Quality of Life Clinical Trial
Official title:
Quality of Recovery After Local Infiltration Under General Anesthesia Via Laryngeal Mask or Spinal Anesthesia for Inguinal Hernia Repair.
Verified date | October 2017 |
Source | Pontificia Universidade Catolica de Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | January 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - ASA physical status I or II , who will be scheduled to undergo unilateral inguinal hernia repair Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Santa Lucinda Hospital | Sorocaba | SP |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidade Catolica de Sao Paulo |
Brazil,
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;20:76. doi: 10.1186/s40001-015-0170-0. Review. — View Citation
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. Review. — View Citation
Kehlet H, White PF. Optimizing anesthesia for inguinal herniorrhaphy: general, regional, or local anesthesia? Anesth Analg. 2001 Dec;93(6):1367-9. — View Citation
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. — View Citation
Nordin P, Zetterström 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Postoperative pain | 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. | 24 hours | |
Secondary | Adverse events | Occurrence of nausea, vomiting, shivering, urinary retention | 24 hours |
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