Quality of Recovery After Local Infiltration Under General Anesthesia Via Laryngeal Mask or Spinal Anesthesia for Inguinal Hernia Repair.
Description:
Inguinal hernia repair is one of the most commonly performed operations worldwide. The
recommended treatment is surgery, which has undergone important advances in the last two
decades. Different anesthetic techniques have been proposed for carrying out such procedures,
including local anesthesia, regional and general. Even though local anesthesia (so called
monitored anesthesia care) is a more cost effective anesthetic technique for inguinal hernia
repair, general and spinal anesthesia remain the most popular anesthetic techniques at
university based teaching programs. It has been suggested that the use of local anesthetic
techniques requires greater surgical skill in the handling of tissues and that, therefore,
less skilled surgeons find it more convenient to operate under general or spinal anesthesia.
The choice of anesthesia is influenced by several factors, including surgeon or
anesthesiologist preferences, patient characteristics, cost or length of hospital stay.
Despite its popularity, spinal anesthesia can lead to side effects as urinary retention,
hypotension, motor block of lower extremities and headache. A recent systematic review
evaluated studies on the influence of anesthetic technique in controlling the occurrence of
postoperative pain in patients undergoing inguinal hernia repair. According to the authors,
local anesthesia, with or without general anesthesia is more effective considering the
avoidance of adverse events compared to spinal anesthesia. Traditionally, anesthesia and
surgery studies have assessed outcomes such as time to wake or hospital stay and the
incidence of nausea, vomiting, pain or other adverse events. Recently, a measurement that
probes quality of life from the perspective of the patient has been considered as a more
important factor in clinical studies that wish to investigate the effect of anesthesia and
surgery on patient recovery and satisfaction. The Quality of Recovery-40 questionnaire
(QoR-40), a validated instrument for this purpose, allows an objective evaluation of the
factors that can influence the perception of the patient, and has been used successfully to
assess the degree of recovery after several different surgical and anesthetic techniques.
There are no recent data on the application of this instrument to assess which anesthetic
technique, local infiltration under general anesthesia via laryngeal mask or spinal
anesthesia, would provide better quality of recovery in the opinion of the patients
undergoing inguinal hernia repair. The aim of the study is to perform a randomized clinical
trial comparing the quality of recovery after local infiltration under general anesthesia via
laryngeal mask or spinal anesthesia for unilateral inguinal hernia repair.
METHODS This randomized trial was approved by the Research Ethics Committee of the School of
Medical and Health Sciences, Pontifical Catholica University of São Paulo, approval number
45087615.0.0000.5373. Written consent form will be obtained from all participants. Seventy
patients aged 18 to 65 years old, with an American Society of Anesthesiologists (ASA)
physical status I or II, who will bee scheduled to undergo local infiltration under general
anesthesia via laryngeal mask or spinal anesthesia for unilateral inguinal hernia repair at
Santa Lucinda Hospital will be enrolled in the study. Patients who (i) refuse to participate
in the study; (ii) are not able to communicate due to alterations in the level of
consciousness, or neurologic, or psychiatric disease; (iii) present with contraindication to
any of the drugs used in the present study; (iv) have history of alcohol or drug dependence;
(v) are super obese as defined by a body mass index (BMI) ≥ 40; and (vi) undergo operation
for recurrent, strangulated, incarcerated or bilateral hernia will excluded from the study.
Study Sequence No premedication will be applied to the patients. Patients´ preoperative data
including age, gender, physical status, BMI and hernia type according to Nyhus classification
will be collected
Randomization The sample size for the following step was calculated considering 90% power to
detect a 10-point difference in QoR-40, which indicated the need to include 31 participants
in each group. Taking possible losses into consideration, the final sample will include 70
participants, which will be allocated to two groups according to a random number sequence
from a web-based random-number generator (available at www.random.com). Because of
significant difference between the anesthetic techniques, the patient and the investigators
will be blinded to group allocation, but not the anesthesia. The anesthetic technique to be
used for each individual participant will be kept in an opaque and sealed envelope, which
will be opened at the time of surgery.
