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The Efficacy of Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia of Patients Undergoing Laparoscopic Cholecystectomy

The Efficacy of Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia of Adult Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double Blinded Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001106224
Acronym
US-ESP for Cholecystectomy
Enrollment
41
Registered
2018-07-03
Start date
2018-07-06
Completion date
2018-07-27
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Our primary aims are to assess the effects of US-ESP on postoperative pain scores and opioid consumption after laparoscopic cholecystectomy surgery. Our hypothesis is that US-ESP will reduce postoperative pain scores and opioid consumption of the patients more significantly than control group. Our secondary aims are to assess the intraoperative fentanyl need and postoperative shoulder pain of the groups. Our hypothesis is that the fentanyl need and shoulder pain in ESP group will be lower than control group.

Interventions

n the operating room (OR), all of the patients will receive a standard monitoring including electrocardiography, non-invasive blood pressure, peripheral oxygen saturation and bi-spectral index monitoring. After the placement of a 22-gauge intraveous line, 15 ml kg-1 isotonic saline infusion will be started. All patients will receive intravenous 0.05 midazolam for sedation. Then the patients will randomly divided into two groups based on a computerized randomization table created by a researcher

n the operating room (OR), all of the patients will receive a standard monitoring including electrocardiography, non-invasive blood pressure, peripheral oxygen saturation and bi-spectral index monitoring. After the placement of a 22-gauge intraveous line, 15 ml kg-1 isotonic saline infusion will be started. All patients will receive intravenous 0.05 midazolam for sedation. Then the patients will randomly divided into two groups based on a computerized randomization table created by a researcher who will not involve in the study. There will be two anesthesiologists in the OR. For each randomized patient, the first anesthesiologist will take the corresponding sealed envelope from a folder, which indicates the treatment assigned to the patient, while the second anesthesiologist will be blind to the group allocations. The first anesthesiologist will prepare the drug solutions for use in the study (0.25% bupivacaine or isotonic saline solution) in two identical 20 ml syringes and a 10 ml syringe of isotonic saline for hydrodissection and pass the labeled syringes to the blinded anesthesiologist. And the patients will be placed in sitting position. In the first group (Group US-ESP), the second anesthesiologist will locate the ultrasound probe in longitudinal orientation at the level of T7 spinous process and then place 3 cm laterally from the midline. The ultrasound landmarks, T7 transverse process and the overlying erector spinae muscle, will be identified. Under aseptic conditions, a 80 mm 21-gauge block needle will be inserted in-plane at an angle of 30-40 degrees in cranial-to-caudal direction until the tip contacts the T7 transverse process. After the hydrodissection with 3 mL of isotonic saline solution confirmes correct needle tip position, the anesthesiologist will inject 20 mL of 0.25% bupivacaine deep to the erector spinae muscle. The same procedure will be repeated with 20 mL of 0.25% bupivacaine solution at the contralateral side. The block procedure will take approximately 10-15 minutes and then the anesthesiologists will start induction of anesthesia with intravenous propofol, fentanyl and rocuronium bromide.

Sponsors

Basak ALTIPARMAK
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

The patients between 18-70 years of age with ASA status I-II, and scheduled for an elective laparoscopic cholecystectomy surgery,

Exclusion criteria

The patients with coagulation disorder, known allergy to local anesthetics, infection at the injection site, advanced hepatic or renal failure, chronic opioid consumption and morbid obesity (body mass index over 35 kg m-2)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026