Analgesic Efficacy of Bupivacaine Infiltration, Erector Spinae Plane Block, and Intrathecal Morphine in Laparoscopic Cholecystectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAtaturk University

About this trial

This study is designed to compare three different methods of pain control after laparoscopic gallbladder surgery (laparoscopic cholecystectomy). Although this surgery is minimally invasive, participants often experience different types of pain after the operation, such as pain at the incision site, pain inside the abdomen, and shoulder pain caused by the gas used during surgery.

The investigators will compare three commonly used pain relief techniques:

Local infiltration - injecting a numbing medicine (bupivacaine) into the gallbladder bed and at the sites where the surgical instruments are placed.

Erector spinae plane (ESP) block - an ultrasound-guided nerve block performed in the back to reduce both abdominal and incisional pain.

Intrathecal morphine - a very small dose of morphine given into the spinal fluid before surgery to provide long-lasting pain relief.

The goal is to determine which method provides the best pain control, reduces the need for opioid medications, and improves recovery after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-65 years

Scheduled for elective laparoscopic cholecystectomy

American Society of Anesthesiologists (ASA) physical status I-III

Able to provide written informed consent

Disqualifiers

Body mass index (BMI) > 35 kg/m²

History of coagulopathy or bleeding disorders

Known allergy or hypersensitivity to opioids or local anesthetics

Chronic pain or regular analgesic use

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine Infiltration

    Drug

    After removal of the gallbladder, 40 mL of 0.25% bupivacaine will be applied to the gallbladder bed with a sterile sponge for 10-15 minutes. At the end of the surgery, 15 mL of 0.25% bupivacaine will be infiltrated into trocar insertion sites (5 mL umbilical port, 5 mL epigastric port, 5 mL each auxiliary port).

  • Erector Spinae Plane Block

    Procedure/Surgery

    Before induction of anesthesia, a bilateral ultrasound-guided erector spinae plane block will be performed at the T7 transverse process level. A total of 40 mL of 0.25% bupivacaine will be injected (20 mL per side) using an in-plane technique under ultrasound guidance.

  • Intrathecal Morphine

    Drug

    With the patient in the sitting position, a 27-gauge spinal needle will be inserted at the L3-L4 interspace. A dose of 100 mcg morphine will be administered intrathecally before induction of anesthesia.

Treatment groups

132 Participants
are divided into 3 treatment groups
Group A: Bupivacaine Infiltration GroupActive comparator 1 intervention
Group B: Erector Spinae Plane Block GroupActive comparator 1 intervention
Group C: Intrathecal Morphine GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Opioid Consumption in the First 24 Hours

The cumulative amount of opioid analgesic (fentanyl via patient-controlled analgesia device) used by each patient during the first 24 hours after laparoscopic cholecystectomy. This measure will evaluate the effectiveness of each intervention in reducing postoperative opioid requirement.

Time frame
0-24 hours postoperatively

Secondary outcomes

1

Postoperative Pain Scores (Visual Analog Scale, VAS)

Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10 ; 0 = no pain, 10 = worst imaginable pain) during active (movement) and passive (rest) conditions.

Time frame
At 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours postoperatively
2

Incidence of Postoperative Nausea and Vomiting (PONV)

Presence or absence of nausea and vomiting will be recorded to evaluate intervention-related side effects.

Time frame
0-24 hours postoperatively
3

Incidence of Pruritus

Occurrence of itching will be recorded as a side effect possibly related to intrathecal morphine.

Time frame
0-24 hours postoperatively
4

Incidence of Respiratory Depression

Respiratory depression will be defined as a respiratory rate \< 8 breaths/min or oxygen saturation \< 90% requiring intervention.

Time frame
0-24 hours postoperatively

Other outcomes

Sponsors and contacts

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