Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty
- Conditions
- Postoperative Pain Relief
- Interventions
- Registration Number
- NCT07194694
- Lead Sponsor
- Ain Shams University
- Brief Summary
This clinical trial aims to compare the efficacy of two types of analgesic adjuvants in two groups of adult patients undergoing surgeries on unilateral inguinal hernia repair. The key questions it is expected to answer are:
To what extent do dexmedetomidine and ketamine adjuvants, when combined with bupivacaine, offer a longer analgesic period in a Transversus Abdominis Plane (TAP) block?
To investigate the time to first request pain medications and pain scores, researchers will rely on three groups:
Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1 mcg/kg dexmedetomidine + normal saline.
Group B (ketamine group): patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + 0.5 mg/kg ketamine + normal saline.
Group C (Control Group): Patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + normal saline.
Participants will:
Undergo general anesthesia in their planned hernia repair. Get injected with a TAP block dose of single ultrasound using one of the three study solutions at the completion of the surgery prior to waking.
Measure their pain at rest and coughing with particular time intervals (0, 2, 4, 6, and 12 hours) after the operation.
Take common rescue analgesic (nalbuphine) on request depending on the degree of pain.
- Detailed Description
Preoperative Assessment:
Patients scheduled for inguinal hernioplasty will be assessed preoperatively by evaluation of their medical history, laboratory investigations, and fulfillmentthe above inclusion criteria. The patient's preparation will be done by IV cannulation with an 18G cannula, and infusion of 500 ml of Ringer's solution will be started, and about 20 minutes before anesthesia induction, midazolam (0.05 mg/kg) will be received as a sedative premedication.
Intraoperative Procedures and Assessments:
After reaching the operating room, standard monitoring will be applied, which includes electrocardiography (ECG), non-invasive blood pressure, and pulse oximetry for peripheral oxygen saturation (SPO2). After preoxygenation, induction of general anesthesia will be done by IV injection of propofol (2 mg/kg), fentanyl (2 mcg/kg), atracurium (0.5 mg/kg), and inhalational isoflurane 1.2%, followed by endotracheal intubation and controlled mechanical ventilation with tidal volume 7-8 ml/kg, respiratory rate 12/min, and FIO₂ 100%. Then anesthesia will be maintained by inhalational isoflurane, atracurium 0.1 mg/kg every 20 minutes, and intraoperative fluid (Ringer's solution), which was calculated to cover the maintenance, deficit, and 3rd space requirement.
At the end of surgery an ipsilateral US-guided TAP block will be given to all the patients by placing a linear US probe (high-frequency probe 10-12 MHz) connected to a portable US unit (SonoSite, USA) in the mid-axillary plane midway between the lower costal margin and the highest point of the iliac crest with the patient in a supine position. After skin disinfection, a 22-G needle with an injection line will be inserted in plane with the probe. Once the tip of the needle is placed in the space between the internal oblique abdominal muscle and transversus abdominis muscle, and after negative suction, 5 ml of 0.9% saline will be injected to distend the transversus abdominis plane, then 20 ml of solution will be made.
Group A (Dexmedetomidine Group): patients received 20 ml solution containing 1 mg/kg bupivacaine + 1 mcg/kg dexmedetomidine + normal saline.
Group B (Ketamine Group): patients received 20 ml solution containing 1 mg/kg bupivacaine + 0.5 mg/kg ketamine + normal saline.
Group C (Control Group): Patients received 20 ml of solution containing 1 mg/kg bupivacaine + normal saline. Then discontinuation of inhalational isoflurane and reversal of muscle blockade by a neostigmine 0.05 mg/kg and atropine (0.01-0.02 mg/kg) mixture, and after fulfillment of extubation criteria, extubation was done.
Postoperative analgesic regimen:
On demand When NRS \>3: Nalbuphine (0.1 mg/kg) will be given with a maximum amount of 20 mg per dose and 160 mg per day.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Patients undergoing unilateral inguinal hernioplasty of ASA less than or equal II.
- Age group: 18-60 years old.
- Patient refusal.
- known allergy to any of the used drugs
- ASA III or above
- Coagulation disorders and thrombocytopenia
- Body mass index (BMI) >30
- Infection at needle insertion site
- Patients undergoing bilateral inguinal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DEX on TAP Dexmedetomidine & Bupivacaine. Group D (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline. KET on TAP ketamine and bupivacaine injection Group B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline. TAP Bupivacaine Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline.
- Primary Outcome Measures
Name Time Method Change in Numeric Pain Rating Scale Immediately postoperative - 2 hours postoperatively - 4 hours postoperatively - 6 hours postoperatively - 12 hours postoperatively The Numeric Pain Rating Scale (NPRS) is an effective method for measuring pain intensity. It consists of an 11-point scale where:
0 represents no pain - 10 represents the worst pain imaginable. Patients are asked to select a whole number that best reflects their pain intensity, typically based on their experience over the last 24 hours or an average pain level.
- Secondary Outcome Measures
Name Time Method Change in Mean arterial blood pressure Immediately postoperative - 2 hours postoperative - 4 hours postoperative MAP = Diastolic Blood Pressure + (1/3 \* Pulse Pressure). It is the average pressure in your arteries throughout one cardiac cycle and will be calculated after measuring the blood pressure of the patients postoperatively.
Trial Locations
- Locations (1)
Ain Shams University Hospitals
🇪🇬Cairo, Egypt
Ain Shams University Hospitals🇪🇬Cairo, EgyptMariam M FouadContact+201274651580mariam.mikhail@med.asu.edu.eg