Anesthesia
On arrival at the operating room, standard ASA monitors will be applied. Intravenous
midazolam (0.06 to 0.08 mg.kg-1) and 1% lidocaine (30 mg) will be administered immediately
after venoclysis. The anesthesia will be performed according to the following sequence:
L Group – General anesthesia willl be induced with propofol 2 mg mg. kg-1 and alfentanyl 30
mcg.kg-1. Once an appropriate depth of anesthesia had been obtained, a laryngeal mask airway
(LMA) will be positioned. The anesthesia will be maintained by propofol 4 to 5 mg. kg-1.h-1.
Ventilation will be controlled by adjusting the flow volume and respiratory rate to keep the
end-tidal CO2 level (PETCO2) between 30 and 40 mmHg. For local anesthesia, approximately 50
ml of 0.5% ropivacaine will be infiltrated along the line of incision in the subcutaneous
plane, followed by peripheral nerve block technique (e.g., ilioinguinal-hypogastric nerve
block) and local wound infiltration at the fascial level. Failure of local anesthesia will be
defined as the presence of movements, sweating, tachycardia or blood pressure increase >10%
of the pre-induction value with the beginning of the surgery. In these cases further
infiltration of additional 10 mL of 0.5% ropivacaine will be allowed. At the end of the
surgery, propofol will be discontinued and the LMA removed whenever the patients resume
adequate spontaneous breathing.
S Group – In the S group, spinal puncture will be performed with the patient in the sitting
position, using 27 Gauge (27G) disposable Quincke needles (B. Braun, Meisungen, AG). After
obtaining cerebral spinal fluid (CSF), 15 mg of 0.5% hyperbaric bupivacaine will be injected.
In case of complete failure, a new puncture will be performed and the same dose of anesthetic
drug injected. In cases of partial failure, the anesthesia will be converted to general
anesthesia and the patient excluded from the study. All the patients will be sedated with
propofol by continuous infusion at an initial dose of 0.5 mg.kg-1 followed by 2 to 5 mg.
kg-1.h-1 as necessary to reach level 5 on Ramsay Sedation Scale. The Lichtenstein
tension-free method of inguinal hernia repair will be used in both groups and all procedures
will be performed by the same surgical team. Patients who exhibit reductions in systolic
arterial pressure (SAP) greater than 30% will be given ephedrine (10 mg). Lactated Ringer’s
solution will be used for fluid replacement therapy at a rate of approximately 500 ml
throughout the first 30 minutes, and, then, 2 ml.kg-1.h-1. All of the participants will be
given i.v. ketoprofen (100 mg) before the end of the surgery. The time to operating room
discharge will be registered.
Postoperative When stable vital signs and respiration was confirmed, all patients will be
transferred to the post-anesthesia care unit (PACU). Data related to the occurrence of pain,
nausea, vomiting, shivering, urinary retention and the length of stay at the PACU will be
recorded. Pain will be assessed every 15 minutes using a 0-10 numeric pain rating scale,
where zero meant no pain and 10 the worst imaginable pain. Intravenous morphine (1 to 2 mg)
will be administered every 15 minutes to maintain the pain score below 4 (1 mg when the pain
score was <7 and 2 mg when it was ≥7). Postoperative pain relief in the ward was accomplished
by i.v. ketoprofen (100 mg) every 12 hours, dipyrone (30 mg.kg-1, maximum 1 g) every six
hours and tramadol (100 mg) at eight-hour minimum intervals as needed whenever patients judge
that their analgesia is insufficient. Postoperative nausea and vomiting (PONV) will be
treated with i.v. dimenhydrinate (30 mg). Pain score, use of analgesics, and the occurrence
of nausea, vomiting, and other complications during the hospital ward stay will be recorded.
QoR-40 Questionnaire The quality of postoperative functional recovery will be assessed by the
QoR-40 questionnaire, which assesses five dimensions of recovery (physical comfort - 12
items; emotional state - 7 items; physical independence - 5 items; physiological support - 7
items; and pain - 7 items). Each item was rated on a five-point Likert scale: none of the
time, some of the time, usually, most of the time, and all the time. The total score on the
QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).
Condition:
Quality of Life
Treatment:
Local Group
Start Date:
February 2016
Sponsor:
Pontificia Universidade Catolica de Sao Paulo
For More Information:
https://clinicaltrials.gov/show/NCT02696122