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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04622904
Other study ID # 11/2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 14, 2020
Est. completion date November 2023

Study information

Verified date October 2022
Source Aretaieion University Hospital
Contact Kassiani Theodoraki, PhD, DESA
Phone +306974634162
Email ktheodoraki@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine and magnesium versus a combination of intravenous infusions of lidocaine and ketamine versus an intravenous infusion of lidocaine alone on recovery profile, quality of recovery and postoperative pain after elective gynecological surgery


Description:

Inadequately treated postoperative pain after gynecological surgery may untowardly affect early recovery and also lead to the development of chronic pain. Opioid-based analgesia is associated with side-effects, such as respiratory depression, postoperative nausea and vomiting and occasional induction of tolerance and hyperalgesia. Therefore, in recent years research has focused on the quest for non-opioid-based regimens for perioperative analgesia in the context of multimodal analgesic techniques. These techniques have been shown to possess significant advantages, such as allowing earlier mobilization after surgery, early resumption of enteral feeding and reduced hospital length of stay. In this context, the intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control, reduce opioid consumption and improve the quality of postoperative functional recovery after general anesthesia. Intraoperative infusions of ketamine (an N-methyl-D-aspartate receptor inhibitor) have also been correlated with reduced pain scores and a decrease in analgesic requirements postoperatively. Lastly, magnesium (acting through modification of the action of N-methyl-D-aspartate receptors) is another agent, which, as an adjuvant to general anesthesia may improve postoperative recovery and pain control through inhibition of cardiovascular response, reduction in general anesthetic needs, enhanced analgesia and anti-inflammatory response. There is insufficient data in literature investigating the effect of combinations of these agents intraoperatively. It would be of interest to demonstrate whether the administration of combinations of infusions can lead to enhanced postoperative recovery, an improved opioid-sparing effect and a decrease in the development of chronic pain as compared to the administration of a sole agent alone. Therefore, the aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine and magnesium versus a combination of intravenous infusions of lidocaine and ketamine versus an intravenous infusion of lidocaine alone on recovery profile, quality of recovery and postoperative pain after elective gynecological surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date November 2023
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria: - adult female patients - American Society of Anesthesiologists (ASA) classification I-II - elective open gynecological surgery Exclusion Criteria: - body mass index (BMI) >35 kg/m2 - contraindications to local anesthetic administration or non-steroidal agents administration - systematic use of analgesic agents preoperatively - chronic pain syndromes preoperatively - neurological or psychiatric disease on treatment - pregnancy - severe hepatic or renal disease - history of cardiovascular diseases/ arrhythmias/ conduction abnormalities - drug or alcohol abuse - language or communication barriers - lack of informed consent

Study Design


Intervention

Drug:
lidocaine-magnesium infusion
A bolus dose of lidocaine of 1.5 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Then, 3 mg/kg/h of lidocaine will be administered intraoperatively. A bolus dose of ketamine of 0.35 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Followingly, 0.2 mg/kg/h of ketamine will be administered intraoperatively diluted in a 60 mL syringe and administered at a rate of 20 mL/h
lidocaine-ketamine infusion
A bolus dose of lidocaine of 1.5 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Then, 3 mg/kg/h of lidocaine will be administered intraoperatively. A bolus dose of magnesium of 50 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Followingly, 10 mg/kg/h of magnesium will be administered intraoperatively diluted in a 60 mL syringe and administered at a rate of 20 mL/h
lidocaine infusion
A bolus dose of lidocaine of 1.5 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Then, 3 mg/kg/h of lidocaine will be administered intraoperatively. A bolus dose of normal saline 100 mL will be administered preoperatively within 10 minutes. Followingly, normal saline will be administered intraoperatively at a rate of 20 mL/h

Locations

Country Name City State
Greece Aretaieion University Hospital Athens

Sponsors (1)

Lead Sponsor Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (8)

Arikan M, Aslan B, Arikan O, Horasanli E, But A. Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study. Acta Cir Bras. 2016 Jan;31(1):67-73. doi: 10.1590/S0102-865020160010000010. — View Citation

Brandsborg B, Nikolajsen L. Chronic pain after hysterectomy. Curr Opin Anaesthesiol. 2018 Jun;31(3):268-273. doi: 10.1097/ACO.0000000000000586. Review. — View Citation

García-Navia JT, Tornero López J, Egea-Guerrero JJ, Vilches Arenas A, Vázquez Gutiérrez T. Effect of a single dose of lidocaine and ketamine on intraoperative opioids requirements in patients undergoing elective gynecological laparotomies under general anesthesia. A randomized, placebo controlled pilot study. Farm Hosp. 2016 Jan 1;40(1):44-51. doi: 10.7399/fh.2016.40.1.9339. — View Citation

