Quality of Recovery After General or Spinal Anesthesia for Inguinal Hernia Repair

NCT02696122 | Completed

• 1 other identifier: PUCSP 1.316.318
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quality of Life; Pain, Postoperative; Personal Satisfaction; Postoperative Complication

Keywords

Pain, postoperative; Hernia, abdominal; Anesthesia, spinal; Anesthesia, local; Anesthesia, general; Quality of life; Anesthesia recovery period; Personal satisfaction; Postoperative complications; Quality of recovery

Outcome Measures

Primary Outcomes (1)

• Quality of recovery from anesthesia

  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).

  24 hours

Secondary Outcomes (2)

• Postoperative pain

  24 hours

• Adverse events

  24 hours

Study Arms (2)

Local Group

EXPERIMENTAL

Local infiltration under general anesthesia via laryngeal mask

Procedure: Local Group

Spinal Group

EXPERIMENTAL

Spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine

Procedure: Spinal anesthesia

Interventions

Local Group PROCEDURE

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.

Also known as: Local anesthesia under general anesthesia via laryngeal mask

Local Group

Spinal anesthesia PROCEDURE

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.

Spinal Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I or II , who will be scheduled to undergo unilateral inguinal hernia repair

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidade Catolica de Sao Paulo: lead

Study Sites (1)

Santa Lucinda Hospital

Sorocaba, São Paulo, 18030-230, Brazil

Location

Related Publications (6)

• Kehlet H, White PF. Optimizing anesthesia for inguinal herniorrhaphy: general, regional, or local anesthesia? Anesth Analg. 2001 Dec;93(6):1367-9. doi: 10.1097/00000539-200112000-00001. No abstract available.

  PMID: 11726407 BACKGROUND

• Nordin P, Zetterstrom H, Gunnarsson U, Nilsson E. Local, regional, or general anaesthesia in groin hernia repair: multicentre randomised trial. Lancet. 2003 Sep 13;362(9387):853-8. doi: 10.1016/S0140-6736(03)14339-5.

  PMID: 13678971 BACKGROUND

• O'Dwyer PJ, Serpell MG, Millar K, Paterson C, Young D, Hair A, Courtney CA, Horgan P, Kumar S, Walker A, Ford I. Local or general anesthesia for open hernia repair: a randomized trial. Ann Surg. 2003 Apr;237(4):574-9. doi: 10.1097/01.SLA.0000059992.76731.64.

  PMID: 12677155 BACKGROUND

• Bakota B, Kopljar M, Baranovic S, Miletic M, Marinovic M, Vidovic D. Should we abandon regional anesthesia in open inguinal hernia repair in adults? Eur J Med Res. 2015 Sep 17;20(1):76. doi: 10.1186/s40001-015-0170-0.

  PMID: 26381501 BACKGROUND

• Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration; Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. doi: 10.1002/bjs.7660. Epub 2011 Sep 16.

  PMID: 21928388 BACKGROUND

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Personal Satisfaction; Postoperative Complications; Hernia, Abdominal

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Eduardo T Moro, PhD

  School of Medical and Health Sciences, Pontificial Catholic University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 2, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: January 1, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-10

Locations

BR (1)