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

NCT ID: NCT07203794

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-04-02

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.

Conditions

Postoperative Pain Management; Cholecystectomy, Laparoscopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bupivacaine Infiltration Group

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).

Group Type: ACTIVE_COMPARATOR

Bupivacaine Infiltration

Intervention Type: 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 Group

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.

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type: 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.

Intrathecal Morphine Group

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.

Group Type: ACTIVE_COMPARATOR

Intrathecal Morphine

Intervention Type: 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.

Interventions

Bupivacaine Infiltration

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).

Intervention Type: DRUG

Erector 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.

Intervention Type: PROCEDURE

Intrathecal 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.

Intervention Type: DRUG

Other Intervention Names

Marcaine; Local Infiltration; ESP Block; Regional Anesthesia

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

irem ateş

Associate Professor as the Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Havva Yavuz Kayık, assistant doctor

Role: STUDY_DIRECTOR

Ataturk University Department of Anesthesiology and Reanimation

Locations

Ataturk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

İrem Ateş, Doçent Doctor

Role: CONTACT

driremates@hotmail.com

+90 532 740 12 58

Mehmet Akif Yılmaz, assistant doctor

Role: CONTACT

mehmetakifyilmaz025@gmail.com

+90 534 653 35 39

Facility Contacts

Mehmet Akif Yılmaz, assistant doctor

Role: primary

mehmetakifyilmaz025@gmail.com

+90-534-653-35-39

References

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.

Reference Type: BACKGROUND

PMID: 10651671 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27501016 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28058142 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39525126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14667752 (View on PubMed)

Other Identifiers

2025/2

Identifier Type: OTHER

Identifier Source: secondary_id

B.30.2.ATA.0.01.00/616

Identifier Type: -

Identifier Source: org_study_id