Subcostal Transversus Abdominis Block Versus Erector Spinae Block in Open Cholecystectomy

NCT ID: NCT06410911

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-07-01

Brief Summary

Open cholecystectomy is a surgical procedure involving the removal of the gallbladder through a traditional, open abdominal incision the surgeon makes an incision in the upper abdomen, exposes the gallbladder, and carefully disconnects and removes it. Postoperative pain management is a critical aspect of patient care following cholecytectomy surgery. Inadequate pain control can lead to a cascade of complications, including atelectasis, pneumonia, and delayed mobilization. These complications can prolong hospital stays, increase healthcare costs, and lead to patient dissatisfaction. Regional anesthesia techniques, such as subcostal transversus abdominis plane (TAP) block abd erector spinae block are commonly used to provide effective analgesia after cholecystectomy surgery. These techniques target the nerves that supply the surgical site, providing pain relief without the need for opioids. Opioids are associated with a number of side effects, including nausea, vomiting, constipation, and respiratory depression. Subcostal TAP block is a relatively new technique that has been shown to be effective in providing postoperative analgesia after upper abdominal surgery. This technique involves injecting local anesthetic into the TAP, a fascial plane that lies between the internal oblique and transversus abdominis muscles. The TAP block provides anesthesia to the nerves that supply the abdominal wall, including the subcostal nerves. Erector Spinae Plane Block is a newer technique targeting the dorsal rami of the T7-T12 spinal nerves, potentially offering broader analgesia encompassing the abdominal wall, thorax, and diaphragm. Early studies suggest improved pain control and respiratory function compared to traditional methods.

Conditions

Post Operative Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group A

subcostal transversus abdominis plane block will be performed 50 patients undergoing open cholecystectomy surgery

Group Type: ACTIVE_COMPARATOR

Subcostal Transversus Abdominis Plane block in patients undergoing open cholecystectomy surgery.

Intervention Type: PROCEDURE

Subcostal Transversus Abdominis Plain block will be performed under ultrasound guidance using a 5-10 MHz linear transducer. The needle will be inserted perpendicular to the skin 2 fingers below the costal

margin, just lateral to the rectus abdominis muscle. After confirming the needle tip's location within the TAP, 20 mL of 0.25% bupivacaine will be injected on both sides in patients undergoing open cholicystectomy surgery.

Sbcostal transversus Abdominis block and erector spinae block for both groups

Intervention Type: DRUG

Each patients group will recieve a type of block by injecting 20 ml of 0.25% bupivacaine on each side in patients undergoing open cholecystectomy

Group B

Ultrasound-guided Erector spinae block will be performed 50 patients undergoing open cholecystectomy surgery

Group Type: ACTIVE_COMPARATOR

Erector Spinae Block in patients undergoing open cholecystectomy

Intervention Type: PROCEDURE

Ultrasound-guided Erector Spinae block using 20 mL of 0.25% bupivacaine will be injected bilaterally at the T7- T8 vertebral level in patients undergoing open cholecystectomy The probe will be advanced 3 cm to the right lateral direction and rotated 90 degrees, and the transverse processes will be determined . Next, 5 mL of 2% lidocaine will be administered to the predicted needle entry point. A 22-gauge, peripheral nerve block needle will cephalocaudally advanced by the in-plane technique. The needle tip will be continuously advanced toward the transverse process to 1-2 mm before contact with the transverse process. After negative aspiration, 20 ml of 0.25% bupivacaine will be injected with intermittent negative aspirations into the fascia of the erector spinae muscle.

Sbcostal transversus Abdominis block and erector spinae block for both groups

Intervention Type: DRUG

Each patients group will recieve a type of block by injecting 20 ml of 0.25% bupivacaine on each side in patients undergoing open cholecystectomy

Interventions

Subcostal Transversus Abdominis Plane block in patients undergoing open cholecystectomy surgery.

Subcostal Transversus Abdominis Plain block will be performed under ultrasound guidance using a 5-10 MHz linear transducer. The needle will be inserted perpendicular to the skin 2 fingers below the costal

margin, just lateral to the rectus abdominis muscle. After confirming the needle tip's location within the TAP, 20 mL of 0.25% bupivacaine will be injected on both sides in patients undergoing open cholicystectomy surgery.

Intervention Type: PROCEDURE

Erector Spinae Block in patients undergoing open cholecystectomy

Ultrasound-guided Erector Spinae block using 20 mL of 0.25% bupivacaine will be injected bilaterally at the T7- T8 vertebral level in patients undergoing open cholecystectomy The probe will be advanced 3 cm to the right lateral direction and rotated 90 degrees, and the transverse processes will be determined . Next, 5 mL of 2% lidocaine will be administered to the predicted needle entry point. A 22-gauge, peripheral nerve block needle will cephalocaudally advanced by the in-plane technique. The needle tip will be continuously advanced toward the transverse process to 1-2 mm before contact with the transverse process. After negative aspiration, 20 ml of 0.25% bupivacaine will be injected with intermittent negative aspirations into the fascia of the erector spinae muscle.

Intervention Type: PROCEDURE

Sbcostal transversus Abdominis block and erector spinae block for both groups

Each patients group will recieve a type of block by injecting 20 ml of 0.25% bupivacaine on each side in patients undergoing open cholecystectomy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 65 years
• Both sex.
• American Society of Anesthesiologists (ASA) I-II Undergoing elective open cholecystectomy surgery.
• Patients who need at least 24hrs hospital admission.

Exclusion Criteria

• Known allergy to local anesthetics
• Coagulopathy or bleeding disorders
• Severe respiratory disease
• Neurological disorders
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Abdellatif Mohamed

assistant lecturer of anaesthia an icu and pain managment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mahmoud A Mohamed, Ass lecturer

Role: CONTACT

dr.mahmoud.abdellatif91@gmail.com

201117521006

Abdelrahman H Abdelrahman, Prof

Role: CONTACT

201120320258

References

Dai L, Ling X, Qian Y. Effect of Ultrasound-Guided Transversus Abdominis Plane Block Combined with Patient-Controlled Intravenous Analgesia on Postoperative Analgesia After Laparoscopic Cholecystectomy: a Double-Blind, Randomized Controlled Trial. J Gastrointest Surg. 2022 Dec;26(12):2542-2550. doi: 10.1007/s11605-022-05450-6. Epub 2022 Sep 13.

Reference Type: BACKGROUND

PMID: 36100826 (View on PubMed)

Viderman D, Aubakirova M, Abdildin YG. Erector Spinae Plane Block in Abdominal Surgery: A Meta-Analysis. Front Med (Lausanne). 2022 Feb 23;9:812531. doi: 10.3389/fmed.2022.812531. eCollection 2022.

Reference Type: BACKGROUND

PMID: 35280917 (View on PubMed)

Other Identifiers

Soh-Med-24-04-01MD

Identifier Type: -

Identifier Source: org_study_id