Pain, Postoperativeannie-sophiaNCT04622904
Lidocaine and Magnesium and Ketamine in Gynecological Surgery
A study testing lidocaine-magnesium infusion, lidocaine-ketamine infusion and lidocaine infusion in people with Pain, Postoperative and Pain, Acute, run by Aretaieion University Hospital at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Pain, Postoperative, Pain, Acute, Pain, Chronic
- What is being tested?
- lidocaine-magnesium infusion, lidocaine-ketamine infusion and lidocaine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 14 Nov 2020to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult female patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective open gynecological surgery
Who cannot join
- 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
Show all 11Show fewer
- severe hepatic or renal disease
- history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
- drug or alcohol abuse
- language or communication barriers
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
Sofia Apostolidou, MD contact
Greece1 site, 1 recruiting
- Recruiting
Aretaieion University Hospital
Athens, 115 28
Kassiani Theodoraki, PhD, DESA, #306974634162, ktheodoraki@hotmail.com
About this study
Official title: The Effect of Intravenous Infusions of Lidocaine and Magnesium Versus Lidocaine and Ketamine Versus Lidocaine Alone on Recovery Profile and Postoperative Pain After Elective Gynecological Surgery
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
Read the detailed 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.
- Conditions
- Pain, Postoperative, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Lidocaine, Ketamine
- Being tested
- lidocaine-magnesium infusion, lidocaine-ketamine infusion, lidocaine infusion
- Medical subject headings
- Pain, Postoperative, Acute Pain, Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine-magnesium infusionDrug
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 infusionDrug
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 infusionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| lidocaine-magnesium group | Active comparator | combination of lidocaine and magnesium infusions Receives: Drug: lidocaine-magnesium infusion |
| lidocaine-ketamine group | Active comparator | combination of lidocaine and ketamine infusions Receives: Drug: lidocaine-ketamine infusion |
| lidocaine group | Active comparator | lidocaine infusion alone Receives: Drug: lidocaine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 48 hours postoperatively
Secondary outcomes (19)
Post Anesthesia Care Unit (PACU) duration of stay
duration of patient stay at PACU
Measured: immediately postoperatively
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
Measured: immediately postoperatively
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
Measured: at discharge from PACU, approximately 1 hour postoperatively
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
Measured: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours
time to first request for analgesia
the time for the first patient request for analgesia will be noted
Measured: during stay in Post-Anesthesia Care Unit, approximately 1 hour postoperatively
morphine consumption in Post-Anesthesia Care Unit (PACU)
mg of morphine requested during patient PACU stay
Measured: immediately postoperatively
morphine consumption in the first 48 hours
patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 48 hours postoperatively
Measured: 48 hours postoperatively
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)
Measured: 24 hours postoperatively
first mobilization after surgery
patients will be questioned regarding the time at which they mobilized after surgery
Measured: 24 hours postoperatively
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
Measured: 48 hours postoperatively
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
Measured: 24 hours postoperatively
first fluid intake
patients will be questioned regarding the time they had their first fluid intake
Measured: 48 hours postoperatively
first solid intake
patients will be questioned regarding the time they had their first solid intake
Measured: 48 hours postoperatively
hospitalization time
duration of hospital stay after surgery in days
Measured: 96 hours postoperatively
fentanyl requirement during surgery
dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Measured: intraoperatively
side effects intraoperatively
patients will be monitored for side-effects of the administered agents intraoperatively
Measured: intraoperatively
side effects postoperatively
patients will be monitored for side-effects of the administered agents postoperatively
Measured: 72 hours postoperatively
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
Measured: 1 month after surgery
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
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start14 Nov 2020
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, PhD, DESA, Principal investigator, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622904
- Sponsor's protocol ID
- 11/2020
- Acronym
- annie-sophia
- Status last verified
- Oct 2022
- First submitted
- 31 Oct 2020
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brandsborg B, Nikolajsen L. Chronic pain after hysterectomy. Curr Opin Anaesthesiol. 2018 Jun;31(3):268-273. doi: 10.1097/ACO.0000000000000586.
PubMed 29474214Helander 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.
PubMed 28742434Herroeder 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.
PubMed 17667496Sen 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.
PubMed 19843803Haryalchi 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.
PubMed 28214095Xu 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.
PubMed 28094477Garcia-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.
