Clinical trial NCT06342076: Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery
Official title: Comparison of the Efficacy of Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block for Postoperative Analgesia in Major Open Gynaecological Cancer Surgery: a Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Postoperative Complications
Analgesia
Regional Anesthesia Morbidity
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomize study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.

The main question(s) it aims to answer are:

\[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? \] \[Is there a difference in pain scores at 24 hours after surgery? \] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods.

Detailed description: This prospective, randomized study was conducted at Başakşehir Çam and Sakura City Hospital in accordance with the Declaration of Helsinki. After ethics committee approval (decision no: 2023-596, date: 22.11.2023) and written consent from all patients, the study was conducted according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. In the study, which included a total of 50 patients, the patients were divided into two groups: subcostal transversus abdominis plane block (STAPB) or rectus sheath block (RSB). Postoperative 24-hour VAS values, opioid demand and administration amounts in intravenous patient-controlled analgesia, presence of nausea and vomiting, surgical complications and length of hospital stay were evaluated (6th hour, 12th hour, 24th hour).

Eligibility criteria: Inclusion Criteria:

* \>18 years
* ASA II-III

Exclusion Criteria:

* Those who are allergic to local anesthetics
* BMI\> 40 kg/m2
* Those with chronic pain
* Those with a history of previous abdominal surgery
* Patients who refuse the use of postoperative patient-controlled analgesia

Primary outcomes:
measure: visuel analog scale
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: amount of opioid used
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Çam and Sakura City Hospital
state: Basaksehir
Study officials:
References:
citation: Bhatia N, Arora S, Jyotsna W, Kaur G. Comparison of posterior and subcostal approaches to ultrasound-guided transverse abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy. J Clin Anesth. 2014 Jun;26(4):294-9. doi: 10.1016/j.jclinane.2013.11.023. Epub 2014 Jun 2.
citation: Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.
citation: Yorukoglu HU, Sahin T, Oge Kula A. Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Caesarean Delivery: A Randomised Controlled Trial. Turk J Anaesthesiol Reanim. 2023 Feb;51(1):43-48. doi: 10.5152/TJAR.2023.22724.
citation: Soliz JM, Lipski I, Hancher-Hodges S, Speer BB, Popat K. Subcostal Transverse Abdominis Plane Block for Acute Pain Management: A Review. Anesth Pain Med. 2017 Oct 20;7(5):e12923. doi: 10.5812/aapm.12923. eCollection 2017 Oct.
citation: Abdelsalam K, Mohamdin OW. Ultrasound-guided rectus sheath and transversus abdominis plane blocks for perioperative analgesia in upper abdominal surgery: A randomized controlled study. Saudi J Anaesth. 2016 Jan-Mar;10(1):25-8. doi: 10.4103/1658-354X.169470.