Rhomboid Intercostal Block vs Erector Spina Plan Block for Peri-operative Analgesia in Mastectomy

Analgesia Clinical Trial

Official title:

Comparison of Rhomboid Intercostal Block and Erector Spina Plan Block for Peri-operative Analgesia in Mastectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04259502
• Other study ID #: 2019/06RIBVSESP
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2020
• Est. completion date: August 2020

Study information

• Verified date: February 2020
• Source: Kutahya Medical Sciences University
• Contact: Onur Balaban, MD.
• Phone: +90 274 231 6660
• Email: obalabandr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effectiveness of erector spinae plane block for analgesia in breast surgery was documented in previous studies. Rhomboid intercostal block may be beneficial for analgesia in breast surgery. The aim of this study is to compare the peri-operative analgesic effect of rhomboid intercostal block with erector spinae plane block in mastectomy operation. This trial was designed as prospective randomized single-blind study. The included patients will be assigned into two groups: RIB-Group where the patients will receive ultrasound-guided rhomboid intercostal block and ESP-Group where the patients will receive ultrasound-guided erector spinae plane block prior to the operation. Primary outcome will be peri-operative pain scores and secondary outcomes will be peri-operative opioid consumption and peri-operative hemodynamic effect of these blocks.

Description:

Postoperative analgesia in breast surgery is important in reducing morbidity and mortality. Intravenous or oral analgesics may be used for this purpose. Ultrasound-guided fascia plane blocks are used to provide effective analgesia in mastectomy operations. Effectiveness of erector spinae plane block for analgesia in breast surgery was documented in previous studies.

Rhomboid intercostal block may be beneficial for analgesia in breast surgery. Both blocks have the advantage of unilateral application in unilateral mastectomy operations. When administered pre-operatively, it also provides per-operative analgesia and may reduce per-operative opioid consumption. These blocks are applied under ultrasound-guidance with single injection. Since the site of injection is relatively superficial (between the back muscles and ribs) and applied under ultrasound-guidance, mechanical complications is expected to occur less. These low-cost blocks also may reduce the usage of high-cost and high-risk opioids after surgery. These blocks unilaterally anesthetize the nerves innervating the thoracic region and the axilla, thus providing effective per-operative and post-operative analgesia in mastectomy operations.

The aim of our study is to compare the rhomboid intercostal block with erector spina plane block in mastectomy in terms of intraoperative and postoperative analgesia in mastectomy operation. Our hypothesis is rhomboid intercostal block may reduce peri-operative pain as effective as or more effectively than erector spina plane block. Secondary hypothesis is rhomboid intercostal block may reduce peri-operative opioid consumption as effective as or more effectively than erector spina plane block. Thus, the study is defined as block technique comparison.

Eighty patients aged between 29-79 years who are planned mastectomy under general anesthesia will be included in the study. Patients with severe cardiac and respiratory disease, severe coagulation disorder, body mass index greater than 35, refusal of regional block and patients having local infection in block application area, contraindication of the standardized drugs in the study and patients with insufficient postoperative analgesia requiring more potent opioids will be excluded from the study.

The patients who meet the study criteria will be assigned into two groups by using computerized randomization. Patients who do not give consent will also be excluded from the study. All patients will be sedated with midazolam and fentanyl prior to block application. First group (RIB-Group) of patients will receive ultrasound-guided rhomboid intercostal block prior to the operation under sedation. Patients in the second group (ESP-Group) will receive ultrasound-guided erector spina plane block under sedation. Since both procedures will be performed from the same site, the study was considered as a single blind.

All patients will be intubated after induction of general anesthesia with Propofol 2 mg / kg, Rocuronium 0.6 mg / kg and Fentanyl 1.5 µg / kg. Mixture of Desflurane 6% concentration in 50% air and 50% oxygen will be used for the maintenance of general anesthesia. Patients in both groups will receive 1 µg / kg of fentanyl when pain occurs during surgery. Pre-operative and post-operative blood pressure, heart rate, oxygen saturation, end-tidal carbon dioxide values of patients in both groups will be measured and recorded at determined time intervals.

