ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000831785

Ethics application status

Approved

Date submitted

21/04/2022

Date registered

14/06/2022

Date last updated

14/06/2022

Date data sharing statement initially provided

14/06/2022

Date results provided

14/06/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Treatment of postoperative pain after laparoscopic cholecystectomy

Scientific title

Comparison of ultrasound guided thoracic paravertebral block and erector spinae plane block for postoperative analgesia after laparoscopic cholecystectomy

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Laparoscopic Cholecystectomy Operations

Postoperative pain

Condition category

Condition code

Anaesthesiology

Pain management

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Thoracic Paravertebral Block: Thoracic paravertebral block is the technique of injecting local anesthetic along side the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramen. This produces unilateral, segmental, somatic, and sympathetic nerve blockade, which is effective for anesthesia and in treating acute and chronic pain of unilateral origin from the chest and abdomen. (https://www.nysora.com/regional-anesthesia-for-specific-surgical-procedures/abdomen/thoracic-lumbar-paravertebral-block/) After the most prominent C7, processus spinosum in the cervical region was determined by palpation with the patients in a sitting position with their head slightly tilted forward, the relevant area was cleaned, we marked caudally one by one under US guidance. And 2,5-3 cm lateral of the T8 spinous process was marked as the injection point. At the needle insertion site, 2 mL of 2% lidocaine was infiltrated into the subcutaneous tissue.
After placing the linear US probe on the marked area for paravertebral block application in the longitudinal plane, consecutive transverse processes and the pleura, superior costotransverse ligament, and paravertebral area were determined. With the in-plane technique, an 80 mm 22 gauge peripheral block needle was directed caudally to the cephalad, and the needle tip was advanced into the thoracic paravertebral area until the superior costotransverse ligament was passed. After confirming there was no vascular interference with aspiration, 2-3 mL of 0,9% saline was administered and ventral movement of the parietal pleura was observed to confirm the needle location, and TPVB was administered by injecting 20 mL of 0.25% bupivacaine .
All TPVBs were performed by an anesthesiologist who has been working for at least 5 years.
The approximate time taken to perform the thoracic paravertebral block is 10 min and performed 10 minutes before commencing surgery. The suitability of the block was evaluated with the loss of cold sensation up and down two levels in the mid-clavicular line.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

Erector Spinae Plane Block: Erector spinae plane block (ESPB) is an interfascial plane block first described in 2016 by Forero et al as an effective treatment method for the treatment of thoracic neuropathic pain. And this block uses for postoperative pain management after laparoscopic surgery. Trapezius, rhomboid, and erector spina muscles and consecutive transverse processes were determined with a linear US probe placed in the longitudinal plane to the area marked. With the in-plane technique, an 80 mm 22 gauge peripheral block needle was directed caudally to the cephalad, and we advanced the needle tip between the anterior fascia of the erector spina muscle group and the vertebral transverse process. After confirming that there was no vascular intervention by aspiration, 2-3 mL of 0.9% saline was administered and simultaneous monitoring of hydro dissection and distribution confirmed the needle location via US, ESPB was administered by injecting 20 mL of 0.25% bupivacaine.
All ESPBs were performed by an anesthesiologist who has been working for at least 5 years. The approximate time taken to perform the thoracic paravertebral block is 10 min and performed 10 minutes before commencing surgery. The suitability of the block was evaluated with the loss of cold sensation up and down two levels in the mid-clavicular line.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome measure of the study was to assess total analgesic drug consumption at the end of the 24 hours assessed using patient medical records.

Timepoint [1]