Specialty anesthesia and critical care: res earch on efficiency of pain relief of patient controlled epidural analges IA with ropivacain or bupivacain combined fentanyl after hip replacement surgery in the elderly

MINISTRY OF EDUCATION AND TRAINING MINISTRY OF DEFENSE 108 INSTITUTE OF CLINICAL MEDICAL AND PHARMACEUTICAL SCIENCES NGUYEN THI LE MY RES EARCH ON EFFICIENCY OF PAIN RELIEF OF PATIENT

MINISTRY OF EDUCATION AND TRAINING MINISTRY OF DEFENSE

108 INSTITUTE OF CLINICAL MEDICAL AND

PHARMACEUTICAL SCIENCES

NGUYEN THI LE MY

RES EARCH ON EFFICIENCY OF PAIN RELIEF

OF PATIENT CONTROLLED EPIDURAL ANALGES IA WITH ROPIVACAIN OR BUPIVACAIN COMB INED FENTANYL AFTER HIP REPLACEMENT SURGERY IN THE

TH E TH ESIS W AS DO NE IN: 108 INSTITU TE O F C LINICAL MEDICAL AND PHARMAC EU TICAL SCIENC ES

The thesis can be founde d at:

1 Vietnam Nat ional Library

2 Library of 108 Institute of Clinical Medical and

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INTRODUCTION

Hip replacement is a common surgery for the elderly to treat conditions such as degenerative hip joints, hip fracture, and intermittent fracture… T his is a major surgery t hat invades both the bone and the t issue Therefore, after hip surgery, patients often suffer from severe and prolonged pain, while patients need to exercise early

to enhance recovery and prevent high-risk complications such as embolism due to venous t hrombosis in deep circuit

There are many methods of pain relief after hip surgery that have been studied and applied clinically such as epidural anesthesia, neural body anesthesia, surgical site anesthesia, pain relief due to patient self-controlled intravenous route

Epidural anesthesia is an effective method of pain relief especially in major surgeries with severe and prolonged pain such as thoracotomy, abdominal surgery, spinal surgery, and surgery big joints such as hip joints, knee joints Easy method of prolonging pain relief time by placing catheter in the epidural space for continuous anesthetic infusion or intermitt ent injection However, epidural anesthesia also causes undesirable effect s such as hypotension, motor inhibition T he cause of the above problems is due t o excess anesthetic used t o relieve pain This leads to a blockage

on motor and sympathetic nerves, thereby causing undesirable effects

PCEA: patient contronlled epidural analgesia (P CEA: patient contronlled epidural analgesia) is an epidural analgesia in which the

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patient self-controls the amount of anesthetic introduced into the epidural space This method helps to reduce the dose of drugs used, thereby reducing the blocking area of the anesthetic, reducing undesirable effects

Ropivapcaine is an anesthetic that belongs to the amino amid group It has a good effect with less cardiotoxicity than bupivacaine In addition, the drug has a more inhibitory effect on sensation than a motor inhibitory effect The drug is widely use d in clinical practice in many different anesthetic methods such as spinal anesthesia, epidural anesthesia, plexus anesthesia and continuous infusion of anesthetic at the incision

Worldwide, there have been studies using ropivacaine in pain relief by patients self-control epidural However, in Vietnam, research on patient controlled epidural analgesia using ropivacaine after hip replacement surgery in the elderly is few T herefore, we conduct ed the above study with the following goals:

1 Compare the analgesic and motor block effects of ropivacaine 0.1% - fentanyl 1 mcg/ml with bupivacaine 0.1% - fentanyl 1 mcg/ml in the patient controlled epidural analgesia after hip replacement surgery in the elderly

2 Evaluate the effects on circulation, respiration and the undesirable effects of the two above pain relief methods

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Chapte r 1

O VERVIEW 1.1 The el derly and problems relate d to anesthesia - surgery 1.2 Hip re placement surgery

1 3 PC EA pain relief method

1.3.1 Epidural anesthesia

1.3.1.1 Anatomy of the epidural space

1.3.1.2 The effect of age on the distribution in the epidural space 1.3.1.3 The effect of epidural anesthesia

1.3.2 Self-controlled epidural pain relief

1.3.3 Principle of operation

Figure 1.1: Changes in drug concen tration in blood

Jeffrey A Grass, Anesth Analg Vol 101, pg S44 – S61 1.3.4 PCEA specifications

in the levobupivacaine group of 0.0625%

In 2016, the author Tran Dac T iep studied the analgesic effect of the epidural analgesic method of self-controlled patient using ropivacaine for patients after hip replacement surgery In t he study, the author compared t he effects of patient self-administered epidural anesthesia bet ween the ropivacaine group and the ropivacaine group combined with fentanyl The parameters set on the PCEA are: Required dose: 3 ml

