normal saline
DrugPatients will receive the irrigation at the end of surgery after dissection; irrigation analgesia by 5 ml bupivacaine 0.50% plus 20 ml normal saline (Group N)
NCT Number: NCT07370181
Patients will be assigned randomly to two groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 60 patients will be allocated in two groups (of 30 patients each) to receive the irrigation at the end of surgery after dissection; irrigation analgesia by 5 ml bupivacaine 0.50% plus 20 ml normal saline (Group N) or 5 ml bupivacaine 0.50% plus 1 mg/kg ketamine (Group K). The volume of irrigation in group K is completed by normal saline to reach a total of 25 ml.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
The anesthetic technique will be standardized for all groups. Anesthesia will be induced with propofol 2 mg.kg-1, fentanyl 1 µg.kg-1 and rocuronium 0.6 mg/kg1for muscle relaxation. The size of the cuffed endotracheal tube will be selected according to the patient's age. Anesthesia and muscle relaxation will be maintained with 2% sevoflurane in a 50% oxygen/air mixture and 0.1 mg/kg rocuronium at fixed intervals. All patients will receive volume-cycled mechanical ventilation in ventilator settings that maintained normocarbia. Intra-operatively, patients will receive IV paracetamol 15 mg/kg and 10 mL/kg infusions of normal saline. Hemodynamic data (HR and MBP) will be monitored during the intraoperative period but recorded at the end of surgery before drug irrigation (T0), after extubation (T1), at postoperative care unit PACU admission (T2), then 30 min (T3), 1 hour (T4) and 2 hours (T5). Blood glucose will be measured using a point-of-care device (ACCU-CHEK©, Roche Pharmaceuticals, Basel, Switzerland) before the start of irrigation (T0), at PACU admission (T1), then after 12 hours (T2) and 24 hours (T3) to assess the effect of study drugs on the stress response.
At the end of the procedure, the residual neuromuscular blockade will be reversed with standard doses of neostigmine and atropine. Patients will be extubated awake in the recovery position and transported to the Post Anesthesia Care Unit (PACU). The anesthesia time (time in minutes from induction of anesthesia till its discontinuation) and time to extubation (time in minutes from the discontinuation of anesthesia till extubation) will be recorded. After fulfilling the criteria for full recovery, patients will be transferred to the ward.
Postoperative pain was assessed at rest and at movement, using a 0-10 cm VAS pain scale, where 0=no pain and 10=the worst pain imaginable. According to the degree of pain given by the patient, the classification of severity was done as follows: No pain = 0, mild pain=1-3, moderate pain= 4-6, and severe pain ≥7. The pain was treated with a bolus of pethidine 1 mg/kg when the reported VAS pain scale is ≥ 4. The score was assessed at 0 (PACU admission), 1, 2, 4, 12, and 24 hours after surgery.
The time to first request rescue analgesia and the total consumption of postoperative rescue analgesics will be recorded. Any perioperative adverse events will be treated and recorded such as hypotension, bradycardia, desaturation (SpO2% < 92%), and postoperative vomiting.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive the irrigation at the end of surgery after dissection; irrigation analgesia by 5 ml bupivacaine 0.50% plus 20 ml normal saline (Group N)
Patients will receive 5 ml bupivacaine 0.50% plus 1 mg/kg ketamine (Group K). The volume of irrigation in group K is completed by normal saline to reach a total of 25 ml.
Other names: Katlar
Time frame: 24 hours
The total consumption of postoperative rescue analgesics was recorded from the time to first request rescue analgesia to patient discharge after 24 h.
Time frame: 24 hours
Postoperative pain was assessed, using a 0-10 cm VAS pain scale, where 0=no pain and 10=the worst pain imaginable. According to the degree of pain given by the patient, the classification of severity was done as follows: No pain = 0, mild pain=1-3, moderate pain= 4-6, and severe pain ≥7.The pain was treated with a bolus of pethidine 1 mg/kg when the reported VAS pain scale is ≥ 4. The score was assessed at 0 (PACU admission), 1, 2, 4, 12, and 24 hours after surgery.
Time frame: 24 hours
The time to first request rescue analgesia will be recorded and treated with a bolus of pethidine 1 mg/kg when the reported VAS pain scale is ≥ 4 .
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Ketamine Irrigation Analgesia: For Controlling Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy
Acronym: Ketamine
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07490457
Cardiac Anaesthesia, Chronic Pain
Bursa, nilüfer, Turkey (Türkiye)
View Trial DetailsNCT07187037
Delayed Emergence from Anesthesia, Nausea
Karatay, Konya, Turkey (Türkiye)
View Trial DetailsNCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT02417337
Irreversible Pulpitis, Neurologic Manifestations
Khartoum, Sudan
View Trial Details