significantly higher than Group- B (215.64 ml versus 28.34 ml). The postoperative Hb was significantly higher in Group-B (11.46 g/dl versus 10.57 g/dl). Mean Hb drop was significantly higher in Group A (2.16 g/dl versus 1.18 g/dl). The transfusion rates were lower in Group-B, though not statistically significant.
Conclusions
The 4- hour clamping method effectively reduces drain output and fall in hemoglobin. For those who continue using closed suction drains, clamping could prove to be an effective way of reducing post-operative blood loss and the need for transfusions.
Keywords
1. Introduction
Orthopaedic wounds are particularly vulnerable to the development of hematomas owing to the difficulty in securing absolute hemostasis in surgical procedures such as total knee arthroplasty (TKA).
1
For this reason, closed suction drains (CSD) have been in use since many years now. However, controversies persist concerning the use, duration and clamping of CSD in TKA.2
While many authors have reported significant blood loss with the use of CSD, others have found no difference, either in calculated blood loss or transfusions.- Drinkwater C.J.
- Neil M.J.
Optimal timing of wound drain removal following total joint arthroplasty.
J Arthroplast. 1995 Apr; 10 (PubMed PMID: ... 2010 Feb; 25(2):244-8): 185-189https://doi.org/10.1016/j.arth.2008.08.014
2
, - Drinkwater C.J.
- Neil M.J.
Optimal timing of wound drain removal following total joint arthroplasty.
J Arthroplast. 1995 Apr; 10 (PubMed PMID: ... 2010 Feb; 25(2):244-8): 185-189https://doi.org/10.1016/j.arth.2008.08.014
3
, 4
, 5
,8
,9
Generally, bleeding after TKA is known to be concentrated in the immediate post-operative period (37% in 2 h, 49% in 3 h, and 55% in 4 h).
5
During this period, temporary clamping of the drainage to form a tamponade may reduce blood loss. However, if the drain has been clamped for too long, bleeding that occurs after the formation of a tamponade cannot be removed, resulting in a hematoma.10
,- Charoencholvanich K.
- Siriwattanasakul P.
Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial.
Clin Orthop Relat Res. 2011; 469 (2874–80)https://doi.org/10.1007/s11999-011-1874-2
11
Maximum bleeding occurs in the first 4 h, making this the critical period for creating a tamponade.2
Our study reports on the outcomes of clamped versus unclamped CSD in TKA.- Drinkwater C.J.
- Neil M.J.
Optimal timing of wound drain removal following total joint arthroplasty.
J Arthroplast. 1995 Apr; 10 (PubMed PMID: ... 2010 Feb; 25(2):244-8): 185-189https://doi.org/10.1016/j.arth.2008.08.014
2. Methods
We retrospectively analyzed all the cases of primary unilateral TKA performed by the senior surgeon for osteoarthritis at a tertiary care hospital between January 2011 and September 2016. We excluded revision surgeries, cases with known bleeding diathesis and those who underwent TKA for other indications (rheumatoid arthritis, post traumatic arthritis, dysplasias).
Of the 754 patients who met our inclusion criteria, Group A consisted of 351 patients operated between January 2011 and February 2013 with 24 h unclamped drainage.
In 2013, a meta-analysis performed by Tao Li et al. concluded that in-order to create an effective tamponade, the drain must be clamped for the first 4 h and not more than 6 h, else it would negate the benefits of using the drain altogether.
11
The protocol at our institute was changed following this study, with all CSD's kept for a total of 8 h-clamped for the first 4 and unclamped for the subsequent 4. This comprised of Group B with 349 patients from March 2013 to September 2016.
A Romovac (400 mL, negative pressure- 90 mmHg) drain was used in both group and the anti-reflux valve used for clamping in Group B.
A single surgeon performed all operations with the same surgical technique. Under spinal anesthesia, a pneumatic tourniquet was applied with a pressure of 300 mmHg. Following a medial parapatellar arthrotomy, synovium was reflected from the anterior surface of distal femur. A femoral intramedullary alignment rod was used, and the femoral canal was blocked with a bone plug to seal the perforation before implantation of the femoral prosthesis. Cemented posterior cruciate ligament sacrificing (PS) prosthesis was used.
1 g Tranexamic acid was administered intravenously 30 min before surgery. Periarticular infiltrate was injected prior to final implantation (30 ml- 0.5% levobupivacain, 0.5 ml- 75 mg clonidine, 2 ml-100 mcg fentanyl, 10 ml- 1 g m tranexamic acid and 1 ml- 30 mg ketorolac).
