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Lidocaine and Outpatient Gynecologic Laparoscopy

The Effect of Perioperative Systemic Lidocaine on Quality of Recovery After Outpatient Gynecologic Laparoscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01250002
Enrollment
70
Registered
2010-11-30
Start date
2010-11-30
Completion date
2011-10-31
Last updated
2014-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain, MQOR 40, Lidocaine, Gynecologic, Surgery, Laparoscopic

Brief 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.

Interventions

DRUGPlacebo

Placebo will receive the same volume of saline infusion.

DRUGLidocaine

Lidocaine administration 1.5 mg/kg bolus followed by a 2 mg/kg/hr infusion via intravenous catheter

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* Female patients undergoing outpatient laparoscopic gynecologic surgery * American society of anesthesiologists class (ASA) Physical status (PS) I and II * Age between 18 and 64 years * Fluent in English * Body mass index (BMI) less than 35

Exclusion criteria

* History of allergy to local anesthetics * History of chronic opioid use * Pregnant patients * Body Mass Index (BMI) greater than 35 * History of electrocardiogram (EKG) abnormalities * Hepatic Impairment * History of congestive heart failure * Electrocardiogram (EKG) abnormalities * History of heart block (subject with history of heart block) * Current use of anti-arrhythmic medications Drop -Outs: * Patient or surgeon request * Conversion of the surgery from laparoscopic to open

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery 40 Score24 hours post surgeryQuality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).

Secondary

MeasureTime frameDescription
Opioid Consumption (Morphine Equivalents)24 hoursopioid consumption (morphine equivalents)post operatively

Countries

United States

Participant flow

Recruitment details

Subjects were recruited in the preoperative area of the hospital between November 2010 and September 2011.

Pre-assignment details

All participants were assigned to groups.

Participants by arm

ArmCount
Group A (Study Group) Lidocaine
Group A (study group) Lidocaine administration
35
Placebo
Group B (control group) will receive the same volume of saline infusion.
35
Total70

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyChange to open surgical procedure43

Baseline characteristics

CharacteristicPlaceboGroup A (Study Group) LidocaineTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
35 Participants35 Participants70 Participants
Age, Continuous39.1 years
STANDARD_DEVIATION 9.3
37.2 years
STANDARD_DEVIATION 8.6
38.2 years
STANDARD_DEVIATION 9
Region of Enrollment
United States
35 participants35 participants70 participants
Sex: Female, Male
Female
35 Participants35 Participants70 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
12 / 3517 / 35
serious
Total, serious adverse events
0 / 350 / 35

Outcome results

Primary

Quality of Recovery 40 Score

Quality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).

Time frame: 24 hours post surgery

Population: Intent to treat.

ArmMeasureValue (MEDIAN)
Group A (Study Group) LidocaineQuality of Recovery 40 Score175 units on a scale
PlaceboQuality of Recovery 40 Score157.5 units on a scale
Secondary

Opioid Consumption (Morphine Equivalents)

opioid consumption (morphine equivalents)post operatively

Time frame: 24 hours

ArmMeasureValue (MEDIAN)
Group A (Study Group) LidocaineOpioid Consumption (Morphine Equivalents)20 mg
PlaceboOpioid Consumption (Morphine Equivalents)30 mg

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026