Patients will be followed for 48 hours after the operation. In the postoperative period, acetaminophen 1 g three times a day will be administered routinely in context of multimodal analgesia. Intravenous tramadol 1 mg/kg will also be administered depending on patient need up to 4 times a day. Total amount of perioperative opioids will be recorded. Per-operative and post-operative opioid consumption will be calculated separately. Pain assessment will be evaluated by using a verbal analog scale (asking patients to give a pain score between 0 and

10. Score of 0 means worse pain ever and score of 10 means no pain). Complications related to the block procedure will be also recorded. If there is pain that requires more potent opioids such as morphine, the block will be considered as unsuccessful.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Years to 79 Years

Eligibility

Inclusion Criteria:

• Patients who are planned mastectomy under general anesthesia

Exclusion Criteria:

• Patients with severe cardiac and respiratory disease

• Severe coagulation disorder

• Body mass index greater than 35 kg/m2

• Refusal of regional block

• Patients having local infection in block application area

• Contraindication of the standardized drugs in the study

• Insufficient postoperative analgesia requiring more potent opioids

Related Conditions & MeSH terms

• Analgesia
• Perioperative Analgesia
• Postoperative Analgesia

Intervention

Procedure:
• Rhomboid intercostal block
The block is regional anesthesia injection techniques performed under ultrasound guidance.
• Erector spinae plane block
The block is regional anesthesia injection techniques performed under ultrasound guidance.

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University	Kutahya	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Medical Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

Aksu C, Kus A, Yörükoglu HU, Tor Kiliç C, Gürkan Y. Analgesic effect of the bi-level injection erector spinae plane block after breast surgery: A randomized controlled trial. Agri. 2019 Jul;31(3):132-137. doi: 10.14744/agri.2019.61687. — View Citation

Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gümüs Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3. — View Citation

Balaban O, Aydin T. A modified approach of rhomboid intercostal block for postoperative analgesia in modified radical mastectomy: Ultrasound guided bi-level high thoracic injection. J Clin Anesth. 2019 Nov;57:29-30. doi: 10.1016/j.jclinane.2019.03.002. Epub 2019 Mar 6. — View Citation

Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. — View Citation

Gürkan Y, Aksu C, Kus A, Yörükoglu UH, Kiliç CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2. — View Citation

Gürkan Y, Aksu C, Kus A, Yörükoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4. — View Citation

Kimachi PP, Martins EG, Peng P, Forero M. The Erector Spinae Plane Block Provides Complete Surgical Anesthesia in Breast Surgery: A Case Report. A A Pract. 2018 Oct 1;11(7):186-188. doi: 10.1213/XAA.0000000000000777. — View Citation

Selvi O, Tulgar S. Use of the Ultrasound-Guided Erector Spinae Plane Block in Segmental Mastectomy. Turk J Anaesthesiol Reanim. 2019 Apr;47(2):158-160. doi: 10.5152/TJAR.2019.50024. Epub 2019 Jan 29. — View Citation

Singh S, Kumar G, Akhileshwar. Ultrasound-guided erector spinae plane block for postoperative analgesia in modified radical mastectomy: A randomised control study. Indian J Anaesth. 2019 Mar;63(3):200-204. doi: 10.4103/ija.IJA_758_18. — View Citation

Tulgar S, Selvi O, Thomas DT, Manukyan M, Özer Z. Rhomboid intercostal block in a modified radical mastectomy and axillary curettage patient; A new indication for novel interfascial block. J Clin Anesth. 2019 May;54:158-159. doi: 10.1016/j.jclinane.2018.12.006. Epub 2018 Dec 13. — View Citation

Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Subjective pain score reported by the patient, assessed by a blinded investigator to the study; which is defined as the score in a scale between minimum value of zero and maximum value of 10 (higher scores mean a better outcome).	Throughout post-operative course, up to 48 hours
Primary	Peroperative Analgesia	Fentanyl consumption	At the end of the operation
Secondary	Opioid consumption	Total tramadol consumption	48th postoperative hour