Lidocaine infusion for enhanced recovery in hysterectomy: a randomized controlled trial

Jarraya Anouar | Chaabouni Syrine | Majdoub Ali | Kammoun Manel | Trigui Khaled | Moalla Ines | Cheikhrouhou Hichem | Kolsi Kamel |

La tunisie chirurgicale - 2018 ; Vol 2018

Resumé

Continuous infusion of lidocaine has been widely used in colorectal surgery allowing a morphine saving and enhanced recovery program. The aim of this study was to assess the impact intravenous lidocaine on analgesia and enhanced recovery in hysterectomy

Materials and methods: In this study we included 58 ASA I – II class young women (20-60 years) scheduled for   hysterectomy. Our patients were divided into two groups: Group 1: receiving lidocaine at the dose of 1mg / kg before induction and 2mg / kg as maintenance during surgery.Group 2: received placebo.

The anesthesia and analgesia protocol was standardized for both groups. We evaluated the time of the 1st mobilization and the restoration of the transit as well as the postoperative analgesia in the two groups.

Results: Demographic data (age, weight, size) were comparable between the two groups as well as surgical date (the duration of anesthesia and the duration of surgery). The first mobilization time was 13.3 h in group 1 versus 21 h in group 2; p<0.001.The NRS score significantly lower  in group 1 from the first to 24thpost-operative hours. The morphine consumption was 1.38 mg in group 1 versus 6.14 mg in group 2 with p<0.001.

Conclusion: Lidocaine intravenous infusion may be safe and useful for enhanced recovery in hysterectomy as it provides better analgesia and early mobilization comparing with placebo.

Mots Clés

lidocaine , enhanced recovery, hysterectomy , pain relief

Introduction :

The use of lidocaine infusion is now very common in enhanced recovery program in colorectal surgery (1). Studies showed that systemic lidocaine has  anti-inflammatory, analgesic and anti-hyperalgesic effects (2)  and may be useful in opioids saving (3) and enhancing recovery (4) even in other types of surgery (5,6). However, its use in hysterectomy seems to be controversial (7).

The aim of this study was to assess the utility and the impact of systemic lidocaine infusion on analgesia and enhanced recovery after hysterectomy.

 

Article

2. Materials and methods

After obtaining Ethics approval from the Hedi Chaker Hospital committee and informed written consent from patients, we enrolled 58 ASA 1 physical status patients scheduled for hysterectomy via Pfannenstiel incision in a double blind prospective randomized controlled clinical trial. Exclusion criteria included preexisting chronic pain, contraindication to lidocaine or any other products used in the protocol, history of psychiatric, hepatic or renal disease.

The enhanced recovery program and the protocol of the study (Lidocaine per operative infusion) were explained during anesthesia consultation. Starvation time was limited to 6h for solids and 2h for liquids and patients were hospitalized the day of the intervention. The night before intervention we proceed for the same premedication based on 75 mg of oral hydroxyzine in all patients. Anesthesia protocol was standardized. All patients received 8 mg of dexamethasone to prevent post-operative nausea and vomiting and 2 g of Cefazoline as antibioprophylaxis before induction.

Then, patients were randomized into 2 groups using a computer-generated list. Group allocation was concealed in sealed opaque envelopes that were not opened until patient arrival in the operation room.

Group 1 : received 1mg/kg of lidocaine before anesthesia induction and 2mg/kg/h of lidocaine infusion during surgery

Group2 : received placebo.

In this study we used 2 pre-prepared syringes. The first syringe labeled « protocol 1 » and contains 10 ml of lidocaine 1% or normal saline used before anesthesia induction. The second syringe labeled « protocol 2 » and contains 50 ml of lidocaine 1% or normal saline used during anesthesia maintenance. The anesthesia team in charge of the patient was unaware of the content of the syringes.

Induction was done after 3min preoxygenation by 0.2 mg/kg of   ketamine, 0.3 µg/kg of sufentanyl, 3-4 mg/kg of propofoland 0.15 mg/kg of Cisatracrium, the maintainance  was done by propofol (10 mg/kg/h) and 5µg of sufentanil boluses when heart rate or systolic blood pressure increases more than 20 % to the baseline.

Before cutaneous closure, all patients received 1g of paracetamol with 100 mg of ketoprofen intravenously. Then patients were referred to the post anesthesia care unit (PACU) where they stayed for 2 hours. In the PACU, pain was treated by morphine titration (3mg when NRS > 3). Nausea and vomiting were treated by 4mg of ondansetron. The urinary catheter was removed in the PACU.

In the hospitalization Unit, nurses tried the early re-establishment of eating and drinking and the early mobilization (walking) after verifying that the patient have correct hemodynamic parameters, no bleeding, NRS (numeric rating scale) under 3 and no nausea and vomiting.

 All patients (in both groups) received the same intravenous analgesic treatment within the day of the intervention: 1g of paracetamol per 6hours and 80 mg of nefopam per 24 hours. A rescue dose of 100 mg of ketoprofen was used when NRS was up to 3. The target was to maintain NRS (numeric rating scale) under 3.

Nausea and vomiting were treated by the intravenous injection of 4mg of Ondansetran (Zophren®) only when it occurs. All patients received a venous thromboembolism prophylaxis by a subcutaneous injection of 4000 UI of enoxaparin per day from the 6th post-operative hour. Participants, care providers and the research team assessing postoperative outcomes were blinded to our protocol. Serious lidocaine accumulation related side effects were treated by Intralipid® 20% (1.5 ml/kg).

The main outcomes of this study were the time required for the first mobilization and postoperative pain relief. Secondary outcomes were the time required for the gastrointestinal transit re-establishment and side effects that may delay recovery such as nausea and vomiting or urine retention.