12
A 3.2-mm drainage tube was inserted into the joint and the arthrotomy closed subsequently.
The subcutaneous closure was done with the No. 1–0 polyglactin suture and then interrupted subcuticular sutures are taken with absorbable undyed braided 2–0 polyglactin 910 (Lotus™ Sutures) with a half reverse cutting needle.
13
We used both mechanical and chemical deep vein thrombosis prophylaxis.
Anti-embolic stockings and intermittent pneumatic compression devices (IPC) were applied immediately after surgery.
2500 international units (IU) of Dalteparin sodium was given subcutaneously in the evening of the day of the operation, at least 6 h after the procedure. 5000 international units of were administered daily as a single subcutaneous dose for the next three days postoperative. No further chemoprophylaxis was given after discharge. Patients were advised to continue using the anti-embolic stockings.
14
Patients were encouraged to do active knee range of movement, isometric knee exercises and walk the same day of surgery after the effect of spinal anesthesia wore off.
Preoperative laboratory examinations, such as hemoglobin (Hb) and hematocrit (Hct) measurements were sent the morning after surgery. Blood transfusions were given only if the Hb value was less than 8 g/dL or if there were clinical symptoms such as dizziness, hypotension and tachycardia.
We considered ‘Hb drop’ (difference between pre and post-operative Hb) to be a more significant variable/predictor of blood loss than post-operative Hb alone. We also considered transfusion rates as significant variables in our study.
2.1 Statistical analysis
The primary effect variable, used for power calculation analysis, was the blood loss through drains after the TKA. Quantitative data was summarized in form of mean and standard deviation (SD). Pearson's Chi-Square test was applied to check the association between two categorical data. Independent t-test was used to compare two groups of mean. Paired t-test was used to compare outcome before and after intervention. Significant level was set at 5%.
The t-test was used to calculate the differences, including 95% confidence intervals (CI), between the numerical variables in the groups. Statistical Package for the Social Sciences (SPSS) software was used for calculation and p < 0.05 was considered statistically significant.
3. Results
There were 172 women and 179 men with a mean age of 66 years (SD: 7) in Group-A and 170 women and 179 men with a mean age of 67 years (SD: 8) in Group-B. There were no statistical difference in the age and gender between the two groups (p-value = 0.875).
There was no significant difference in mean pre-operative baseline Hb levels between the two groups (p-value = 0.221). Post-operative Hb value was significantly higher in Group B (11.46 g m/dl versus 10.57 g m/dl) (p-value <0.001) as shown in Table 1. Mean Hb drop was significantly higher in Group-A (2.16 versus 1.18 g m/dl) (p-value <0.001). The mean blood volume in the CSD's was also significantly higher in Group-A drain (p-value <0.001) as shown in Table 2.
Table 1Pre and post-operative Hb levels and Hb drop.
| Group | N | Mean | Std. Deviation | P value | |
|---|---|---|---|---|---|
| Pre-op Hb | A | 351 | 12.74 | 1.04 | |
| B | 349 | 12.64 | 0.99 | 0.221 | |
| Post-op Hb | A | 351 | 10.57 | 1.10 | |
| B | 349 | 11.46 | 1.10 | <0.001 | |
| Hb Difference (Hb Drop) | A | 351 | 2.16 | 0.44 | |
| B | 349 | 1.18 | 0.53 | <0.001 |
Table 2Mean blood volume drained.
| Group | N | Mean Volume Blood Drained | Std. Deviation | |
|---|---|---|---|---|
| A | 351 | 215.64 | 51.96 | |
| B | 349 | 28.34 | 14.43 | |
| Mean Difference | 95% Confidence Interval of the Difference | t-value | p-value | |
| Lower | Upper | |||
| −187.303 | −192.969 | −181.637 | −64.904 | <0.001 |
The transfusion rates were lower in Group-B (1.1% versus 3.1%), though not statistically significant (p = 0.115). Transfusions were performed in 4 patients (4 units of Packed RBC's) in Group B compared to 11 patients in Group A (p = 0.115) as shown in Table 3. Patients in Group A had to be transfused (95% CI: 0.41–1.241) more units of Packed RBC's (16 versus 4), though not statistically significant (p = 0.07).
