PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY

NCT05341869 | Completed

• 1 other identifier: MUGLA-6
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

Brief Summary

Total hysterectomy is one of the most common surgical procedure in gynecology. The laparoscopic route for the performance of hysterectomies are on the rise \[1\]. The laparoscopic hysterectomy (TLH) procedure has several advantages over open surgery such as better cosmetic outcomes, faster recovery earlier return to normal activities and work \[1-3\]. Nonetheless, postoperative pain (PP) remains an issue that scuppers these advantages \[1-3\]. The incidence of PP after TLH has been reported to vary from 35% to 63% \[4,5\]. The origin of PP after laparoscopy is multifactorial and complex such as perioperative predicaments, including pneumoperitoneum, stretching of the intraabdominal cavity, the blood left in the abdomen, and dissection of the pelvic region \[6-7\]. A randomized controlled trial has demonstrated that there may be more intense pain and greater analgesia requirements in the immediate postoperative period after laparoscopic surgery than after laparotomy \[8\]. Further inquiry to intercept the advancement and decrease the severity of PP is prominent to further improve TLH. Women undergoing TLH experience two different pain characteristics including incisional pain and visceral pain in the first hour after the operation \[6\]. These pains were most intense 30 min after TLH, gradually decreasing thereafter for postoperative 72 hr \[6\]. High levels of acute postoperative pain (APP) are pertain with an increment risk of chronic postsurgical pain so control of these acute pains in the urgent postoperative period is vital for faster amelioration. Many attempts have been tried to control APP after THL, such as transverse abdominal plane blocks, superior hypogastric plexus block, local anesthetic injection to the port side, and reduced port caliber \[9-12\]. Para-cervical bloc (PCB) is believed to block the Frankenhouser nerve plexus that supplies the visceral sensory fibers to the uterus, cervix, and top of the vagina. Only two randomized studies have assessed the effect of PCB in THL, but several limitations such as the small sample size preclude drawing conclusions on PP after TLH. Thus, the primary goal of this randomized clinical trial was to investigate if PCB at the onset of surgery, as a part of enhanced recovery protocol, could improve patient recovery after THL.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• visual analog scale (VAS) pain score

  1 h postoperative visual analog scale (VAS) pain score

  up to 1 hour after the procedure

Secondary Outcomes (2)

• the quality of postoperative recovery

  Up to 24 hours after the procedure

• faces pain scale-revised score

  up to 2,4,6,12 hours after the procedure

Study Arms (2)

Control

PLACEBO COMPARATOR

Prior to starting surgery after general anesthesia, the 10 mL of normal saline was performed by the primary surgeon. The syringe was injected with 5 mL on each side into the cervical stroma at 3 and 9 o'clock with a depth of 2 to 3 cm.

Procedure: Para-cervical block

Study

EXPERIMENTAL

Prior to starting surgery after general anesthesia, thE 10 mL of 0.5% bupivacaine with epinephrine was performed by the primary surgeon. The syringe was injected with 5 mL on each side into the cervical stroma at 3 and 9 o'clock with a depth of 2 to 3 cm.

Procedure: Para-cervical block

Interventions

Para-cervical block PROCEDURE

Block of inferior hypogastric plexus with local anesthetic

Control; Study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing total type A laparoscopic hysterectomy with or without additional surgery, such as salpingo-oophorectomy or salpingectomy

You may not qualify if:

• age \< 18 years
• refusal to provide consent
• inability to understand the study questionnaire
• severe psychiatric or mental disorder
• American Society of Anesthesiologists (ASA) physical status classification \> III
• history of regular narcotic use within 6 months of the surgery
• conversion to laparotomy
• operation time \> 90 min
• Additional procedures

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (2)

Mugla Sıtkı Kocman University Education and Research Hospital

Muğla, Mentese, 48000, Turkey (Türkiye)

Location

Kemal Güngördük

Menteşe, Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (1)

• Gungorduk K, Gulseren V, Tastan L, Ozdemir IA. Paracervical block before laparoscopic total hysterectomy: A randomized controlled trial. Taiwan J Obstet Gynecol. 2024 Mar;63(2):186-191. doi: 10.1016/j.tjog.2024.01.013.

  PMID: 38485313 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, associate professor

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 22, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 14, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

TU (2)