Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Turkey (Türkiye)
NCT Number: NCT07834086
This prospective, single-center observational study will evaluate postoperative analgesia in adults undergoing elective laparoscopic cholecystectomy. Participants will receive routine anesthetic care selected by the responsible anesthesiologist and will be observed in one of three groups: rectointercostal plane block, external oblique-rectus abdominis plane (EXORA) block, or intravenous patient-controlled analgesia (IV PCA). The study will compare postoperative pain scores and sensory block spread. Pain at rest and with movement will be assessed using the 0-to-10 Numeric Rating Scale at 0, 2, 4, 6, 12, and 24 hours after surgery. Sensory spread will be assessed by pinprick testing across the T4-T12 dermatomes at 30 minutes after surgery. Additional assessments will include 24-hour tramadol consumption, postoperative nausea and vomiting, and block-related complications.
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Notify Me18 year–85 year
All sexes
Observational
Bursa, Turkey (Türkiye)
The study will prospectively enroll 90 adults aged 18 to 85 years who are scheduled for elective laparoscopic cholecystectomy at Bursa Yuksek Ihtisas Training and Research Hospital. The choice of postoperative analgesic technique will be made by the responsible anesthesiologist as part of routine clinical care; the investigators will not assign participants to an analgesic technique. Participants will be evaluated according to the routine care they receive: rectointercostal plane block, EXORA block, or intravenous patient-controlled analgesia. Investigators will record demographic and clinical characteristics, operative and anesthetic information, the analgesic technique used, local anesthetic type and volume when applicable, and tramadol use. Pain at rest and during movement will be measured with the Numeric Rating Scale at 0, 2, 4, 6, 12, and 24 hours postoperatively. For participants receiving a plane block, dermatomal sensory spread from T4 through T12 will be assessed by pinprick testing at 30 minutes after surgery. The study will also record cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and block-related complications.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided rectointercostal plane block used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care.
Ultrasound-guided external oblique-rectus abdominis plane (EXORA) block used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care.
Other names: EXORA Block
Intravenous patient-controlled analgesia with tramadol used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care.
Other names: IV PCA With Tramadol
Time frame: 0, 2, 4, 6, 12, and 24 hours after surgery
Participant-reported pain intensity will be measured separately at rest and during movement using an 11-point Numeric Rating Scale ranging from 0 to 10, with higher scores indicating greater pain.
Time frame: 30 minutes after surgery
In participants who receive a plane block, sensory block distribution will be assessed by pinprick testing across the T4 through T12 dermatomes. Dermatomes demonstrating reduced pinprick sensation will be recorded.
Time frame: During the first 24 hours after surgery
Total tramadol consumption, measured in milligrams, will be recorded during the first 24 postoperative hours.
Time frame: During the first 24 hours after surgery
The number and percentage of participants who experience postoperative nausea and/or vomiting will be recorded.
Time frame: During the first 24 hours after surgery
Among participants who receive a plane block, the number and percentage who experience any complication considered related to the block procedure will be recorded.
Bursa Yuksek Ihtisas Training and Research Hospital
Other Gov
Postoperative Analgesic Effectiveness of Superficial Plane Blocks in Laparoscopic Cholecystectomy: A Prospective Observational Study
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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.
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