Quality of Recovery After General or Spinal Anesthesia for Inguinal Hernia Repair
Condition: Quality of Life; Pain, Postoperative; Personal Satisfaction; Postoperative Complication
MeSH terms: Hernia; Pain, Postoperative; Postoperative Complications; Hernia, Inguinal
Study type: Interventional

Summary: 
      Different anesthetic techniques have been proposed for carrying out Inguinal hernia repair,
      including local anesthesia, regional and general. There are no recent data on the application
      of a validated questionnaire to assess which anesthetic technique, local infiltration under
      general anesthesia 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 (QoR-40) after local
      infiltration under general anesthesia via laryngeal mask (LMA) or spinal anesthesia for
      unilateral inguinal hernia repair. METHODS - Seventy patients aged 18 to 65 years old, who
      were scheduled to undergo unilateral inguinal hernia repair at Santa Lucinda Hospital will be
      enrolled in the study. The anesthesia will be performed according to the following sequence:
      L Group - intravenous (I.V.) propofol and alfentanyl, followed by LMA positioning. The
      anesthesia will be maintained by propofol. 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. S Group - spinal puncture followed by
      intrathecal 15 mg of 0.5% hyperbaric bupivacaine injection and sedation with propofol by
      continuous infusion. Pain will be assessed every 15 minutes at Post-anesthesia Care Unit
      (PACU) using a 0-10 numeric pain rating scale and I.V. morphine will be administered to
      maintain the pain score below 4. The QoR-40 will be administered by a blind investigator 24
      hours after surgery.
    

Detailed 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).
    

Intervention name(s): Local Group; Spinal anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): 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 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% ropivacaive will 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.; Spinal puncture will be performed with the patient in the sitting position, using 27G disposable Quincke needles (B. Braun, Meisungen, AG). After obtaining CSF, 15 mg of 0.5% hyperbaric bupivacaine will be injected.
Other intervention name(s): Local anesthesia under general anesthesia via laryngeal mask
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain, postoperative; Hernia, abdominal; Anesthesia, spinal; Anesthesia, local; Anesthesia, general; Quality of life; Anesthesia recovery period; Personal satisfaction; Postoperative complications; Quality of recovery