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This randomized controlled trial evaluates whether perioperative intravenous lidocaine infusion, combined with port-site ropivacaine infiltration, improves postoperative recovery after laparoscopic abdominal surgery. Participants will be assigned 1:1 to receive either intravenous lidocaine during surgery plus ropivacaine infiltration at surgical closure, or ropivacaine infiltration alone. The primary endpoint is postoperative quality of recovery measured by the QoR-15 questionnaire. Secondary endpoints include postoperative pain and opioid consumption, as well as plasma lidocaine and ropivacaine concentrations to assess systemic exposure and safety.
Participants will be randomly assigned in a 1:1 ratio to one of two perioperative analgesic strategies:
In both groups, trocar/port-site infiltration will be performed by the surgeon at the end of the procedure using ropivacaine 2 mg/mL, with a maximum total volume of 20 mL, injected into the deep musculo-aponeurotic layers of trocar incisions.
All participants will receive standardized general anesthesia and a multimodal postoperative analgesia regimen according to institutional protocols, including scheduled non-opioid analgesics and rescue opioids as needed based on pain intensity.
To assess systemic exposure and safety, plasma concentrations of lidocaine will be measured at predefined time points: 30 minutes after initiation of infusion, at surgical closure, and at 30 minutes, 2 hours, and 6 hours postoperatively. Plasma ropivacaine concentrations will also be measured after infiltration (30 minutes, 2 hours, and 6 hours). These measurements will allow evaluation of peak concentrations, variability, and potential accumulation.
The primary objective of the study is to determine whether the addition of perioperative intravenous lidocaine improves postoperative quality of recovery, assessed using the QoR-15 questionnaire at the predefined postoperative time point(s) specified in the protocol.
Secondary objectives include evaluation of postoperative pain intensity, opioid consumption, and other recovery-related outcomes. In addition, to characterize systemic exposure and support safety assessment of the combined local anesthetic strategy, plasma concentrations of lidocaine will be measured at predefined time points (30 minutes after initiation of infusion, at surgical closure, and at 30 minutes, 2 hours, and 6 hours postoperatively). Plasma ropivacaine concentrations will be measured after infiltration (30 minutes, 2 hours, and 6 hours). These measurements will allow evaluation of peak concentrations, variability, and potential accumulation relative to predefined safety thresholds.
This trial will provide clinically relevant evidence regarding the impact of perioperative intravenous lidocaine on patient-centered recovery after laparoscopic surgery, while also documenting pharmacokinetic exposure and safety when combined with port-site ropivacaine infiltration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Laparoscopic port-site infiltration with Ropivacaine Alone (No IV Lidocaine) |
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| Experimental group | Experimental | IV Lidocaine + laparoscopic port-site infiltration with Ropivacaine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure/Standard care | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Quality of Recovery | Quality of postoperative recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15) QoR-15 score is a validated patient-reported outcome measure evaluating comfort, pain, emotional state, physical independence, and overall well-being. Higher scores indicate better recovery. | Postoperative day 1 (within 24 hours after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma lidocaine concentrations | Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability | day 0 |
| Plasma ropivacaine concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ottilie Trocheris - Fumery, MD | Contact | 33+322089108 | fumery.ottilie@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80480 | France |
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| ropivacaine | Drug | 1 Drug: Ropivacaine (laparoscopic port-site infiltration, surgical closure)
|
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| Lidocaine (intravenous infusion, perioperative) | Drug |
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Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine |
| 30 minutes after port-site infiltration |
| plasmatic accumulation of lidocaine levels | Safety of anesthesia combination in terms of accumulation of lidocaine levels . | at 30 minutes |
| Plasma lidocaine concentrations | Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability | 30 minutes after initiation of infusion |
| Plasma lidocaine concentrations | Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability | 30 minutes after surgery |
