An interventional study of .9 normal saline placebo and Group L (lidocaine) in Surgery, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
The study seeks to investigate a safe and inexpensive strategy to reduce persistent post-surgical pain that can affect up to 60% of patients undergoing surgical procedures.
Hypotheses: Perioperative systemic lidocaine reduces the persistence of chronic pain in patients undergoing surgical procedures.
After approval from Northwestern University's IRB, female subjects undergoing urologic, gynecologic or breast surgery will be included in the study. Informed consent will be obtained from all participants. Subject will be randomized using a computer generated table of random numbers into two groups: Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure. Group P will receive the same amount of saline in the same fashion. This dose regimen of systemic lidocaine chosen in the current study has been consistently associated with a reduction of acute postoperative pain.4 There will be no visual characteristic differences between any of the infusions studied and they will all be labeled as a study drug. Patients will receive a standard anesthetic regimen consisting of propofol, fentanyl, succinylcholine, and sevoflurane. Patients will receive ondansetron 4mg and dexamethasone 4 mg to prevent postoperative nausea and vomiting. They will also receive 10 mcg/kg of hydromorphone at the end of surgery to prevent postoperative pain. In the PACU, patients will receive additional doses of hydromorphone to keep pain \<4/10 (on a scale where 0 means no pain and 10 is the worst pain possible). On PACU discharge, patients will receive a patient-controlled IV hydromorphone analgesia pump set at 0.2mg IV bolus, no basal infusion and a lockout time of 15 minutes. The intraoperative and postoperative data (pain scores, opioid consumption, side effects) will be collected by a research assistant blinded to the group allocation). Other data collection variables include : Preoperative (Age, BMI, ethnicity, comorbidities, preoperative medication(s), psychiatric disease, pain in the operative area, pain at other locations), Intraoperative (description of surgical procedure, surgical duration, surgical procedure on nerve areas, preservation of the nerves in the operative area nerve, indication for the surgical procedure, intraoperative opioids dose, and Postoperative pain instruments (evaluation of early pain, twenty four hour opioid consumption, drugs and other treatments used in the postoperative period.
QOR 40 questionnaire will be completed by the participant at 24 hours after surgery if they have not been discharged from the hospital. If they have been discharged, the research assistant will contact the participant by telephone to complete the questionnaire.
Patients will be evaluated for the presence and severity of chronic pain as well as the quality of life impact of pain at baseline, three and six months after surgery using a validated instrument in accordance with the IMMPACT recommendations to assess chronic pain and its impact on the patient's quality of life (Brief pain Inventory).8 To characterize the chronic pain, both the short form McGill pain questionnaire and the Modified LANNS scale will be also administered at three and six months.9,10 If there is no response to the 3 month questionnaire, the subject will be contacted by telephone to complete the questionnaire.
Subjects who are experiencing suicidal ideation will be referred to Northwestern Memorial Hospital Emergency Department. The primary care surgeon will also be notified by the principal investigator. Mood will be assessed using the Beck Depression Inventory.14
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 148 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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Exclusion Criteria:
Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.
Drug: Group L (lidocaine)
.9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.
Drug: .9 normal saline placebo
Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.
Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.
Number of Participants With Chronic Persistent Pain 3 Months After Surgery as Determined by Character Severity (Yes/no).
The participants development of chronic persistent pain 3 months after surgery as determined by character severity (yes/no).
Time frame: 3 months
Quality of Recovery
Quality of recovery (QoR-40 instrument) is a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Score range: 40 to 200. A score of 40 demonstrates poor recovery and a maximum score of 200 represents good recovery. The higher the score the better recovery after surgery.
Time frame: 24 hours post operative
Post-surgical Persistent Pain Using Validated Questionnaires (S-LANNS Questionnaire, McGill Questionnaire, Brief Pain Inventory) to Assess Pain Qualities in Accordance With IMMPACT Recommendations.
The development of chronic pain 3 months after surgery determined by the Leads Assessment of Neuropathic Symptoms and Signs (LANSS) scale, a valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items), range 0-24 points. A score ≥ 12, neuropathic mechanisms are likely to be contributing to the patient's pain. A score \< 12 is unlikely to be contributing. McGill questionnaire (Sensory domain) - 11 descriptors rated on an intensity scale as 0=none, 1=mild, 2=moderate, 3=severe. The higher the score, greater the pain (range 0-33). McGill questionnaire (Motivational-affective) 4 affect descriptors rated on an intensity scale as 0=none, 1=mild, 2=moderate, 3=severe.The higher the score the greater the pain (range 0-12) Brief pain inventory - pain severity (0, no pain, 10 excruciating pain); Greater the score; greater the pain (range 0-10).
Time frame: 3 months
Opioid Consumption
The amount of opioid analgesics consumed was converted to an equivalent dose of intravenous morphine.
