Koc University Hospital
Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)
Location contact
Muhammet Selman Söğüt, MD
CONTACT
Rafet Onur Görgülü, MD
CONTACT
NCT Number: NCT07759570
Coronary artery bypass graft (CABG) surgery performed via sternotomy (incision of the breastbone) can cause severe pain after surgery; this can slow recovery and increase the need for opioid pain relievers. This study investigates whether placing a catheter to deliver a local anesthetic to the superficial parasternal intercostal plane reduces pain following this type of heart surgery. Patients undergoing CABG via sternotomy will be randomly assigned to either the catheter-based analgesia group or the standard pain management group. The researchers will compare postoperative pain levels and analgesic medication requirements between the two groups to determine whether this technique improves postoperative pain control.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)
Muhammet Selman Söğüt, MD
CONTACT
Rafet Onur Görgülü, MD
CONTACT
Patients undergoing coronary artery bypass surgery will be included. Patients will be divided into two groups: the block group, in which a bilateral superficial parasternal plexus catheter will be inserted, and the control group, in which no parasternal plexus block or catheter will be administered.
In the block group, the catheter placement will be performed after completion of the surgery and before the patient is transferred to the ICU, under ultrasound guidance (Venue Go, GE, L4-T12 high-frequency linear probe). The probe will be positioned transversely across the costal cartilage, parallel to the sternum, in a parasagittal orientation at the level of 3rd rib. A 5-cm Tuohy needle will be inserted 2 cm lateral to the midline and advanced between the pectoralis major and external intercostal muscles at the third parasternal intercostal space. Needle tip position will be confirmed by negative aspiration for blood or air, followed by injection of 20 mL of bupivacaine 0.2% into the parasternal plane. Correct needle position will be confirmed by visualization of local anesthetic spread and hydrodissection separating the pectoralis major from the ribs and external intercostal muscles. A catheter (Tuohy Ultra-360 18G, B. Braun Contiplex, 400 mm) will then be placed into the parasternal intercostal space. Catheter position will be confirmed by ultrasound visualization of spread of 10 mL saline, after which the catheter will be secured. The procedure will be performed bilaterally. Postoperatively, 20 mL of bupivacaine 0.2% will be administered by the clinician through each parasternal catheter at 12, 24, 36, 48, 60, and 72 hours. Catheters will be removed by the clinician at 72 hours. Catheter-related complications, including bleeding, infection, and dislocation, will be recorded.
In the control group, no parasternal plexus block or catheter will be placed.
Intraoperative anesthesia technique will be identical in both groups. All patients will be admitted to the ICU orotracheally intubated and will be extubated in the ICU rather than in the operating room.
Pain nurses will assess all patients every 12 hours for 72 hours postoperatively. At each visit, pain score will be recorded using the Visual Analog Scale, where 0 corresponds to no pain and 10 corresponds to worst pain, assessed both at rest and during movement. Postoperative opioid consumption will be monitored via a patient-controlled analgesia device. The Morphine PCA solution will be prepared at a concentration of 1 mg/mL, with no background infusion, a bolus dose of 1 mL, and a lockout interval of 15 minutes. Additional (rescue) opioid analgesic requirements will be recorded by pain monitoring nurses. Rescue analgesia in both groups will consist of tramadol 1 mg/kg administered intravenously.
Patients' heart rhythm will be monitored continuously via telemetry throughout their hospital stay. Atrial tachyarrhythmias, including atrial flutter and atrial fibrillation, will be recorded throughout the hospital stay. Nausea, vomiting, and constipation will be recorded for 72 hours postoperatively.
Patient satisfaction will be assessed using a 5-point Likert scale, where 1 corresponds to strongly not satisfied and 5 corresponds to strongly satisfied. Hospital length of stay, ICU length of stay, and time to extubation in the ICU will be recorded for both groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bilateral superficial parasternal block catheters will be placed at the end of the surgery, at the level of 3rd rib using ultrasound guidance
Time frame: Postoperative 24 hours
Cumulative opioid consumption (patient controlled analgesia and rescue analgesia) at the first 24 hours postoperatively
Time frame: at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Resting pain levels of patients will be evaluated using the numeric rating scale where 0 point meaning no pain and 10 points meaning the worst pain possible
Time frame: at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Pain levels associated with cough of patients will be evaluated using the numeric rating scale where 0 point meaning no pain and 10 points meaning the worst pain possible
Time frame: at the first 72 hours after surgery
Time frame: The patient will be monitored for the first 72 hours after surgery.
The time when rescue analgesia is first administered during the postoperative recovery period
Time frame: From intensive care unit admission until extubation, assessed up to 72 hours after intensive care unit admission
It will be recorded as postoperative minutes.
Time frame: From intensive care unit admission until ICU discharge, assessed up to 14 days after intensive care unit admission
Time frame: From surgery until hospital discharge, assessed up to 30 days after intensive care unit admission
Time frame: at the 72nd hour postoperatively
Patients will be asked "How satisfied are you with your pain treatment" at 72 hours after surgery. A numeric rating scale will be used where 0 point meaning not satisfied at all and 10 points meaning can not be satisfied more.
Time frame: for 72 hours after surgery
Time frame: for 72 hours after surgery
Time frame: for 72 hours after surgery
Postoperative time to first bowel movement (defecation or flattus)
Time frame: During the first 72 hours after surgery
Patients will be monitored via telemetry during their discharge period.
Time frame: From the end of the surgery until hospital discharge, assessed up to 30 days after surgery
Time frame: During the first 72 hours after surgery
After the catheter is placed using ultrasound, the catheter site will be verified with saline.
Koc University Hospital
Other
The Effect of Superficial Parasternal Intercostal Plane Catheter Analgesia Following Sternotomy in Coronary Artery Bypass Surgery on Postoperative Pain: A Prospective Randomized Controlled Trial
Acronym: PIP-PAIN
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.
NCT07711457
Arterial Occlusive Diseases, Augmented Reality
Taipei, Taiwan
View Trial DetailsNCT06449599
Anesthesia, Arrhythmias, Cardiac
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07760207
Agnosia, Nervous System Diseases
View Trial DetailsNCT07643792
Fascia Iliaca Block, Hip Surgery
Beijing, Beijing Municipality, China
View Trial Details