PubMed 26882833Arikan 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.
PubMed 26840358
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Infusions of Lidocaine and Magnesium Versus Lidocaine and Ketamine Versus Lidocaine Alone on Recovery Profile and Postoperative Pain After Elective Gynecological Surgery
- ClinicalTrials.gov ID
- NCT04622904
- Acronym / sponsor ID
- annie-sophia / 11/2020
- Conditions
- Pain, Postoperative, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Lidocaine, Ketamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- 14 Nov 2020 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lidocaine-magnesium group | Active comparator | Drug: lidocaine-magnesium infusioncombination of lidocaine and magnesium infusions |
| lidocaine-ketamine group | Active comparator | Drug: lidocaine-ketamine infusioncombination of lidocaine and ketamine infusions |
| lidocaine group | Active comparator | Drug: lidocaine infusionlidocaine infusion alone |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult female patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective open gynecological surgery
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine-magnesium infusionA 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 | Drug | lidocaine-magnesium group |
| lidocaine-ketamine infusionA 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 | Drug | lidocaine-ketamine group |
| lidocaine infusionA 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 | Drug | lidocaine group |
Primary outcome
change from baseline in Quality of Recovery (QoR)-15 score after surgery
Time frame: 24 hours postoperatively
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
pain score on arrival to Post-Anesthesia Care Unit (PACU)
Time frame: immediately postoperatively
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"
pain score at discharge from Post-Anesthesia Care Unit (PACU)
Time frame: at discharge from PACU, approximately 1 h postoperatively
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"
pain score 3 hours postoperatively
Time frame: 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"
pain score 6 hours postoperatively
Time frame: 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"
pain score 24 hours postoperatively
Time frame: 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"
pain score 48 hours postoperatively
Time frame: 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"
19 secondary outcomes
Post Anesthesia Care Unit (PACU) duration of stay
Time frame: immediately postoperatively
sedation on arrival to Post-Anesthesia Care Unit
Time frame: immediately postoperatively
sedation at discharge from Post-Anesthesia Care (PACU) Unit
Time frame: at discharge from PACU, approximately 1 hour postoperatively
sevoflurane consumption during general anesthesia
Time frame: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours
time to first request for analgesia
Time frame: during stay in Post-Anesthesia Care Unit, approximately 1 hour postoperatively
morphine consumption in Post-Anesthesia Care Unit (PACU)
Time frame: immediately postoperatively
morphine consumption in the first 48 hours
Time frame: 48 hours postoperatively
sleep quality
Time frame: 24 hours postoperatively
first mobilization after surgery
Time frame: 24 hours postoperatively
gastrointestinal recovery after surgery
Time frame: 48 hours postoperatively
satisfaction from postoperative analgesia
Time frame: 24 hours postoperatively
first fluid intake
Time frame: 48 hours postoperatively
first solid intake
Time frame: 48 hours postoperatively
hospitalization time
Time frame: 96 hours postoperatively
fentanyl requirement during surgery
Time frame: intraoperatively
side effects intraoperatively
Time frame: intraoperatively
side effects postoperatively
Time frame: 72 hours postoperatively
incidence of chronic pain 1 month after surgery
Time frame: 1 month after surgery
incidence of chronic pain 3 months after surgery
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Background: PubMed 29474214Brandsborg B, Nikolajsen L. Chronic pain after hysterectomy. Curr Opin Anaesthesiol. 2018 Jun;31(3):268-273. doi: 10.1097/ACO.0000000000000586.
- Background: PubMed 28742434Helander 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.
- Background: PubMed 17667496Herroeder 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.
- Background: PubMed 19843803Sen 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.
- Background: PubMed 28214095Haryalchi 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.
- Background: PubMed 28094477Xu 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.
- Background: PubMed 26882833Garcia-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.
- Background: PubMed 26840358Arikan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia Apostolidou, MD contact
Kassiani Theodoraki, PhD, DESA principal investigator
Aretaieion University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine-magnesium infusion, lidocaine-ketamine infusion and lidocaine infusion in people with Pain, Postoperative and Pain, Acute, run by Aretaieion University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kassiani Theodoraki, PhD, DESA (+306974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in Quality of Recovery (QoR)-15 score after surgery (time frame: 24 hours postoperatively). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04622904, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.