Haryalchi K, Abedinzade M, Khanaki K, Mansour Ghanaie M, Mohammad Zadeh F. Whether preventive low dose magnesium sulphate infusion has an influence on postoperative pain perception and the level of serum beta-endorphin throughout the total abdominal hysterectomy. Rev Esp Anestesiol Reanim. 2017 Aug - Sep;64(7):384-390. doi: 10.1016/j.redar.2016.11.009. Epub 2017 Feb 14. English, Spanish. — View Citation

Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. Use of Regional Anesthesia Techniques: Analysis of Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):898-902. doi: 10.1089/lap.2017.0339. Epub 2017 Jul 25. — View Citation

Herroeder S, Pecher S, Schönherr ME, Kaulitz G, Hahnenkamp K, Friess H, Böttiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. Erratum in: Ann Surg. 2009 Apr;249(4):701. Dijkgraaf, Omarcel G W [corrected to Dijkgraaf, Marcel G W]. — View Citation

Sen H, Sizlan A, Yanarates O, Emirkadi H, Ozkan S, Dagli G, Turan A. A comparison of gabapentin and ketamine in acute and chronic pain after hysterectomy. Anesth Analg. 2009 Nov;109(5):1645-50. doi: 10.1213/ANE.0b013e3181b65ea0. — View Citation

Xu SQ, Li YH, Wang SB, Hu SH, Ju X, Xiao JB. Effects of intravenous lidocaine, dexmedetomidine and their combination on postoperative pain and bowel function recovery after abdominal hysterectomy. Minerva Anestesiol. 2017 Jul;83(7):685-694. doi: 10.23736/S0375-9393.16.11472-5. Epub 2017 Jan 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other time to emergence time from sevoflurane discontinuation to first patient response (eye opening) end of operation, approximately 2 hours after start of surgery
Other time to extubation time from sevoflurane discontinuation to tracheal extubation end of operation, approximately 2 hours after start of surgery
Primary change from baseline in Quality of Recovery (QoR)-15 score after surgery The QoR-15 is a quality of recovery scale that consists of 15 questions (items),including questions regarding pain (2 items), physical comfort (5 items), self-care ability (2 items), psychological support (2 items) and emotional state (4 items). Every item is scored on a scale of 10, with the lowest total score of 0 and the highest score of 150. The higher the score, the better the recovery quality of the patient 24 hours postoperatively
Primary pain score on arrival to Post-Anesthesia Care Unit (PACU) pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" immediately postoperatively
Primary pain score at discharge from Post-Anesthesia Care Unit (PACU) pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" at discharge from PACU, approximately 1 h postoperatively
Primary pain score 3 hours postoperatively pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" 3 hours postoperatively
Primary pain score 6 hours postoperatively pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" 6 hours postoperatively
Primary pain score 24 hours postoperatively pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" 24 hours postoperatively
Primary pain score 48 hours postoperatively pain score by the use of Numeric Rating Scale (NRS) 48 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" 48 hours postoperatively
Secondary Post Anesthesia Care Unit (PACU) duration of stay duration of patient stay at PACU immediately postoperatively
Secondary sedation on arrival to Post-Anesthesia Care Unit sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain immediately postoperatively
Secondary sedation at discharge from Post-Anesthesia Care (PACU) Unit sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain at discharge from PACU, approximately 1 hour postoperatively
Secondary sevoflurane consumption during general anesthesia the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours
Secondary time to first request for analgesia the time for the first patient request for analgesia will be noted during stay in Post-Anesthesia Care Unit, approximately 1 hour postoperatively
Secondary morphine consumption in Post-Anesthesia Care Unit (PACU) mg of morphine requested during patient PACU stay immediately postoperatively
Secondary morphine consumption in the first 48 hours patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 48 hours postoperatively 48 hours postoperatively
Secondary sleep quality subjective evaluation of sleep quality by patients, based on a sleep questionnaire (evaluation of sleep duration, number of nocturnal awakenings and marking of sleep quality) 24 hours postoperatively
Secondary first mobilization after surgery patients will be questioned regarding the time at which they mobilized after surgery 24 hours postoperatively
Secondary gastrointestinal recovery after surgery patients will be questioned regarding the time they first felt enteral sounds and the time they had their first flatus after surgery 48 hours postoperatively
Secondary satisfaction from postoperative analgesia satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction 24 hours postoperatively
Secondary first fluid intake patients will be questioned regarding the time they had their first fluid intake 48 hours postoperatively
Secondary first solid intake patients will be questioned regarding the time they had their first solid intake 48 hours postoperatively
Secondary hospitalization time duration of hospital stay after surgery in days 96 hours postoperatively
Secondary fentanyl requirement during surgery dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value intraoperatively
Secondary side effects intraoperatively patients will be monitored for side-effects of the administered agents intraoperatively intraoperatively
Secondary side effects postoperatively patients will be monitored for side-effects of the administered agents postoperatively 72 hours postoperatively
Secondary incidence of chronic pain 1 month after surgery occurrence of chronic pain at the site of the operation 1 month after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement 1 month after surgery
Secondary incidence of chronic pain 3 months after surgery occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement 3 months after surgery
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