Comparison of Pain Relief After Hip Fracture Surgery: Hip and Groin Nerve Block

Pain, Postoperative Clinical Trial

Official title:

Comparison of Postoperative Analgesic Efficacy of Pericapsular Nerve Block (PENG) and Suprainguinal Fascia Iliaca Compartment Block(SFICB) in Intertrochanteric Femur Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443892
• Other study ID #: BSH-ANES-MA-01
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: Basaksehir Çam & Sakura City Hospital
• Contact: MUZAFFER GENCER
• Phone: 00905059436459
• Email: dr.m.gencer07[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational prospective double-blind study aims to compare the analgesic effectiveness of the pericapsular nerve group block (PENG) group and the suprainguinal fascia iliaca compartment block(SFICB) group to be applied to relieve postoperative pain in participants over the age of 18 who will be treated under spinal anesthesia with intertrochanteric femur fracture. The main question it aims to answer is:

• Demonstration of whether PENG block or SFICB is more effective for postoperative analgesia in patients who have undergone intertrochanteric femur fracture surgery, based on pain scores, opioid consumption and patient satisfaction.

ıntertrochanteric femur fractures cause severe pain with movement. Postoperatively, participants' movements are severely restricted, increasing the likelihood of complications.

In this study, participants' pain status, VAS score, opioid consumption through patient-controlled analgesia, and satisfaction will be measured with a survey at the end of the 24th hour.

Description:

Intertrochanteric femoral fracture accounts for approximately 45% to 50% of all hip fractures. Intertrochanteric femur fractures cause severe pain with movement. Postoperatively, the movements of the participants are severely restricted, which increases the risk of deep vein thrombosis in the lower extremities, pulmonary infection and mortality in the participants.

Peripheral nerve blocks have been shown to have less impact on hemodynamics, respiratory function, and consciousness than systemic pain relief options. It is recommended as a first-line analgesia program, especially for hip surgeries, with its features of shortening postoperative recovery time, reducing the risk of pneumonia, and not hindering postoperative movement. Fascia Iliaca compartment block used in this area is safe and widely used in postoperative hip fractures. However, to provide effective analgesia for hip surgery, it is necessary to simultaneously block the femoral nerve, lateral femoral cutaneous nerve, and obturator nerve. It has been reported that suprainguinal fascia iliaca compartment block does not provide adequate analgesia and does not reduce opioid consumption because the obturatory nerve cannot be blocked. Therefore, blocking the femoral nerve, obturatory nerve and accessory obturatory nerves with PENG block has led to the idea that postoperative pain scores and opioid consumption will decrease significantly. In this study, we aim to compare the effectiveness of suprainguinal fascia iliaca compartment block and PENG block for postoperative analgesia based on pain scores and opioid consumption in intertrochanteric femur fractures.

Pain is a symptom known to be subjective, and in order to minimize differences between participants, it will be questioned with the Numeric Rating Scale (NRS), which is a standardized scale.

The total narcotic analgesic needs of the block-treated participants will be recorded with the PCA device inserted intravenously postoperatively, and their total Tramadol consumption will be recorded.

Mobilization start times and pain during the mobilization process will be questioned with the Turkish-American Pain Society Revised Patient Outcomes Survey.

The Turkish version of the revised American Pain Society patient outcomes survey for surgical patients will be used to evaluate participants' satisfaction with pain management. According to the confirmatory factor analysis fit indices of the Turkish-Revised American Pain Society Patient Outcomes Questionnaire, whose Cronbach's Alpha value was calculated as 0.88, its three-factor structure was found to be appropriate. The Turkish-Revised American Pain Society Patient Outcomes Questionnaire is a tool to improve the quality of pain management for adult patients. With this questionnaire (1) pain intensity and relief; (2) the impact of pain on activity, sleep, and negative emotions; (3) medication side effects; (4) usefulness of pain management information;(5) ability to participate in pain management decisions; and (6) the use of non-pharmacological techniques will be questioned.

