Comparison between pain control techniques, viz, injection of drug in the lower back, ultrasound-guided injection of drug in the upper back and patient-controlled pain management in breast cancer surgery

Phase 2

Recruiting

Conditions: Malignant neoplasm of breast of unspecified site,

Registration Number: CTRI/2020/09/027756

Lead Sponsor: All India Institute of Medical Sciences

Brief Summary: Modified radical mastectomy (MRM) is usually associated with severe post-operative pain and restricted shoulder mobility (1-2). General anesthesia is currently the standard technique used to facilitate MRM but the drawbacks include, but not limited to, inadequate pain control due to lack of residual analgesia, high incidence of nausea and vomiting and increased length of hospital stay (3). Regional analgesia techniques can help in reducing incidence of postsurgical chronic pain (4) as well as cancer recurrence in oncological breast surgeries (5). Although these regional techniques provide varying degree of analgesia, each one is associated with its inherent disadvantages such as failure, limited duration of action, requirement of expertise or specific skills like knowledge of sonoanatomy and ultrasound use, instruments and time, and complications like pneumothorax, vascular puncture and injury to nerves (6).

Erector spinae plane block (ESPB) is one of the newest techniques to be described. ESPB is easy to perform and has low rate of complications (7). However, despite the effectiveness of the technique, further studies are necessary to obtain more evidence of its actions (8).

Intrathecal (IT) opioid administration is commonly used for abdominal and even thoracic surgeries as this procedure is simple, quick, easy to perform and carries a relatively low risk of technical complications or failure. Mazy et al used 25mcg intrathecal fentanyl injected at the lumbar level with 20mg bupivacaine for patients undergoing mastectomy, and reported significant reduction in in 24-hour analgesic requirement and improved range of arm movement (9).

The use of IT opioid especially morphine as an analgesic technique in breast cancer surgeries has not yet been explored. So, we plan to study the post-operative pain parameters, opioid-sparing effect, duration of analgesia and patient satisfaction score between MRM patients receiving intrathecal morphine, those receiving ESPB and those receiving PCA fentanyl alone.

Method: The sample size will be taken as 60 patients, 20 in each group. The patients fulfilling the inclusion criteria will be assigned to three different groups by computer generated random numbers and sequentially numbered opaque sealed envelope technique (SNOSE), namely:

Group A: Intrathecal morphine group

Group B: Erector spinae plane block group

Group C: Control group

On reaching the Operation Room, standard monitors will be attached and intravenous access will be secured. All patients will be given prophylaxis for nausea, vomiting and anxiety. Patients of all groups will receive general anesthesia for the surgery and hemodynamic monitoring will be done vigilantly.

On arriving at Post-anesthesia Care Unit (PACU), device for PCA fentanyl administration will be given to all the patients. Monitors will be attached for hemodynamic monitoring at specific times for the first 24 hours and PCA fentanyl consumption for the 24 hours in the post-operative period will be recorded. Pain will be managed as per standard protocol and in case of severe pain rescue analgesia wll be given. The time to first analgesic requirement by the patient will be recorded, monitored for pain on movement, satisfaction score at the end of first 24 hours will be recorded. In addition, adverse events like nausea, vomiting, respiratory depression will be monitored for and managed accordingly.

References:

1) Ghoncheh M, Pournamdar Z, Salehiniya H. Incidence and Mortality and Epidemiology of Breast Cancer in the World. Asian Pac J Cancer Prev. 2016;17(S3):43-6.

2) Fecho K, Miller NR, Merritt SA, Klauber-Demore N, Hultman CS, Blau WS. Acute and persistent postoperative pain after breast surgery. Pain Med. 2009 Jun;10(4):708-15.

3) Oddby-Muhrbeck E, Jakobsson J, Andersson L, Askergren J. Postoperative nausea and vomiting. A comparison between intravenous and inhalation anesthesia in breast surgery. Acta Anaesthesiol Scand. 1994 Jan;38(1):52-6.

4) Kairaluoma PM, Bachman MS, Rosenberg PH, Pere PJ. Preincisional paravertebral block reduces the prevalence of chronic pain after breast surgery. Anesth Analg. 2006 Sep;103(3):703-8.

5) Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic technique for primary breast cancer surgery affect recurrence or metastasis? Anesthesiology. 2006 Oct;105(4):660-4.

6) Bolin ED, Harvey NR, Wilson SH. Regional anesthesia for breast surgery: techniques and benefits. Curr Anesthesiol Rep 2015;5:217-224.

7) Bartakke AA, Varma MK. Analgesia for Breast Surgery - A Brief Overview. www.wfsahq.org, Anesthesia Tutorial Of The Week 403.

8) Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, et al. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019;72(3):209-20.

9) Mazy AEMA, Saber HIE. Potential analgesia of lumbar intrathecal fetanyl in breast cancer surgery. Research and Opinion in Anesthesia & Intensive Care 2018, 5:220-5.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 60

Inclusion Criteria

ASA I-II patients scheduled to undergo elective modified radical mastectomy.

Exclusion Criteria

Patient refusal for regional techniques 2) All contra-indications to regional techniques: a) Local or systemic infection b) Known allergy to the study drugs c) Bleeding disorders d) Platelet count <80,000/Î¼L of blood 3) BMI > 35 4) Inability to use PCA device post operatively.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-hour fentanyl consumption	From arrival in post-anesthesia care unit to 24 hours post-operatively

Secondary Outcome Measures

Name	Time	Method
Time to first analgesic requirement	From arrival in post-anesthesia care unit to 24 hours post-operatively
Post-operative pain parameters: 0-100mm Visual analogue scale (VAS) on abduction of ipsilateral arm above the head	At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12 and 24 hours after operation.
Patient satisfaction score	At 24 hours after operation
Incidence of adverse events (Post-operative nausea/vomiting, respiratory depression, pruritus, urinary retention)	From arrival in post-anesthesia care unit to 24 hours post-operatively

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
West, DELHI, India
All India Institute of Medical Sciences
🇮🇳West, DELHI, India
Rebecca Lalnunfel Ralsun
Principal investigator
7896602649
rebeccaralsun777@gmail.com