T ime Locked: 10 minutes

Maintenance dose: 3 ml/hour

Maximum total dose in 4 hours: 40 ml

The results of t he method have good analgesic effect with lower

VA S score in the study 4

1.5.2 In the world

The authors Francois J Singelyn and Jean-Marie A Gouverneur conducted a study on the comparison of pain relief effects after total hip replacement surgery between three methods of pain relief Pain

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relief by intravenous morphine P CA, P CEA and 3-in-1 anesthesia In the study, the authors used 0.125% bupivacaine in combination with sulfet anin 1mcg/ml Maintenance dose is used 5-7 ml/h and automatic bolus dose of 2.5 ml every 30 minutes Efficacy was assessed for 48 hours after surgery All three methods of pain relief are equally effective

Author Jan Maca (2020) and colleagues conduct ed a study with the goal of comparing the pain relief effects of PCEA with the relief

of common CEA pain after full hip replacement surgery A total of

119 patients were enrolled in the study After hip replacement surgery the patient was admitted to the intensive care unit and randomized t o one of t wo groups (P CEA 61 patients and non-PCEA

58 patients)

The P CEA group was treated using a setting program with bolus dose of 4 ml/time, lock-in time of 20 minutes, continuous background dose of 3 ml/h, total dose limit of 40 ml/4 hours The non-PCEA group received a continuous infusion of 5 ml/h and 8 ml bolus if the pain score was elevated Total analgesic consumption, patient satisfaction, intensity of pain, and pain relief-related complications were recorded within 24 hours of surgery

The results of the PCEA group with significantly lower total consumption of the pain relief mixture was 0.9 ± 0.3ml/kg/24h compared with 1.3 ± 0.4 ml/kg/24h in the non-PCEA group with p < 0.001 There was higher patient satisfaction (p <0.001) in the P CEA group Average pain intensity over 24 hours post-surgery was similar for both groups (P = 0.14) There was no significant difference in the rates of pain relief-related complications bet ween groups

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Chapte r 2 SUBJEC TS AND METHO DS O F RESEARC H

2.1 Re search obje ct

The patients were assigned to surgery for hip joint surgery at Department B1C and Department of Resuscitat ion Anesthesia, 108 Milit ary Central Hospital

2.1.1 Criteria for selecting patients to study

Age ≥ 60

ASA I-III

Patients can work together for PCEA pain relief

There is no contraindicat ion to epidural anesthesia

Volunteer to participate in research

2.1.2 Exclusion standards

Patients with anesthesia and surgical complicat ions during the study period

2.1.3 Criteria taken out of the study

The patient must have surgery again during the pain relief period The patient must have prolonged mechanical ventilation after surgery

The patient was unable to insert the epidural catheter

2.2 Re search Me thodology

2.2.1 Research design

Clinical, randomized, comparative clinical intervention study

2.2.2 Research time and place

How t o group randomly

Creat e 104 lottery tickets that are put into sealed envelope Of which, 52 cards were writ ten "B", respectively, were the group using 0.01% bupivacaine in combination with fentanyl 1mcg/ml for pain relief and 52 cards with the letter "R" respectively were the group using ropivacaine 0.01% with fentanyl 1 mcg/ml for pain relief When the patient is selected for the study, the ballot will be drawn by himself, depending on t he lottery, the patient will receive the corresponding pain relief

2.2.4 Conduct research

2.2.4.1 Research facilities

2.2.4.2 Drugs used in research

2.2.4.3 Patient examination before surgery

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Physicians wash sterile hands, wear sterile gloves, surgical gown, and a sterile mask Disinfect t he back area to anesthetize with two times of iodine alcohol and one time of 70o white alcohol

Spread surgical chrysotile with sterile holes

- Poking position: can poke inter-joint slots L 1-2 to L 4-5.

- T he landmark for determining the needle puncture position: The straight line connecting the lateral crest goes right above the L4-

5 vertebra

- Anesthetize in place with lidocaine 1% solution

- Use NMC T uohy needle to poke in the direction of the needle

up t o the head, bring the needle about 2-2.5 cm deep, stop to pull out the barrel Use the resistance test to determine the position of the needle inlet to the NMC cavity Using the pressure test pump, both insert the T uohy needle deep into the organization while keeping the pressure in the pump when the T uohy needle enters the epidural cavity will lose the pressure pump resistance

- Insert t he catheter into t he epidural space on t he tip and let the length of the catheter in the epidural space correspond to the catheter tip level at position L1 or D12

- Fix the catheter with tape or opsite

- T est lidocaine 2% 2 ml (with adrenalin 1/200,000 via catheter to distinguish the catheter into t he epidural or subarachnoid cavity or blood vessel) Follow up the patient within 5 minutes if the heart rate> 20% can be catheter into the blood vessel, if the lower extremities can be injected into the subarachnoid space Suspect ed patients were excluded from the study

- The retention time of catheter is 72 hours from the time of epidural pain relief

