Cholelithiasis, Postoperative Pain, Laparoscopic Cholecystectomy
Conditions
Keywords
ESP Block, TAP Block, Regional Anesthesia, Ultrasound, Laparoscopic Cholecystectomy, Postoperative Analgesia, Opioid Use
Brief summary
This prospective, randomized, double-blind study compares the analgesic efficacy of ultrasound-guided erector spinae plane (ESP) block and subcostal transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. The primary outcome is 24-hour postoperative opioid consumption. Secondary outcomes include postoperative pain scores, time to first analgesic request, shoulder pain, postoperative nausea and vomiting, and block-related complications.
Detailed description
Postoperative pain remains a significant clinical concern after laparoscopic cholecystectomy despite the minimally invasive nature of the procedure. Inadequate analgesia may delay recovery, increase opioid consumption, and negatively affect patient satisfaction. Regional anesthesia techniques are increasingly incorporated into multimodal analgesia protocols to improve postoperative outcomes and reduce opioid requirements. The erector spinae plane (ESP) block and the subcostal transversus abdominis plane (TAP) block are ultrasound-guided fascial plane blocks commonly used for abdominal surgery. While both techniques have demonstrated analgesic benefits, their comparative effectiveness in laparoscopic cholecystectomy remains uncertain. In particular, differences in visceral pain control, opioid-sparing effect, and shoulder pain incidence require further investigation. This study is designed as a prospective, randomized, double-blind, parallel-group, clinical trial conducted at two tertiary care hospitals in Turkey. Eligible adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned to receive either bilateral ESP block or bilateral subcostal TAP block after induction of anesthesia. Standardized anesthesia and postoperative multimodal analgesia protocols will be applied in both groups to ensure comparability between centers. The primary outcome measure is total opioid consumption within the first 24 postoperative hours, expressed as morphine equivalent dose. Secondary outcome measures include postoperative pain scores assessed using the Numerical Rating Scale (NRS), time to first analgesic request, incidence of shoulder pain, postoperative nausea and vomiting, and block-related complications. Randomization will be performed using a computer-generated sequence, with allocation concealment ensured. Patients and postoperative outcome assessors will be blinded to group assignment. Data will be prospectively recorded and analyzed according to a predefined statistical analysis plan. The findings of this study are expected to provide evidence-based guidance for optimizing regional analgesia strategies in laparoscopic cholecystectomy.
Interventions
PROCEDUREErector Spinae Plane Block
Ultrasound-guided bilateral erector spinae plane block will be performed after induction of general anesthesia. The block will be administered at the appropriate thoracic vertebral level using a standardized volume and concentration of local anesthetic deposited in the fascial plane deep to the erector spinae muscle. The procedure will be performed by experienced anesthesiologists under sterile conditions.
Ultrasound-guided bilateral subcostal transversus abdominis plane block will be performed after induction of general anesthesia. A standardized volume and concentration of local anesthetic will be injected into the fascial plane between the rectus abdominis and transversus abdominis muscles along the subcostal margin. The procedure will be performed by experienced anesthesiologists under sterile conditions.
Sponsors
Gaziantep City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and postoperative outcome assessors will be blinded to group allocation. The regional block will be performed after induction of general anesthesia to maintain participant blinding. Postoperative pain assessments and data collection will be conducted by investigators who are unaware of the assigned intervention. The anesthesiologist performing the block will not be involved in postoperative outcome assessment.
Intervention model description
This study is a prospective, randomized, double-blind, parallel-group clinical trial. Eligible patients undergoing elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned in a 1:1 ratio to receive either bilateral erector spinae plane block or bilateral subcostal transversus abdominis plane block. Randomization will be performed using a computer-generated sequence with allocation concealment. Patients and postoperative outcome assessors will be blinded to group assignment. Standardized intraoperative anesthesia and postoperative multimodal analgesia protocols will be applied in both groups.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years and older Scheduled for elective laparoscopic cholecystectomy under general anesthesia American Society of Anesthesiologists (ASA) physical status I-III Ability to understand the study protocol and provide written informed consent -
Exclusion criteria
Refusal to participate Known allergy or contraindication to local anesthetic agents Coagulopathy or anticoagulant therapy contraindicating regional anesthesia Infection at the planned injection site Body mass index (BMI) \> 35 kg/m² Chronic opioid use or opioid dependence Chronic pain syndromes requiring regular analgesic treatment Severe hepatic, renal, or cardiac dysfunction Pregnancy or breastfeeding Inability to communicate or assess pain using the Numerical Rating Scale (NRS) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption in the First 24 Hours Postoperatively | Within 24 hours after surgery | Total opioid consumption during the first 24 postoperative hours, converted to intravenous morphine equivalent dose (mg), recorded from patient-controlled analgesia devices and supplemental opioid administration. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBekir Suat Kürkçüoğlu
PRINCIPAL_INVESTIGATORBekir Suat Kürkçüoğlu
Gaziantep City Hospital
Outcome results
None listed