Anesthesia, Local, Cholecystectomy, Laparoscopic, Cholelithiasis, Nerve Block, Pain, Postoperative
Conditions
Keywords
Laparoscopic cholecystectomy, unilateral transversus abdominis plane block, local anesthetic infiltration, postoperative pain management, regional anesthesia
Brief summary
This study compared different methods of pain control after laparoscopic gallbladder removal. A total of 160 patients were randomly assigned to receive either a unilateral laparoscopic TAP block, local anesthetic infiltration, a combination of both, or no regional anesthesia. Pain scores, use of pain medication, and complications were measured up to 24 hours after surgery. The TAP block group experienced less pain and fewer wound-related problems, showing that this method is safe and effective for postoperative pain relief.
Detailed description
Gallbladder stones are a common condition, and laparoscopic cholecystectomy is the standard treatment. Effective pain control after surgery is important for recovery and patient comfort. Traditionally, local anesthetic infiltration (LAI) at the surgical wound sites is used. Another method, the transversus abdominis plane (TAP) block, may provide better pain relief. This prospective, randomized clinical trial was conducted at the University Clinical Hospital in Olsztyn, Poland. A total of 160 patients undergoing elective laparoscopic cholecystectomy were randomized into four groups: TAP block, LAI, TAP+LAI, and control. All patients received the same type of anesthesia and standard pain medications. The primary goal was to compare pain intensity within 24 hours after surgery using the Numerical Rating Scale (NRS). Secondary measures included use of additional painkillers, recovery scores (Aldrete), and possible complications at the wound site. The influence of surgical drains and gallstone size on pain was also examined. The study found that the unilateral laparoscopic TAP block provided the best pain relief, fewer wound-related complications, and reduced need for additional medications compared with other methods. These results suggest that the laparoscopic TAP block is a safe and effective option for improving postoperative pain management after gallbladder surgery.
Interventions
PROCEDUREUnilateral laparoscopic TAP block (0.25% bupivacaine)
Injection of 20 mL 0.25% bupivacaine into the transversus abdominis plane under direct laparoscopic vision.
PROCEDURELocal anesthetic infiltration (0.25% bupivacaine)
Injection of 20 mL 0.25% bupivacaine distributed across trocar insertion sites under laparoscopic guidance.
PROCEDURECombined TAP block and local anesthetic infiltration (0.25% bupivacaine)
10 mL of 0.25% bupivacaine given as a TAP block and 10 mL administered as local infiltration at trocar sites.
Sponsors
University of Warmia and Mazury in Olsztyn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients were blinded to group allocation. The statistician analyzing the results was also blinded. Care providers performing the procedures were not blinded.
Intervention model description
Participants were randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: 1. unilateral laparoscopic TAP block, 2. local anesthetic infiltration (LAI), 3. combined TAP+LAI, 4. control (no regional anesthesia). Each participant remained in the assigned group throughout the study.
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 20 to 85 years * Scheduled for elective laparoscopic cholecystectomy for symptomatic cholelithiasis confirmed by ultrasonography * American Society of Anesthesiologists (ASA) physical status I-II * Provided written informed consent
Exclusion criteria
* ASA physical status III-IV * Contraindications to laparoscopy * Acute cholecystitis diagnosed preoperatively or perioperatively * Chronic analgesic use * Spinal degenerative joint disease * Known allergy to local anesthetics * Opioid or alcohol dependence * Psychiatric or neurological disorders * Lack of consent or withdrawal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured by Numerical Rating Scale (NRS) at 2, 6, and 24 hours after laparoscopic cholecystectomy | Pain scores were recorded at 2 hours, 6 hours, and 24 hours after laparoscopic cholecystectomy during the first postoperative day. | Pain intensity was assessed using the Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Scores were recorded by patients at rest at three time points after laparoscopic cholecystectomy: 2 hours, 6 hours, and 24 hours postoperatively. Pain was evaluated as an overall score and at specific surgical sites (umbilical, subcostal, and substernal wounds). Assessments were performed only when patients reached an adequate level of consciousness, verified by Aldrete score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of rescue analgesics (metamizole, paracetamol, oxycodone) within 24 hours after laparoscopic cholecystectomy | Rescue analgesic use assessed at 6, 12, 18, and 24 hours after surgery during the first postoperative day. | Rescue analgesic use was recorded for each participant during the first 24 hours after laparoscopic cholecystectomy. Medications included metamizole, paracetamol, and oxycodone, administered according to standardized postoperative pain protocols: metamizole at 6, 12, 18, and 24 hours unless NRS ≤1, paracetamol if NRS \>4, and oxycodone if NRS \>6. The number and percentage of patients requiring each medication at 6, 12, 18, and 24 hours postoperatively were analyzed. |
Countries
Poland
Outcome results
None listed