Acut Postoperative PainNCT07504705
Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients
A study testing Intertransverse Process Block and Erector Spinae Plane Block in people with Acut Postoperative Pain and Erector Spinae Plane Block, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is considered the gold standard for the surgical treatment of benign gallbladder diseases; however, despite its minimally invasive nature, a significant proportion of patients experience substantial early postoperative pain, which impacts patient comfort and the duration of hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acut Postoperative Pain, Erector Spinae Plane Block, Intertransverse Process Block
- What is being tested?
- Intertransverse Process Block and Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2026to 1 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective laparoscopic cholecystectomy
- Body mass index (BMI) between 18 and 35 kg/m²
- American Society of Anesthesiologists (ASA) physical status score of I-III
- Ability to provide written and verbal informed consent
Who cannot join
- Coagulopathy or use of anticoagulant medications
- Infection at the injection site
- Allergy to local anesthetics
- Pregnancy or breastfeeding
- Chronic opioid use or analgesic dependence
- Severe cardiopulmonary disease or psychiatric disorders
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- Previous regional block performed within the last 24 hours
- Patients requiring emergency surgery
- Cases converted from laparoscopic surgery to open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients: A Multicenter Randomized Controlled Trial
Laparoscopic cholecystectomy is considered the gold standard for the surgical treatment of benign gallbladder diseases; however, despite its minimally invasive nature, a significant proportion of patients experience substantial early postoperative pain, which impacts patient comfort and the duration of hospital stay. The current PROSPECT review and previous studies emphasize that this pain is multifactorial-comprising somatic, visceral, and phrenic nerve-mediated shoulder-tip components-and therefore advocate for an opioid-sparing multimodal analgesic approach. Within this framework, first-line recommendations include paracetamol, NSAIDs/COX-2 inhibitors, dexamethasone, and local anesthetic infiltration of the surgical site and/or intraperitoneal cavity, alongside appropriate regional blocks; opioids should be reserved solely for rescue analgesia.
Ultrasound-guided regional anesthesia blocks are increasingly utilized for acute visceral pain conditions, such as renal colic. The Erector Spinae Plane Block (ESPB) is an interfacial block performed in the thoracic paraspinal region, and it is hypothesized that its extensive spread may influence somatic and, to some extent, visceral pain pathways. Nevertheless, anatomical and clinical studies report inconsistent effects of ESPB on visceral pain, noting that local anesthetics may not consistently reach the paravertebral space, thereby leading to variable block efficacy.
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Consequently, the Intertransverse Process Block (ITPB), which targets a plane anatomically closer to the paravertebral space, has been described in recent years as an alternative technique. ITPB is performed by injecting local anesthetic into the interfacial space adjacent to the retro-superior costotransverse ligament; it is reported to carry a low risk of complications as it does not require direct orientation toward the pleura or neuraxial structures. Clinical trials indicate that ITPB provides analgesic efficacy comparable to paravertebral blocks in both thoracic and abdominal surgeries and reduces opioid consumption. Furthermore, anatomical studies suggest that the probability of local anesthetic spread into the paravertebral space is higher with ITPB than with ESPB.
However, a randomized controlled trial comparing ESPB and ITPB in patients undergoing laparoscopic cholecystectomy is currently lacking in the literature. Therefore, the present study was designed to address this gap.
- Being tested
- Intertransverse Process Block, Erector Spinae Plane Block
- Keywords
- Laparoscopic Cholecystectomy, Erector Spinae Plane Block, Intertransverse Process Block, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intertransverse Process BlockProcedure or surgery
The ITPB will be performed using the same ultrasound (US) device. Initially, the spinous process of the T8 vertebra will be visualized in the horizontal plane at the midline using a linear probe. The probe will then be shifted approximately 2 cm laterally to the right and left of the midline in the longitudinal plane to visualize the superior costotransverse ligament (SCTL) spanning between the transverse processes and the pleura. The block needle will be advanced in-plane in a caudal-to-cranial direction, parallel to the SCTL, and stopped just before reaching the cranial aspect of the eighth rib. After the space is confirmed via hydrodissection, 20 mL of 0.5% bupivacaine (not exceeding a maximum dose of 2.5 mg/kg) will be injected without penetrating the SCTL, while simultaneously monitoring the volume spread via US. The block will be performed unilaterally at the level of the right hemithorax.
Erector Spinae Plane BlockProcedure or surgery
The ESPB will be performed in the sitting position under ultrasound (US) guidance using a 6-10 MHz linear ultrasound probe (Mindray DC-60 Exp; Mindray Bio-Medical Electronics, Shenzhen, China). The transverse process and erector spinae muscles at the T8 level will be visualized in a longitudinal parasagittal plane. An echogenic 22 G, 80 mm needle (Stimuplex A, B. Braun, Melsungen, Germany) will be advanced in-plane in a caudal-to-cranial direction until contact is made with the transverse process beneath the erector spinae muscle. Following negative aspiration, 20 mL of 0.5% bupivacaine will be injected, ensuring visualization of the spread within the fascial plane. The block will be performed unilaterally on the right hemithorax.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Not described Receives: Procedure: Erector Spinae Plane Block |
| Intertransverse Process Block | Active comparator | Not described Receives: Procedure: Intertransverse Process Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS Score
The primary objective of this study is to compare the effects of ESPB and ITPB techniques on Numeric Rating Scale (NRS) pain scores in patients undergoing laparoscopic cholecystectomy. You hypothesis is that NRS scores will be lower in patients receiving ITPB compared to the ESPB group, as the ITPB is expected to provide more extensive visceral analgesia. Pain Assessment: Numeric Rating Scale (NRS)
Pain intensity will be reported using the Numeric Rating Scale (NRS):
Scale Range: Scores range from a minimum of 0 to a maximum of 10.
Interpretation: A score of 0 represents "no pain," while a score of 10 represents the "worst possible pain." Consequently, higher scores indicate a worse outcome (increased pain severity), while lower scores indicate superior analgesic efficacy.
Measured: 0 to 24 hours postoperatively
Secondary outcomes (1)
Opioid consumption
The secondary objective of the study is to evaluate the effects of ESPB and ITPB on opioid consumption. The amounts of rescue analgesic (tramadol) administered in the post-block period will be recorded. You hypothesis is that opioid requirements will be lower in patients receiving ITPB compared to the ESPB group, due to the provision of more effective analgesia.
Measured: 0 to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start7 May 2026
- Primary completion17 Oct 2026
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acut Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups to receive either an ultrasound-guided intertransverse process block (ITPB) or an erector spinae plane block (ESPB). Each participant will receive only one intervention, and postoperative outcomes will be compared between the two groups. This study aims to provide a 'head-to-head' comparison between these two active regional anesthesia techniques.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Keklicek, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504705
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/141
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No