Lidocaine and Magnesium and Ketamine in Gynecological Surgery

NCT04622904 | Unknown

• 1 other identifier: 11/2020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pain, Postoperative; Pain, Acute; Pain, Chronic; Pain, Neuropathic; Lidocaine; Ketamine; Magnesium; Central Nervous System Depressants; Analgesics; Neurotransmitter Agents; Analgesics, Non-narcotic

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (19)

• Post Anesthesia Care Unit (PACU) duration of stay

  immediately postoperatively

• sedation on arrival to Post-Anesthesia Care Unit

  immediately postoperatively

• sedation at discharge from Post-Anesthesia Care (PACU) Unit

  at discharge from PACU, approximately 1 hour postoperatively

• sevoflurane consumption during general anesthesia

  change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours

• time to first request for analgesia

  during stay in Post-Anesthesia Care Unit, approximately 1 hour postoperatively

Other Outcomes (2)

• time to emergence

  end of operation, approximately 2 hours after start of surgery

• time to extubation

  end of operation, approximately 2 hours after start of surgery

Study Arms (3)

lidocaine-magnesium group

ACTIVE COMPARATOR

combination of lidocaine and magnesium infusions

Drug: lidocaine-magnesium infusion

lidocaine-ketamine group

ACTIVE COMPARATOR

combination of lidocaine and ketamine infusions

Drug: lidocaine-ketamine infusion

lidocaine group

ACTIVE COMPARATOR

lidocaine infusion alone

Drug: lidocaine infusion

Interventions

lidocaine-magnesium infusion DRUG

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-magnesium group

lidocaine-ketamine infusion DRUG

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-ketamine group

lidocaine infusion DRUG

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

lidocaine group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Gender Eligibility Details: only female patients are subjected to gynecological suregry
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult female patients
• American Society of Anesthesiologists (ASA) classification I-II
• elective open gynecological surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

Aretaieion University Hospital

Athens, 115 28, Greece

RECRUITING

Related Publications (8)

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

  PMID: 29474214 BACKGROUND

• 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.

  PMID: 28742434 BACKGROUND

• Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger 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. doi: 10.1097/SLA.0b013e31805dac11.

  PMID: 17667496 BACKGROUND

• 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.

  PMID: 19843803 BACKGROUND

• 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.

  PMID: 28214095 BACKGROUND

• 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.

  PMID: 28094477 BACKGROUND

• Garcia-Navia JT, Tornero Lopez J, Egea-Guerrero JJ, Vilches Arenas A, Vazquez Gutierrez 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.

  PMID: 26882833 BACKGROUND

• 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.

  PMID: 26840358 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chronic Pain; Neuralgia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Kassiani Theodoraki, PhD, DESA

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassiani Theodoraki, PhD, DESA

CONTACT

+306974634162; ktheodoraki@hotmail.com

Sofia Apostolidou, MD

CONTACT

sofia.apos@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 10, 2020
• Study Start: November 14, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)