Pain Management Protocol in Abdominal Surgeries in City of Erbil

NCT07019103 | Active Not Recruiting DMC

• 2 other identifiers: 2429Hawler medical university
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Intervention Our study involves a novel multimodal pain management protocol for postoperative pain management. The protocol consists of 4 main phases: preoperative, intraoperative, postoperative, and post-discharge phases with different pain management strategies. Each phase is designed to work synergistically with the subsequent phases to optimize pain control and minimize opioid use. All interventions will be administered by trained healthcare professionals and will be tailored to individual patient needs and responses. The protocol will be continuously monitored and adjusted as necessary to ensure optimal pain management while minimizing potential side effects and opioid use. Preoperative phase The preoperative phase focuses on patient education with the aim of educating patients on pain expectations, management strategies, and the recovery process. This is exclusively comprised of educational sessions delivered to each included patient. The sessions are designed to interactively explain the surgical procedure, expected pain levels, and available pain management options using multimedia resources such as videos and brochures. Well-trained pain management specialists will conduct the sessions, and pre-post quizzes will be carried out to ensure optimal patient understanding. Additionally, during this phase, patients will be educated on how to report their perceived pain, rated from 0 to 10 on the visual analog scale (VAS). Subsequently, another dedicated pain-management specialist will engage with each patient to formulate and document an individualized pain management plan, taking into consideration the patient's medical history, previous pain experiences, and preferences for pain management strategies. As part of preemptive analgesia, patients receive 300 mg of gabapentin orally 2 hours prior to surgery, unless contraindicated. 4.2. Intraoperative phase At this phase, our main objective is to utilize effective anesthetic strategies that minimize postoperative pain and accelerate recovery. We will utilize the current standardized protocol, including premedication with midazolam (0.02-0.04 mg/kg IV), induction with propofol (1.5-2.5 mg/kg IV), and maintenance of anesthesia using isoflurane or sevoflurane (0.5-1.5 MAC). When appropriate, patients will also receive ultrasound-guided regional nerve blocks relevant to the surgical site, performed by a trained anesthesiologist, to enhance postoperative pain control. 4.3. Postoperative management Postoperatively, our multimodal management plan aims to maximize pain management, minimize opioid use, and enhance patient recovery. This phase includes complementary both non-pharmacologic and pharmacologic interventions. In particular, non-pharmacologic measures will include physical therapy, cognitive behavioral therapy (CBT), and transcutaneous electrical nerve stimulation (TENS). Pharmacologic intervention in this phase will include optimized use of NSAIDs, tramadol, adjuvant analgesics, and skeletal muscle relaxants in patient-centered, tailored plans that minimize opioid consumption. For the non-pharmacologic part, early mobilization and physical therapy will start on postoperative day 1, with patients engaging in physical activities supervised by a physical therapist. This step will focus on promoting circulation, maintaining muscle strength, and gradually increasing mobility. CBT sessions, conducted by a trained psychologist, will be offered to patients either individually or in groups. These sessions will concentrate on developing pain-coping strategies and stress-reduction techniques. Additionally, transcutaneous electrical nerve stimulation (TENS) units will be made available for patient use as needed, with proper instruction on application and usage provided by nursing staff.

Conditions

Pain Management; Analgesia, Postoperative

Keywords

Pain Management Protocol Postoperative Pain Abdominal Surgery Analgesia (Multimodal) Opioid Consumption Patient Satisfaction Erbil City Iraq

Outcome Measures

Primary Outcomes (1)

• Average Postoperative Pain Intensity (VAS)

  Postoperative pain intensity is measured using a 10-cm Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain). Assessments occur at rest and during movement at 4, 8, 12, 24, and 48 hours postoperative. Nursing staff blinded to group allocation record VAS scores on standardized forms. The primary outcome is the mean of all patient-reported VAS scores during the first 48 hours. Highest and lowest scores are noted, and analgesic administration type and timing are documented. Before each assessment, patients are instructed on marking current pain. Interrater reliability is reinforced through periodic calibration sessions. If a patient cannot self-report, an observational pain scale is recorded but excluded from the primary outcome. Missing VAS data are imputed via last observation carried forward. All data are entered into a secure database. The mean pain intensity for each patient is compared between protocol and control arms to determine protocol effectiveness. Quality checks don

  Up to 48 hours postoperatively (with VAS assessments at 4, 8, 12, 24, and 48 hours)

Study Arms (2)

Standardized Multimodal Pain Management Protocol Arm

EXPERIMENTAL

During the preoperative phase, patients attend one-on-one educational sessions led by pain management specialists. Using videos and brochures, they learn about the surgery, expected pain levels, and both pharmacologic and nonpharmacologic management options. Pre- and post-session quizzes check comprehension and ensure patients can report pain using the visual analog scale (VAS) from 0 to 10. Then, a second specialist develops and documents a personalized pain management plan considering medical history, past pain experiences, and preferences. As preemptive analgesia, patients receive 300 mg oral gabapentin two hours before surgery, if not contraindicated. Brief discussion of sensory and emotional aspects of pain also prepares patients psychologically. Detailed documentation in the record promotes continuity of care. This combined approach aims to improve postoperative pain control, decrease opioid use, facilitate early mobilization, and enhance patient satisfaction. Enhanced outcomes.

Drug: Gabapentin (Neurontin® (Registered Trademark))

Control

NO INTERVENTION

routine hospital care

Interventions

Gabapentin (Neurontin® (Registered Trademark)) DRUG

Additionally, during this phase, patients will be educated on how to report their perceived pain, rated from 0 to 10 on the visual analog scale (VAS). Subsequently, another dedicated pain-management specialist will engage with each patient to formulate and document an individualized pain management plan, taking into consideration the patient's medical history, previous pain experiences, and preferences for pain management strategies. As part of preemptive analgesia, patients receive 300 mg of gabapentin orally 2 hours prior to surgery, unless contraindicated.

Standardized Multimodal Pain Management Protocol Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Scheduled for elective abdominal surgery (including but not limited to cholecystectomy, appendectomy, hernia repair, and bowel resection).
• American Society of Anesthesiologists (ASA) physical status classification I-III
• Able to provide written informed consent.
• Capable of understanding and complying with the study protocol, including pain assessments and follow-up requirements.

You may not qualify if:

• \. Emergency or urgent abdominal surgeries 2. Chronic pain conditions requiring daily opioid use (\>30 morphine milligram equivalents per day) for ≥3 months prior to surgery 3. History of substance abuse disorder within the past 5 years 4. Severe hepatic impairment (Child-Pugh class C) or renal dysfunction (estimated glomerular filtration rate \<30 mL/min/1.73m²) 5. Allergies or contraindications to any component of the multimodal pain management protocol 6. Cognitive impairment preventing reliable self-reporting of pain scores 7. Pregnancy or breastfeeding

Sponsors & Collaborators

• Haroon Muhammad Khalil: lead

Study Sites (1)

Hawler Medical University/College of nursing

Erbil, Erbil Governorate, 44001, Iraq

Location

Related Publications (1)

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Effects of Pain Management Protocol on Patient's Undergoing Abdominal Surgeries in Erbil City Hospitals

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: March 2, 2025
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)