The sample size calculation was based on data from a pilot study including 20 patients. The percentage of successful mobilization within the first 12th postoperative hours was 70% in group 1 versus 30 % in group 2. So a sample study of 28 patients in each group was needed for a 95 % confidence level and 5% margin of error

Analysis of the data was performed using a standard statistical program (IBM SPSS Statistics 20.0 Software). We used Chi 2 or fisher tests for qualitative variables and Student test for continuous variables. A p-value ≤ 0.05 was considered significant.

Results

Fifty eight patients were enrolled in this study (29 patients in each group). Demographic and peri-operative parameters were similar in both groups (table 1).

The main result of this study was the time for  walking which was 13.3 h in group 1 versus 21 h in group 2 ; p<0.001. Lidocaine infusion allowed also earlier re-establishment of gastrointestinal transit. The time for the first gas emission was 6.9h in group 1 versus 19.9 h in group 2; p<0.001.

In the peroperative period, Lidocaine infusion reduced the need for opioids and myorelaxants. The table 2 shows the peroperative total dose of sufentanil and cisatracrium consumed. However, hemodynamic parameters (systolic blood pressure and heart rate) were comparable during the intervention.

In the post-operative period, 9 cases needed morphine titration in PACU in group 1 versus 27 cases in group 2 with p<0.001. The average of morphine consumption in group 1 was 1.38 +/- 2.7 mg in group 1 versus 6.14+/-3.09 mg in group 2 (p<0.001). The need for ketoprofen rescue doses was seen in 2 patients in group 1 versus 18 patients in group 2 (p<0.001). Inspite this increasing need of analgesics, the post-operative NRS score was slightly better in group 1 (figure 1).

In this study, we noted no serious lidocaine related side effects like cardiac rhythm changes, heart failure, convulsions or anaphylactic reactions. However, nausea and vomiting were seen in 6 patients in group 1 versus 8 patients in group 2 (p=0.380) and urine retention was seen in 2 patients in each group.

Discussion

In our study, peroperative lidocaine infusion was efficient to enhance recovery after open hysterectomy as it allowed better analgesia, earlier mobilization and earlier re-establishment of bowel transit.  A recent systematic review (6) analyzing 45 trials using perioperative lidocaine infusion showed that doses strongly varied between the studies   (100 mg or 1–3 mg /kg  for induction and 1–5 mg/ kg/h for maintenance)  as well as the duration of the infusion.  In our study we tried to use the same doses as previous studies (6) but we limited the duration of infusion in the peroperative period to avoid any risk of lidocaine overdoses.

The analgesic effect of lidocaine infusion was approved by the majority of studies including patients undergoing laparoscopic abdominal surgery or open abdominal surgery (8), but not for patients undergoing other surgeries like orthopedic, cardiac or neurosurgery (6). This analgesic effects is limited to the 24th first post operative hours (6). Limiting the duration of lidocaine infusion is possible and it was used even in ambulatory anesthesia at the cost of limited duration of analgesic effects (9, 10) which may delay recovery. However, in our study limited lidocaine infusion allowed sufficient analgesia during the day of intervention. 

In open hysterectomy, previous studies are not in favor of the use of lidocaine infusion (7, 11). Grady MV et al (7) showed that neither lidocaine nor ketamine improved the 6-minute walk distance, fatigue, or pain on the second morning after surgery. They explained these result by the efficacy of lidocaine infusion on patients having major open abdominal surgery but not smaller operations which support the proposal of Wu and Liu [9] that the extent of surgery determines the success or failure of lidocaine infusion. However, this study (7) looked for analgesic effect 48 hours after surgery while this effect may be limited to the first 24 post operative hours (6).

Enhanced recovery program is based on early mobilization, early oral intake and correct analgesia (12). The implementation of a fast-track protocol for hysterectomy may be beneficial even without lidocaine infusion (13). 

One of the limits of our study is the limited duration of lidocaine infusion and the short period of date collection (24 hours). The second limit was the duration of stay in hospital which was 3 days for all patients because we respected the protocol of our department.

Conclusion:

Even if previous studies are not in favor of lidocaine infusion for enhanced recovery after hysterectomy (7), this technique seems to be safe and efficient. It allowed per operative opioids saving and myorelaxants consumption decrease. It also improved post-operative analgesia by reducing the need for morphine titration and analgesic rescue doses and improving pain relief. This may help in obtaining early mobilization which is the main goal of enhanced recovery program after hysterectomy.

Table 1: Demographic and peroperative parameters (mean +/- SD)

 

Group 1

Group 2

P value

Age (years)

45.48 +/- 8.81

47.28 +/- 7.66

0.412

Weight (kg)

70.38 +/- 14.39

73.59 +/- 14.68

0.404

Size (cm)

164.59 +/- 5.19

164.72 +/- 5.54

0.922

Duration of the surgery (min)

78.97 +/- 22.49

89.83 +/- 37.90

0.190

Duration of anesthesia (min)

110.86 +/- 26.29

122.24 +/- 38.88

0.197

Preoperative hemoglobin (g/dL)

11.61 +/- 1.09

12.01 +/- 1.25

0.206

 

Table 2: Peroperative sufentanil and cisatracrium consumption (mean +/- SD)

 

Group 1

Group 2

P value

Peroperative Sufentanil total dose (µg)

21.90 +/- 8.80

27.93 +/- 5.59

0.03

Per operative cisatracrium total dose (mg)

14.14 +/- 2.72

16.28 +/- 3.53

0.01

 

Figure 1: Evolution of Numeric rating scale (NRS) postoperatively.

Références

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