* C onducting spinal anesthe sia for surgery

2.2.4.5 Conduct postoperative pain relief and postoperative

follow-up

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Pain-relieving conditions: After the patient finishes the surgery

and is t ransferred t o the recovery room, the patient is monitored and evaluated according to the criteria When meeting the standards, it will reduce pain after surgery

- Patient awake

- Pulse, blood pressure, SpO2 is stable

- Patient self-assesses pain level by pulling a corresponding pain gauge

+ If VAS <4, then follow up and reassess every 15 minutes + If VA S> 4, the initial dose should be inject ed to relieve pain after surgery, this is the time of H0 in the study

of medulla of the anesthetic drug after injection into the epidural space has been determined

* How to prepare the drug solution infused into the epidural space:

Bupivacaine group: Take 03 vials of 0.5% 20ml bupivacaine with

03 ampoules of 0.1mg/2ml fentanyl mixed with 0.9% sodium chloride with volume 234ml The mixture received consisted of 300

ml of which bupivacaine concentration 0.1% and fentanyl 1 mcg/ml Ropivacaine group: T ake 7.5 vials of ropivacaine 0.2% 20ml together with 03 ampoules of 0.1mg/2ml fentanyl mixed with 0.9% sodium chloride with a volume of 144ml The resulting mixture has a

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volume of 300ml in which the concentration of ropivacaine 0.1% and fentanyl 1mcg/ml

PCEA Pain Relief Sett ings:

Patients who started on self-administered pain relief after initial dose administration had a VAS score of <4

- Use of drug mixtures for each study group as follows:

+ Group B: use a mixture of Bupivacaine 0.1% + fentanyl 1 mcg/ml

+ Group R: use a mixture of Ropivacaine 0.1% + fentanyl 1 mcg/ml

- Set machine parameters:

Required dose: 3 ml

+ Lock time: 15 minutes to suck

Maintenance dose: 3 ml/hour

+ Total dose limited to 4 hours: 40 ml

During t he study, if, after two consecutive presses of the required dose, the response has a VAS score> 4, the doctor injects an additional "pain relief" dose of 5 ml of pain reliever mixture corresponding to each study group The machine parameters are kept the same Patients were followed for evaluation every 15 minutes for the first 1 hour If VAS score <4, cont inue with the study If 15 minutes after the “rescue” dose, the patient still has pain, it is considered a failure of epidural pain relief and switch t o intravenous morphine PCA

- Withdrawing cat heter after 72 hours from epidural pain relief

2.2.4 Monitoring times

2.2.5 Main evaluation criteria

* Goal 1

- Comparison of resting VA S pain scores at study t imes

- VAS pain points when in motion at the time of the study

- Poke position, block level of pain sensation

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- T ime of onset of analgesic effect

- Blocking level after bolus dose, after 24 hours, after 48 hours, after 72 hours

- The need for PCEA pain relief and the need to take t he "pain relief" dose:

+ Number of requests (D = Demand and request success (A = Act ual, request success rate A/D (%))

+ Number of injections of "rescue pain" doses

+ The volume of the initial dose anesthetic mixture

+ Comparing the amount of bupivacaine and ropivacaine for pain relief in day 1, day 2, day 3 and total dose in three days of pain relief

- The time from t he onset of pain relief t o t he t ime t he patient presses the first required dose

- Patient satisfaction when performing pain relief

nausea Urinary retention Itching Complications related to epidural anesthesia techniques

* Other eva luation criteria

- Anthropometric characteristics of the patient: height (cm), weight (kg), age (years), sex

Preoperative status: ASA, associated chronic pathology

Feat ures anesthesia and surgery:

+ T ime of surgery: From t he start of skin incision t o the end of skin closure

2.2.6 Some standards and definitions used in the study

2.2.7 Handling some unwanted effects

2.2.8 Data processing

2.2.9 Ethical issues in research

1 µg/ml

PC EA installation

Bolus 3 ml/time Lock 15 minutes Limit: 40 ml/4h Base dose: 3 ml/h

Pain assessment based

on VAS scale Record research indicators in data collection form

Stop pain reduct ion Withdrawal of the epidural catheter

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Chapte r 3

RES EARC H RESULTS

3.1 Characteristics of research patients

The mean age in our study was 71.6 ± 8.9, with the lowest age in the study being 60 and the highest at 98 The mean age difference between the two groups, but no difference statistical significance with p > 0.05

The average height of the t wo groups in the study was different but the difference was not statistically significant with p> 0.05 In which the lowest height is 140 cm and the highest is 180 cm

The average weight in the study was 54.4 ± 8.8kg, with the lowest being 36kg and the highest being 81kg The difference in weight of the two groups in the study was not statistically significant with p > 0.05

3.1.8 Surgical proce dures

Figure 3.2: Distribution of surgery type of two groups