Dose and Concentration Relationship for PENG Block in Hip Surgery

NCT05400148 | Completed

• 1 other identifier: 108
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

A number of peripheral nerve blocks are routinely performed in patients who will undergo orthopedic hip surgery for pain relief. Proximal extensor group nerve (PENG) block is one such field block which is used for this purpose and could be performed both before and after the operation. When used before surgery, PENG block is reported to be beneficial in alleviating pain during positioning for spinal anesthesia. Furthermore, some studies suggest a high volume block may increase the analgesic effect of the block. In this perspective, this study aims to observe the effects of different volumes of local anesthetic (bupivacaine) at the same dose used for PENG block in hip fracture positioning for spinal anesthesia. The investigator hypothesizes that a high volume (\>20ml) PENG block will reduce pain during positioning compared to a low volume PENG block.

Conditions

Hip Fractures; Post Operative Pain

Keywords

hip fracture; peripheral nerve blocks; postoperative pain; bupivacaine volume

Outcome Measures

Primary Outcomes (1)

• Sitting pain

  Pain score according to numerical rating scale when patient is brought to sitting position for spinal anesthesia. Numeric rating scale is a patient's self reported pain score between a minimum of "0" and a maximum of "10". Higher numbers indicate worse pain. A score of "0" means that patient suffers no pain at all while a score of "10" means they suffer the worst pain possible.

  30 minutes after PENG block is performed

Secondary Outcomes (5)

• Block pain at rest

  15 minutes after PENG block is performed

• Block pain with movement

  15 minutes after PENG block is performed

• Postoperative pain

  Postoperative 24th hour

• Breakthrough analgesic use

  Postoperative 24th hour

• Delirium

  Postoperative 24th hour

Study Arms (2)

low volume

This cohort will include the patients to whom an analgesic PENG block was administered with a bupivacaine solution volume of up to 20 ml in a dose of 2.5mg/kg-1. This cohort is anticipated to have 56 participants.

Drug: Bupivacaine Hydrochloride

high volume

This cohort will include the patients to whom an analgesic PENG block was administered with a bupivacaine solution volume more than 20 ml in a dose of 2.5mg/kg-1. This cohort is anticipated to have 56 participants.

Drug: Bupivacaine Hydrochloride

Interventions

Bupivacaine Hydrochloride DRUG

Patients who were administered an analgesic PENG block with a dose of 2.5mg/kg with either lov (\<20ml) or high volume (\>20ml)

Also known as: PENG block

high volume; low volume

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected consecutively from those who are admitted to a tertiary care center with a diagnosis of hip fracture and scheduled for a hip surgery in a tertiary care center, until the required sample size is achieved.

You may qualify if:

• Patients over the age of 18 who consent to participate and;
• Patients who are scheduled for hip surgery under spinal anaesthesia,
• Patients who have no neurocognitive disorders that impair cooperation and communication (e.g Alzheimer's disease, Parkinson's disease, senile dementia),
• Patients who have no local anaesthetic allergies,
• Patients to whom an analgesic PENG block was administered preoperatively to facilitate sitting position during spinal anaesthesia will be included.

You may not qualify if:

• Patients under the age of 18,
• Patients who decline to participate,
• Patients who are scheduled for hip surgery under general anaesthesia
• Patients who have neurocognitive disorders
• Patients who have local anaesthetic allergies
• Patients to whom an analgesic PENG block was NOT administered preoperatively to facilitate sitting position during spinal anaesthesia will be excluded.

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip Fractures; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Onur OKUR

  Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: November 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 5, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

TU (1)