Pain, Postoperative Clinical Trial
Official title:
The Effect of a Mixture of Dexmedetomidine-lidocaine-ketamine in One Syringe Versus Opioids on Recovery Profile and Postoperative Pain After Gynecological Laparoscopic Surgery
The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective laparoscopic gynecological surgery
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 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 laparoscopic 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 - bradycardia(<55 beats/minute) - 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,
De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d. Review. — View Citation
Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25. — View Citation
Lavand'homme P, Estebe JP. Opioid-free anesthesia: a different regard to anesthesia practice. Curr Opin Anaesthesiol. 2018 Oct;31(5):556-561. doi: 10.1097/ACO.0000000000000632. Review. — View Citation
Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17. Review. — View Citation
Mauermann E, Ruppen W, Bandschapp O. Different protocols used today to achieve total opioid-free general anesthesia without locoregional blocks. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):533-545. doi: 10.1016/j.bpa.2017.11.003. Epub 2017 Nov 24. Review. — View Citation
Mulier J. Opioid free general anesthesia: A paradigm shift? Rev Esp Anestesiol Reanim. 2017 Oct;64(8):427-430. doi: 10.1016/j.redar.2017.03.004. Epub 2017 Apr 18. English, Spanish. — View Citation
Mulier JP. Is opioid-free general anesthesia for breast and gynecological surgery a viable option? Curr Opin Anaesthesiol. 2019 Jun;32(3):257-262. doi: 10.1097/ACO.0000000000000716. Review. — View Citation
Panchgar V, Shetti AN, Sunitha HB, Dhulkhed VK, Nadkarni AV. The Effectiveness of Intravenous Dexmedetomidine on Perioperative Hemodynamics, Analgesic Requirement, and Side Effects Profile in Patients Undergoing Laparoscopic Surgery Under General Anesthesia. Anesth Essays Res. 2017 Jan-Mar;11(1):72-77. doi: 10.4103/0259-1162.200232. — View Citation
Vigneault L, Turgeon AF, Côté D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | time to emergence | time from sevoflurane discontinuation to first patient response (eye opening) | up to 2-3 hours after start of surgery | |
Other | time to extubation | time from sevoflurane discontinuation to tracheal extubation | up to 2-3 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 Post Anesthesia Care Unit (PACU), approximately 1 hour 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 | |
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 Post Anesthesia Care Unit (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 2-3 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 (PACU), approximately 1 hour postoperatively | |
Secondary | morphine consumption in Post-Anesthesia Care Unit (PACU) | mg of morphine requested during patient PACU stay | immediately postoperatively | |
Secondary | tramadol consumption in the first 48 hours | patients will be followed for cumulative tramadol consumption 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 | 24 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 | 24 hours postoperatively | |
Secondary | first solid intake | patients will be questioned regarding the time they had their first solid intake | 24 hours postoperatively | |
Secondary | hospitalization time | duration of hospital stay after surgery in hours | 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 | 48 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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