Pain, Postoperative Clinical Trial
— annie-sophiaOfficial 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
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 |
Country | Name | City | State |
---|---|---|---|
Greece | Aretaieion University Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Aretaieion University Hospital |
Greece,
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
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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