Cholecystectomy, Laparoscopic, Postoperative Pain Management
Conditions
Keywords
Laparoscopic Cholecystectomy, Postoperative Pain, Bupivacaine Infiltration, Erector Spinae Plane Block, Intrathecal Morphine, Analgesia, Opioid Consumption
Brief summary
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.
Detailed description
Laparoscopic cholecystectomy is the standard surgical treatment for gallbladder diseases. Despite being a minimally invasive procedure, postoperative pain is a frequent problem and can negatively affect early mobilization, oral intake, and overall recovery. The pain experienced after this surgery is multifactorial, including somatic pain at trocar sites, visceral pain at the gallbladder bed, and shoulder pain caused by carbon dioxide insufflation. Effective pain management is therefore essential to improve patient comfort, reduce opioid consumption, and shorten hospital stay. Several methods are available for postoperative analgesia. Local infiltration of the gallbladder bed and trocar sites with bupivacaine provides targeted pain relief at areas of surgical trauma. Erector spinae plane (ESP) block, a recently described ultrasound-guided regional anesthesia technique, offers both somatic and visceral analgesia with a favorable safety profile. Low-dose intrathecal morphine has also been shown to provide strong and prolonged analgesia in abdominal surgery, though its use may be limited by side effects such as nausea, vomiting, and itching. This single-center, prospective, randomized controlled trial will compare the analgesic efficacy of three techniques: Group INF (Infiltration): Bupivacaine infiltration at the gallbladder bed and trocar sites. Group ESP: Bilateral ultrasound-guided ESP block at the T7 level. Group ITM: Intrathecal morphine administration before induction of anesthesia. The primary outcome is total opioid consumption within the first 24 hours after surgery. Secondary outcomes include postoperative pain scores at multiple time points using the Visual Analog Scale (VAS), as well as the incidence of side effects such as nausea, vomiting, pruritus, and respiratory depression. The results of this study are expected to provide evidence to guide multimodal analgesia strategies in laparoscopic cholecystectomy and to optimize patient recovery and satisfaction.
Interventions
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).
PROCEDUREErector Spinae Plane Block
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.
DRUGIntrathecal Morphine
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.
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and postoperative outcome assessors will be blinded to group allocation. The anesthesiologist performing the intervention cannot be blinded due to the nature of the procedures, but will not be involved in postoperative data collection or outcome assessment. Thus, the trial will be conducted with patient- and assessor-blinding to minimize bias.
Intervention model description
This is a single-center, prospective, randomized, parallel-group, controlled trial with three intervention arms. Eligible patients undergoing elective laparoscopic cholecystectomy will be randomly assigned in a 1:1:1 ratio to receive either bupivacaine infiltration of the gallbladder bed and trocar sites, bilateral ultrasound-guided erector spinae plane block, or intrathecal morphine. Each participant will receive only one of the three interventions in addition to standard general anesthesia and multimodal analgesia. The outcomes will be compared across groups to evaluate the relative analgesic efficacy of the interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * History of neurological or psychiatric disease * Pregnancy * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption in the First 24 Hours | 0-24 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores (Visual Analog Scale, VAS) | At 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours postoperatively | 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. |
| Incidence of Postoperative Nausea and Vomiting (PONV) | 0-24 hours postoperatively | Presence or absence of nausea and vomiting will be recorded to evaluate intervention-related side effects. |
| Incidence of Pruritus | 0-24 hours postoperatively | Occurrence of itching will be recorded as a side effect possibly related to intrathecal morphine. |
| Incidence of Respiratory Depression | 0-24 hours postoperatively | Respiratory depression will be defined as a respiratory rate \< 8 breaths/min or oxygen saturation \< 90% requiring intervention. |
Countries
Turkey (Türkiye)
Contacts
Primary Contactİrem Ateş, Doçent Doctor
Backup ContactMehmet Akif Yılmaz, assistant doctor
Outcome results
None listed