Time frame: 24 hours
Postoperative Pain
Postoperative pain within the first 24 hours. Area under the numeric rating scale for pain versus time curve during the first 24 hours after surgery (score \* hr). Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve during the first 24 hours ( score \* hr). The pain scores were collected upon arrival to recovery area, 30 minutes, 1 hour and every 6 hours up to 24 hours following the procedure. Minimum score is 60, Maximum score is 170. A higher value indicates more pain.
Time frame: 24 hours
| Milestone | Lidocaine (Group L) | .9% Normal Saline Placebo |
|---|---|---|
| Started | 75 | 75 |
| Completed | 74 | 74 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Milestone | Lidocaine (Group L) | .9% Normal Saline Placebo |
|---|---|---|
| Started | 74 | 74 |
| Completed | 43 | 40 |
| Not completed | 31 | 34 |
| Withdrew: Lost to follow-up | 31 | 34 |
The participants development of chronic persistent pain 3 months after surgery as determined by character severity (yes/no).
| participants | Group L | .9% Normal Saline Placebo |
|---|---|---|
| Number of Participants With Chronic Persistent Pain 3 Months After Surgery as Determined by Character Severity (Yes/no). | 2 | 6 |
Quality of recovery (QoR-40 instrument) is a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Score range: 40 to 200. A score of 40 demonstrates poor recovery and a maximum score of 200 represents good recovery. The higher the score the better recovery after surgery.
| units on a scale | Lidocaine (Group L) | .9% Normal Saline Placebo |
|---|---|---|
| Quality of Recovery | 158 (147 to 178) | 169 (151 to 176) |
The development of chronic pain 3 months after surgery determined by the Leads Assessment of Neuropathic Symptoms and Signs (LANSS) scale, a valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items), range 0-24 points. A score ≥ 12, neuropathic mechanisms are likely to be contributing to the patient's pain. A score \< 12 is unlikely to be contributing. McGill questionnaire (Sensory domain) - 11 descriptors rated on an intensity scale as 0=none, 1=mild, 2=moderate, 3=severe. The higher the score, greater the pain (range 0-33). McGill questionnaire (Motivational-affective) 4 affect descriptors rated on an intensity scale as 0=none, 1=mild, 2=moderate, 3=severe.The higher the score the greater the pain (range 0-12) Brief pain inventory - pain severity (0, no pain, 10 excruciating pain); Greater the score; greater the pain (range 0-10).
| units on a scale | Group L | .9% Normal Saline Placebo |
|---|---|---|
| S-LANNS | 3 (0 to 10) | 3 (0 to 8) |
| McGill Questionaire-Sensory Discrimation | 4 (1 to 7) | 3 (1 to 7) |
| McGill Questionaire-Motivational-affective | 0 (0 to 1) | 0 (0 to 2) |
| Brief Pain Inventory | 1 (0 to 3) | 1 (0 to 3) |
The amount of opioid analgesics consumed was converted to an equivalent dose of intravenous morphine.
| equivalent dose of intravenous morphine | Group L | .9% Normal Saline Placebo |
|---|---|---|
| Opioid Consumption | 34 (17 to 46) | 39 (21 to 57) |
Postoperative pain within the first 24 hours. Area under the numeric rating scale for pain versus time curve during the first 24 hours after surgery (score \* hr). Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve during the first 24 hours ( score \* hr). The pain scores were collected upon arrival to recovery area, 30 minutes, 1 hour and every 6 hours up to 24 hours following the procedure. Minimum score is 60, Maximum score is 170. A higher value indicates more pain.
| score on a scale | Group L | .9% Normal Saline Placebo |
|---|---|---|
| Postoperative Pain | 116 (88 to 142) | 119 (91 to 148) |
Collected over 24 hours after surgery completion.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group L | — | 0/74 (0%) | 0/74 (0%) |
| .9% Normal Saline Placebo | — | 0/74 (0%) | 0/74 (0%) |
| Age, Categorical(Participants) | Group L | .9% Normal Saline Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 75 | 75 | 150 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Group L | .9% Normal Saline Placebo | Total |
|---|---|---|---|
| Female | 75 | 75 | 150 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | Group L | .9% Normal Saline Placebo | Total |
|---|---|---|---|
| White | 58 | 60 | 118 |
| African American | 12 | 10 | 22 |
| Asian | 2 | 3 | 5 |
| Hispanic | 2 | 2 | 4 |
| Other | 1 | 0 | 1 |
| Region of Enrollment(participants) | Group L | .9% Normal Saline Placebo | Total |
|---|---|---|---|
| United States | 75 | 75 | 150 |
| Body Mass Index (BMI)(kg/mg^2) | Group L | .9% Normal Saline Placebo | Total |
|---|---|---|---|
| Mean | 24 (21 to 29) | 25 (22 to 30) | 24.5 (21 to 30) |
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