Clinical trial NCT05901129: The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Shoulder Surgery
Official title: The Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Keywords: serratus posterior superior intercostal plane block
postoperative pain
shoulder surgery
regional anesthesia
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aim is to assess the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing shoulder surgery.

Detailed description: There were three randomized groups: Group 1 (no block-control group, n=12) Group 2 (SPSIPB-2nd rib targetted, n=12), Group 3 (SPSIPB-3rd rib targetted, n=12). All patients had standard general anesthesia. Group 2 and Group 3 had serratus posterior superior intercostal plane block (SPSIPB) with 0.25% bupivacaine (total volume of 30 ml) before the surgery. Local anesthetic was injected between 2nd rib an serratus posterior superior muscle in Group 2 and it was injected between 3rd rib and same muscle in Group 3. All patients had 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients had ibuprofen 3x400 mg in postoperative 24 hours. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol was administered as a rescue analgesic in all patients.Total tramadol consumption was calculated.

Eligibility criteria: Inclusion Criteria:

* Adult patients older than 18 years of age who underwent open or arthroscopic shoulder surgery under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment

Primary outcomes:
measure: Numerical rating scale (NRS) scores
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Total tramadol consumption
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
name: Oğuz Gündoğdu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.