Analgesic EfficacyNCT07075913
Analgesic Efficacy of Adding Dexmedetomidine to Erector Spinae Plane Block Versus Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy
A study testing Subcostal transverse abdominis plane block and Erector spinae plane block in people with Analgesic Efficacy and Dexmedetomidine, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Our scientific work aimed to evaluate the analgesic efficacy of dexmedetomidine as an adjuvant to erector spinae plane block versus subcostal transverse abdominis plane block in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Analgesic Efficacy, Dexmedetomidine, Erector Spinae Plane Block
- What is being tested?
- Subcostal transverse abdominis plane block and Erector spinae plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 May 2025
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 60 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I and II.
- Patients were planned to undergo laparoscopic cholecystectomy.
Who cannot join
- Patient's refusal to participate in the study.
- ASA III, IV.
- History of clinically significant cardiac, hepatic, renal, respiratory or neurological disease.
- Coagulopathy and bleeding disorders.
- Known allergy to any drug included in the study.
- Systemic or local infection at the puncture site.
- Body mass index (BMI) >35 (kg/m2).
- Failed technique.
Trial locations and contacts
1 site in 1 country.
About this study
Our scientific work aimed to evaluate the analgesic efficacy of dexmedetomidine as an adjuvant to erector spinae plane block versus subcostal transverse abdominis plane block in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic cholecystectomy (LC) is the most commonly performed surgical procedure for the management of cholelithiasis. Acute pain after LC consists of somatic, parietal, and referred pain caused by trocar insertion, gall bladder resection, carbon dioxide insufflation, and other factors.
The subcostal transverse abdominis plane (SCTAP) block is the deposition of local anesthetic in the transverse abdominis plane inferior and parallel to the costal margin.
Ultrasound-guided erector spinae plane block (ESPB) is a popular, interfascial regional technique initially described for managing thoracic neuropathic pain.
Dexmedetomidine is an alpha-2 adrenergic receptor agonist that has been the focus of interest due to its sedative, analgesic, perioperative sympatholytic, and cardiovascular-stabilizing effects, resulting in reduced anesthetic requirements.
- Conditions
- Analgesic Efficacy, Dexmedetomidine, Erector Spinae Plane Block, Subcostal Transverse Abdominis Plane Block, Laparoscopic Cholecystectomy
- Being tested
- Subcostal transverse abdominis plane block, Erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal transverse abdominis plane blockOther
Patients received an ultrasound-guided subcostal transverse abdominis plane block with injection of 10 ml bupivacaine 0.25 %, 5ml lignocaine 2 % plus 0.5 μg/kg dexmedetomidine in a 20 ml volume.
Erector spinae plane blockOther
Patients will receive an ultrasound-guided erector spinae plane block (ESPB) with injection of 10 ml bupivacaine 0.25%, 5 ml lignocaine 2 % plus 0.5 μg/kg dexmedetomidine in a 20 ml volume.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients received an ultrasound-guided subcostal transverse abdominis plane block with injection of 10 ml bupivacaine 0.25 %, 5ml lignocaine 2 % plus 0.5 μg/kg dexmedetomidine in a 20 ml volume. Receives: Other: Subcostal transverse abdominis plane block |
| Group II | Experimental | Patients will receive an ultrasound-guided erector spinae plane block (ESPB) with injection of 10 ml bupivacaine 0.25%, 5 ml lignocaine 2 % plus 0.5 μg/kg dexmedetomidine in a 20 ml volume. Receives: Other: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of morphine consumption
If the Visual analogue scale (VAS) is ≥ 3, IV morphine was given as a bolus of 2 mg (body weight < or = 60 kg) or 3 mg (body weight > 60 kg) with 5 minutes' lockout interval.
Measured: 24 hours postoperatively
Secondary outcomes (7)
Heart rate
Heart rate was recorded at baseline, after injection then every 30 minutes till the end of surgery and after surgery at 0, 2, 4, 6, 8, 12, 16 and 24 h.
Measured: 24 hours postoperatively
Mean arterial pressure
Mean arterial pressure was recorded at baseline, after injection then every 30 minutes till the end of surgery and after surgery at 0, 2, 4, 6, 8, 12, 16 and 24 h.
Measured: 24 hours postoperatively
Intraoperative opioid consumption
Intraoperative opioid consumption was recorded.
Measured: Intraoperatively
Time to first rescue analgesia
Time to first rescue analgesia was recorded from the end of surgery till first dose of morphine administrated.
Measured: 24 hours postoperatively
Degree of pain
Visual analogue scale (VAS) was assessed after surgery at 0, 2, 4, 6, 8, 12, 16, 18, and 24 h [where (0 = no pain and 10 = severe pain)].
Measured: 24 hours postoperatively
Incidence of complications
Incidence of complications such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, and failed block were recorded.
Measured: 24 hours postoperatively
Patient satisfaction
Degree of patient satisfaction will be assessed on a 3-point scale; (1= Unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied).
Measured: 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 posted20 Jul 2025
- Study start1 May 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic EfficacyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamees Elsayed Ali Soliman Shaloof, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075913
- Sponsor's protocol ID
- KFSIRB200-624
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.