Table 3Blood transfusion rates.
| Transfusion | Group | Total | |
|---|---|---|---|
| A | B | ||
| Yes | 11 (3.1%) | 4 (1.1%) | 15 (2.1%) |
| No | 340 (96.9%) | 345 (98.9%) | 685 (97.9%) |
| Total | 351 (100.0%) | 349 (100.0%) | 700 (100.0%) |
| Chi- square value = 3.297 | |||
| P value = 0.115 | |||
4. Discussion
The ideal method of wound drainage after TKA remains controversial till date. Literature is divided for and against the use of CSD.
15
The proponents for using a CSD suggest that acute hemorrhagic complications like bleeding after TKA can be diagnosed and addressed immediately.16
This can, however, be diagnosed clinically as well. Those against the use of CSD confirm to literature proving that although drainage is meant to reduce the local hematoma, it has been claimed to increase the total blood loss and need for blood transfusions.2
, - Drinkwater C.J.
- Neil M.J.
Optimal timing of wound drain removal following total joint arthroplasty.
J Arthroplast. 1995 Apr; 10 (PubMed PMID: ... 2010 Feb; 25(2):244-8): 185-189https://doi.org/10.1016/j.arth.2008.08.014
3
, 4
, 5
Many surgeons all over India continue to use a CSD after TKA either with or without achieving hemostasis prior to wound closure. In 2013, a meta-analysis performed by Tao Li et al. concluded that in-order to create an effective tamponade, the drain must be clamped for the first 4 h and not for more than 6 h, else it would negate the benefits of using the drain altogether. They suggested a range of four to 6 h for clamping of drains.
14
One of the first studies analyzing this method was published in 1984 in which it was observed that clamping drainage was associated with less blood loss through the drains as compared to continuous suction drainage.
1
Compared to some other similar studies, we experienced less blood loss in our clamped drain group.3
, 4
, 5
The duration of clamping is still being debated with suggestions ranging from one to 24 h. As was reported, clamping for a period of 4 h postoperatively could be expected to reduce bleeding.
6
A longer clamping period has also been reported to be associated with a number of different problems such as delayed wound healing with skin edge necrosis, hematoma and deep venous thrombosis.7
Our study clearly shows that clamping for 4 h significantly reduced the overall drain output and had significantly less Hb drop. The reduced drain output resulted in fewer transfusions in the clamped group (4 versus 11). This reduction in transfusion rates, however, was not statistically significant reduction. This could be attributed to the fact that we included only unilateral TKA's where the overall blood loss is not so significant. The reduced transfusion rates may possibly be significant in bilateral TKA's where higher outputs in non-clamped drains may result in higher transfusion rates.
Moreover, the transfusion rates should be interpreted with caution from the statistical point of view. T-test was used to compare the numeric means of transfused blood units between the groups. As the majority of patients did not need any transfusion, the large number of 0 values affected the results. Thus, we would need a much larger cohort to prove any significance.
Our study has limitations, as it is retrospective in nature, with no randomization. We excluded other etiologies such as rheumatoid arthritis, which could have possibly skewed the statistics. Further studies including various etiologies and bilateral TKA's in a prospective randomized manner would probably be ideal.
5. Conclusions
The 4- hour clamping method effectively reduces drain output and fall in hemoglobin. For those who continue using closed suction drains, clamping could prove to be an effective way of reducing post-operative blood loss and the need for transfusions.
Conflict of interest
The authors declare that there were no financial and non-financial conflicts of interest.
Appendix A. Supplementary data
The following is the Supplementary data to this article:
- Multimedia component 1
References
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- Does temporary clamping of drains following knee arthroplasty reduce blood loss? A randomised controlled trial.Knee. 2001; 8: 325-327https://doi.org/10.1016/S0968-0160 (01) 00095-3
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- Closed suction drainage for hip and knee arthroplasty. A meta-analysis.J Bone Joint Surg Am. 2004; 86-A: 1146-1152
- Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial.Clin Orthop Relat Res. 2011; 469 (2874–80)https://doi.org/10.1007/s11999-011-1874-2
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Chapter 1: Fast Tracking Pathway for Enhanced Recovery and Patient Satisfaction in Total Knee Arthroplasty: Getting Better Sooner.
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Article info
Publication history
Published online: March 25, 2019
Accepted:
March 18,
2019
Received in revised form:
March 18,
2019
Received:
October 11,
2018
Identification
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