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

NCT07203794 | Not Yet Recruiting

• 2 other identifiers: B.30.2.ATA.0.01.00/6162025/2
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain Management; Cholecystectomy, Laparoscopic

Keywords

Laparoscopic Cholecystectomy; Postoperative Pain; Bupivacaine Infiltration; Erector Spinae Plane Block; Intrathecal Morphine; Analgesia; Opioid Consumption

Outcome Measures

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.

  0-24 hours postoperatively

Secondary Outcomes (4)

• Postoperative Pain Scores (Visual Analog Scale, VAS)

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

• Incidence of Postoperative Nausea and Vomiting (PONV)

  0-24 hours postoperatively

• Incidence of Pruritus

  0-24 hours postoperatively

• Incidence of Respiratory Depression

  0-24 hours postoperatively

Study Arms (3)

Bupivacaine Infiltration Group

ACTIVE COMPARATOR

Patients will receive bupivacaine infiltration at the gallbladder bed and trocar sites following laparoscopic cholecystectomy. After removal of the gallbladder, 20 mL of 0.25% bupivacaine will be applied to the gallbladder bed using a sterile sponge for 10-15 minutes. At the end of surgery, a total of 20 mL 0.25% bupivacaine will be infiltrated at trocar insertion sites (8 mL umbilical port, 6 mL epigastric port, 3 mL each auxiliary port).

Drug: Bupivacaine Infiltration

Erector Spinae Plane Block Group

ACTIVE COMPARATOR

Patients will undergo bilateral erector spinae plane block under ultrasound guidance before induction of anesthesia. Under ultrasound guidance at the T7 transverse process level, a total of 40 mL of 0.25% bupivacaine will be injected bilaterally using an in-plane technique prior to induction of anesthesia.

Procedure: Erector Spinae Plane Block

Intrathecal Morphine Group

ACTIVE COMPARATOR

Patients will receive intrathecal morphine prior to induction of anesthesia. With the patient in a sitting position, a 27G spinal needle will be inserted at the L3-L4 interspace, and 200 mcg of morphine will be administered intrathecally before induction of anesthesia.

Drug: Intrathecal Morphine

Interventions

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).

Also known as: Marcaine; Local Infiltration

Bupivacaine Infiltration Group

Erector Spinae Plane Block PROCEDURE

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.

Also known as: ESP Block; Regional Anesthesia

Erector Spinae Plane Block Group

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.

Intrathecal Morphine Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

Location

Related Publications (5)

• Motamed C, Bouaziz H, Franco D, Benhamou D. Analgesic effect of low-dose intrathecal morphine and bupivacaine in laparoscopic cholecystectomy. Anaesthesia. 2000 Feb;55(2):118-24. doi: 10.1046/j.1365-2044.2000.055002118.x.

  PMID: 10651671 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Altuntas G, Akkaya OT, Ozkan D, Sayin MM, Balas S, Ozlu E. Comparison of Intraabdominal and Trocar Site Local Anaesthetic Infiltration on Postoperative Analgesia After Laparoscopic Cholecystectomy. Turk J Anaesthesiol Reanim. 2016 Dec;44(6):306-311. doi: 10.5152/TJAR.2016.75983. Epub 2016 Dec 1.

  PMID: 28058142 BACKGROUND

• Ahmed SM, Shabbir S, Rana NA, Khatoon A, Ghani UF, Basharat I, Khan MN, Hameed FM, Dar MF. Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Cureus. 2024 Oct 9;16(10):e71122. doi: 10.7759/cureus.71122. eCollection 2024 Oct.

  PMID: 39525126 BACKGROUND

• Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.

  PMID: 14667752 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine; Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia; Anesthesia and Analgesia

Study Officials

• Havva Yavuz Kayık, assistant doctor

  Ataturk University Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Central Study Contacts

İrem Ateş, Doçent Doctor

CONTACT

+90 532 740 12 58; driremates@hotmail.com

Mehmet Akif Yılmaz, assistant doctor

CONTACT

+90 534 653 35 39; mehmetakifyilmaz025@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor as the Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 2, 2025
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 2, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)