Lidocaine and Outpatient Gynecologic Laparoscopy
Condition: Pain
Study type: Interventional

Summary: 
      Although ambulatory gynecological laparoscopy is considered to be a minimally invasive
      surgical procedure, only 60% of patients undergoing this procedure are satisfied with
      postoperative pain control. Postoperative pain can lead to physiological, immunological and
      psychological derangements in patients.It also has been shown to be the most common cause of
      hospital admission after outpatient surgery.

      Opioids constitute the most commonly used pain management strategy after surgery, however
      they have many undesirable side effects including nausea, vomiting and respiratory
      depression. Different strategies have been developed to decrease the amount of opioid
      required after surgery. Opioid sparing drugs as well as regional anesthesia have been shown
      to be effective. Systemic administration of lidocaine has been shown to decrease opioid
      consumption, improve recovery of bowel function and promote a better recovery after inpatient
      procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and
      anti-inflammatory properties. It also has an excellent safety profile when give by a low-dose
      infusion.

      The improvement of surgical technique and anesthesia care has made major adverse outcomes
      infrequent, especially in the ambulatory setting. Assessing patient's quality of recovery has
      become an important outcome in several studies. The patient's capacity to return to his
      normal activities is one of the most important sign of a successful outpatient procedure and
      it has significant economic implications.

      Quality of recovery -40(QoR-40) is a validated 40 item instrument to assess the quality of
      post-operative recovery. Myels et al. have concluded that the QoR-40 would be a useful
      outcome measure to assess the impact on changes in health care delivery, but anesthesia
      studies underutilize this instrument.

      The research question for the study is; does the use of systemic perioperative lidocaine
      improve quality of recovery after outpatient laparoscopy?
    

Detailed description: 
      70 subjects will be randomly allocated into 2 groups, using a computer generated table of
      random numbers. Group A (study group) will receive lidocaine. Group B (control group) will
      receive the same volume of saline infusion. The study drugs will be prepared by one of the
      investigators in the study. Subjects will be recruited up to 21 days prior to surgery.They
      will be premedicated with intravenous (IV) midazolam 0.04 mg/kg. Routine ASA monitors will be
      applied. Anesthesia will be induced with remifentanil infusion started at 0.1 mcg/kg/minute
      titrated to keep blood pressure within 20% of the baseline and propofol 1.0 -2.0 mg/kg. Group
      A will receive lidocaine 1.5mg/kg bolus and Group B the equivalent volume of saline. Subjects
      will be monitored with a 5 lead EKG throughout the lidocaine administration and if any
      arrhythmia is detected. The study drug will be stopped and investigators unblinded.

      Tracheal intubation will be facilitated with rocuronium (0.6 mg/kg) or succinylcholine (1-2mg
      /kg). Immediately after the induction, group A will receive lidocaine infusion (2 mg/kg/hr
      IV). Group B will receive the equivalent volume of saline; both infusions will be continued
      until 1 hour after arrival in the PACU. Anesthesia will be maintained with desflurane
      titrated to maintain a bispectral index (BIS) between 40-60 , remifentanil infusion started
      at 0.1mcg/kg/min titrated to keep blood pressure within 20 % of baseline values , and
      rocuronium that will be administered at the discretion of the anesthesiologist. Upon
      termination of the surgery, neuromuscular blockade will be antagonized with a combination of
      neostigmine 0.05mg/kg and glycopyrrolate 0.01 mg/kg. Ondansetron 4 mg IV will be administered
      to prevent postoperative nausea and vomiting. Subject will be evaluated for pain in the OR
      after extubation, using a numeric rating scale, if pain greater than 4/10 they will receive
      hydromorphone (10 mcg/kg IV). In PACU, subjects will receive IV hydromorphone in divided
      doses as needed to achieve a verbal rating score for pain <4 out of 10 and they will be
      evaluated every 15 minutes .They will also receive metoclopramide (20 mg IV ) as rescue
      antiemetic in PACU. Discharge readiness will be assessed by a PACU nurse using the modified
      Post Anesthesia Discharge Scoring System (MPADSS) score every 15 minutes for about 3 hours or
      until ready for discharge.The primary and secondary outcomes will be assessed by an
      independent observer who will be blinded to group allocation. Study personnel will contact
      the subject at 24 hours to assess well being, (nausea, vomiting and opioid consumption.
      Subject will be contacted by telephone by the study staff and will complete the Modified
      Quality of Recovery 40 (MQOR40) at 24 hours post surgery.
    

Intervention name(s): Placebo; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): Placebo will receive the same volume of saline infusion.; Lidocaine administration 1.5 mg/kg bolus followed by a 2 mg/kg/hr infusion via intravenous catheter
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; MQOR 40; Lidocaine; Gynecologic; Surgery; Laparoscopic