| Plasma lidocaine concentrations | Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability | 2 hours after surgery |
| Plasma lidocaine concentrations | Plasma lidocaine concentrations will be measured at predefined perioperative and postoperative time points to characterize systemic exposure, peak concentration, and inter-individual variability | 6 hours after surgery |
| Proportion of patients exceeding predefined safety plasma thresholds | The proportion of participants with plasma lidocaine or ropivacaine concentrations above predefined safety thresholds will be evaluated. | Up to 6 hours postoperatively |
| Postoperative nausea and vomiting (PONV) | Incidence of postoperative nausea and vomiting will be recorded as part of postoperative recovery assessment. | Up to 24 hours postoperatively |
| Plasma ropivacaine concentrations | Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine | 2 hours after port-site infiltration |
| Plasma ropivacaine concentrations | Plasma ropivacaine concentrations will be measured following port-site infiltration to assess systemic absorption and safety when combined with intravenous lidocaine | 6 hours after port-site infiltration |
| Incidence of local anesthetic systemic toxicity (LAST) or adverse events | Occurrence of clinical signs or symptoms suggestive of local anesthetic systemic toxicity (e.g., neurologic or cardiovascular adverse events) and other perioperative adverse events will be monitored. | From induction of anesthesia up to 24 hours postoperatively |
| Length of postoperative hospital stay | Duration of hospitalization following surgery will be recorded as an indicator of recovery and discharge readiness. | From surgery until hospital discharge (up to 30 days) |
| Postoperative pain intensity | Postoperative pain intensity (Numeric Rating Scale, NRS) Postoperative pain will be assessed using an 11-point numeric rating scale (0 = no pain, 10 = worst imaginable pain), measured at rest and/or during movement according to institutional practice | Up to 48 hours postoperatively |
| Postoperative opioid consumption | Occurrence of clinical signs or symptoms suggestive of local anesthetic systemic toxicity (e.g., neurologic or cardiovascular adverse events) and other perioperative adverse events will be monitored | From induction of anesthesia up to 24 hours postoperatively |
| Maximum postoperative pain intensity | Maximum postoperative pain intensity (Numeric Rating Scale, NRS) Description: Maximum postoperative pain intensity assessed using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) during the first 48 hours after surgery. | Up to 48 hours postoperatively |
| Postoperative analgesic consumption | Total consumption of postoperative analgesics, including non-opioid and opioid medications (expressed in morphine equivalents when applicable), during the first 48 hours after surgery | Up to 48 hours postoperatively |
| Incidence of sensory disturbances at the surgical site | Occurrence of peri-incisional dysesthesia, including hyperalgesia, allodynia, or numbness at the operative site, assessed at 48 hours after surgery. | 48 hours postoperatively |
| Incidence of neuropathic pain | Neuropathic pain evaluated using the Douleur Neuropathique en 4 questions (DN4) questionnaire. DN4 is a questionnaire. Neuropathic pain will be defined as a DN4 score >4/10 | 48 hours postoperatively |
| Incidence of neuropathic pain | Neuropathic pain evaluated using the Douleur Neuropathique en 4 questions (DN4) questionnaire. DN4 is a questionanaire with 4 questions; Neuropathic pain will be defined as a DN4 score >4/10 | 3 months postoperatively |
| Time to recovery of bowel function | Time to return of gastrointestinal transit, including first passage of flatus and first bowel movement, as well as tolerance of oral intake, assessed daily by physician interview | up to 30 days |
| Patient satisfaction (EVAN-G score) | Patient satisfaction assessed at discharge using the EVAN-G questionnaire (Evaluation du Vécu de l'ANesthésie Générale), a validated measure of perioperative patient experience. | up to 30 days |
| surgical complications | surgical complications using the Clavien-Dindo score during the postoperative consultation (performed 1 month postoperatively) | at 1 month |
| Number of patients with postoperative chemotherapy | evaluate whether the patient's overall health allows for postoperative chemotherapy if indicated by the oncological multidisciplinary committee (RCP), following the pathological analysis of the surgical specimen | up to 30 days |
| length of hospital stay | length of hospital stay | up to 30 days |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000077212 | Ropivacaine |
| D008012 | Lidocaine |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
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