Demographic characteristics of the participants, comorbidities, operation times and complications will be recorded and analyzed statistically.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 1, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Those with Interthorachanteric Femur Fracture

• Patients over 18 years of age

• ASA I-II-III

• Fully oriented and able to cooperate

• Patients who underwent PENG or Suprainguinal Fascia iliaca compartment block for postoperative analgesia after elective surgery.

Exclusion Criteria:

• ASA IV-V

• Patients under 18 years of age

• Presence of active infection in the area to be treated

• Chronic analgesic use

• Patients who cannot cooperate with postoperative pain follow-ups

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Opioid Use
• Pain, Postoperative

Intervention

Procedure:
• Pericapsular Nerve Block (PENG)
Evaluation of postoperative analgesic efficacy of PENG block in participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia.
• Suprainguinal Fascia Iliaca Compartment Block (SFICB)
Evaluation of postoperative analgesic efficacy of SFICB block in participants with intertrochanteric femur fractures undergoing surgery under spinal anesthesia.

Locations

Country	Name	City	State
Turkey	Basaksehir Çam Ve Sakura City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Çam & Sakura City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Allard C, Pardo E, de la Jonquiere C, Wyniecki A, Soulier A, Faddoul A, Tsai ES, Bonnet F, Verdonk F. Comparison between femoral block and PENG block in femoral neck fractures: A cohort study. PLoS One. 2021 Jun 4;16(6):e0252716. doi: 10.1371/journal.pone — View Citation

Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408. — View Citation

Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847. — View Citation

Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24. — View Citation

Kong M, Tang Y, Tong F, Guo H, Zhang XL, Zhou L, Ni H, Wang B, Liu Y, Liu J. The analgesic efficacy of pericapsular nerve group block in patients with intertrochanteric femur fracture: A randomized controlled trial. PLoS One. 2022 Oct 13;17(10):e0275793. — View Citation

Mosaffa F, Taheri M, Manafi Rasi A, Samadpour H, Memary E, Mirkheshti A. Comparison of pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB) for pain control in hip fractures: A double-blind prospective randomized controlled cl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	The Turkish version of the revised American Pain Society patient outcomes survey for surgical patients will be used to evaluate patients' satisfaction with pain management. According to the confirmatory factor analysis fit indices of the Turkish-Revised American Pain Society Patient Outcomes Questionnaire, whose Cronbach's Alpha value was calculated as 0.88, its three-factor structure was found to be appropriate. The Turkish-Revised American Pain Society Patient Outcomes Questionnaire is a tool to improve the quality of pain management for adult patients. With this questionnaire (1) pain intensity and relief; (2) the impact of pain on activity, sleep, and negative emotions; (3) medication side effects; (4) usefulness of pain management information;(5) ability to participate in pain management decisions; and (6) the use of non-pharmacological techniques will be questioned.	At the end of the patient-controlled analgesia procedure
Primary	Effectiveness on pain scores	Postoperative pain assessment is performed using the Numerical Rating Scale (NRS). Participants are asked about their rest pain at 0, 1, 6, 12 and 24 hours after applying a postoperative peripheral nerve block. With this method, participants rate their pain with a precise numerical value from 0 to 10. While zero(0) represents "no pain"; Ten (10) represents the opposite end of the pain continuum (e.g., "The most intense pain imaginable," "As intense pain as possible," "Maximum pain").	At 0, 1, 6, 12 and 24 hours after postoperative peripheral nerve block application
Secondary	Effect on total narcotic analgesic consumption	After the surgery, participants will receive a peripheral nerve block procedure in the postoperative anesthetic care area, and then simultaneously receive intravenous patient-controlled analgesia (PCA) and start an infusion. "Tramadol" was preferred as the treatment method to be used for the PCA method. In preparation for PCA, 400 mg of tramadol is added to 100 cc of physiological saline. As PCA protocol, 1 cc/hour (4 mg/hour) basal infusion dose, 5 cc (20 mg) bolus dose, 30 minutes lockout period (maximum 2 bolus doses in 1 hour) are set. The total number of bolus doses administered by the participants on the PCA device at the end of 24 hours will be recorded and evaluated as the amount of additional opioid needed.	Total number of bolus doses administered at the end of 24 hours of the intravenous PCA device inserted simultaneously after postoperative peripheral nerve block application